Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Dry Powder for Inhalation, Chronic Obstructive Pulmonary Disease, Lung Function testing
Brief summary
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
Interventions
DRUGUK-432,097
Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
DRUGPlacebo
Capsules containing 100% lactose administered BID using an atomizer device
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease * Patients must have a smoking history of at least 10 pack-years * Patients must have stable disease for at least 1 month prior to screening.
Exclusion criteria
* More than 2 exacerbations of COPD in the preceding year * History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization. * History or presence of respiratory failure, cor pulmonale or right ventricular failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Pre-dose at Baseline, Week 6 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6 | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration. |
| Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week. |
| Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | Participants were issued with rescue medication (Salbutamol MDI \[100 mcg/actuation\]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week. |
| Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8 | The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week. |
| Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Week 6 | CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Week 6 | PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected. |
| Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Pre-dose at Baseline, Week 2, 4, 8 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. |
| Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Pre-dose at Baseline, Week 2, 4, 6, 8 | FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration. |
| Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Pre-dose at Baseline, Week 2, 4, 6, 8 | FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration. |
| Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Pre-dose at Baseline, Week 2, 4, 6, 8 | IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration. |
| Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. |
| Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6 | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration. |
| Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6 | 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6 | FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration. |
| Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration. |
| Change From Baseline in Post-Bronchodilator FEV6 at Week 6 | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration. |
| Change From Baseline in Post-Bronchodilator FVC at Week 6 | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration. |
| Change From Baseline in Post-Bronchodilator IC at Week 6 | 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6 | IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration. |
| Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | Baseline, Week 2, 4, 6 | BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up) | Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia's formula (QTcF=QT divided by cube root of RR Int) and Bazett's formula (QTcB=QT divided by square root of RR Int). |
| Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up) | Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate. |
| Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6 | Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration. |
| Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4 | BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes. |
| Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4 | Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm). |
Countries
Australia, Canada, Netherlands, Poland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UK-432,097 150 Mcg UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | 17 |
| UK-432,097 450 Mcg UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | 18 |
| UK-432,097 1350 Mcg UK-432,097 1350 mcg (3 \* 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | 35 |
| Placebo Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required. | 17 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 | 1 |
| Overall Study | Laboratory abnormality | 1 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 5 | 0 |
Baseline characteristics
| Characteristic | UK-432,097 150 Mcg | UK-432,097 450 Mcg | UK-432,097 1350 Mcg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Customized 45 to 64 Years | 8 participants | 7 participants | 12 participants | 9 participants | 36 participants |
| Age, Customized Greater Than or Equal to (>=) 65 Years | 9 participants | 11 participants | 23 participants | 8 participants | 51 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 9 Participants | 6 Participants | 25 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 26 Participants | 11 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 17 | 8 / 18 | 11 / 35 | 10 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 | 0 / 35 | 0 / 17 |
Outcome results
Primary
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Time frame: Pre-dose at Baseline, Week 6
Population: Full analysis set (FAS): all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Missing data were imputed using Last Observation Carried Forward (LOCF). Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Baseline (n= 16, 17, 32, 16) | 1.40 liter | Standard Deviation 0.45 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Change at Week 6 (n= 14, 17, 29, 15) | -0.01 liter | Standard Deviation 0.21 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Baseline (n= 16, 17, 32, 16) | 1.48 liter | Standard Deviation 0.57 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Change at Week 6 (n= 14, 17, 29, 15) | -0.05 liter | Standard Deviation 0.18 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Change at Week 6 (n= 14, 17, 29, 15) | -0.05 liter | Standard Deviation 0.18 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Baseline (n= 16, 17, 32, 16) | 1.41 liter | Standard Deviation 0.39 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Baseline (n= 16, 17, 32, 16) | 1.33 liter | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 | Change at Week 6 (n= 14, 17, 29, 15) | -0.05 liter | Standard Deviation 0.16 |
Comparison: The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.p-value: 0.028495% CI: [-0.0943, 0.0774]Bayesian NDLM model
Comparison: The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.p-value: 0.005695% CI: [-0.1299, 0.0471]Bayesian NDLM model
Comparison: The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.p-value: 0.000995% CI: [-0.1298, 0.029]Bayesian NDLM model
Secondary
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 2(n=16, 15, 31, 16) | -0.13 units on a scale | Standard Deviation 0.48 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 6 (n= 15, 17, 30, 15) | -0.10 units on a scale | Standard Deviation 0.36 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 1 (n= 16, 17, 31, 16) | -0.07 units on a scale | Standard Deviation 0.26 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 4 (n= 14, 17, 30, 16) | -0.04 units on a scale | Standard Deviation 0.3 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 4(n=14, 17, 30, 16) | -0.18 units on a scale | Standard Deviation 0.5 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 6(n=15, 17, 30, 15) | -0.12 units on a scale | Standard Deviation 0.56 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 5 (n= 15, 17, 30, 16) | 0.06 units on a scale | Standard Deviation 0.23 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 5 (n= 15, 17, 30, 16) | -0.13 units on a scale | Standard Deviation 0.38 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 3(n=15, 17, 31, 16) | -0.12 units on a scale | Standard Deviation 0.57 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 2 (n= 16, 15, 31, 16) | -0.05 units on a scale | Standard Deviation 0.2 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 7(n=15, 16, 30, 15) | -0.06 units on a scale | Standard Deviation 0.43 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 7 (n= 15, 15, 30, 15) | 0.08 units on a scale | Standard Deviation 0.23 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 4 (n= 14, 17, 30, 16) | 0.01 units on a scale | Standard Deviation 0.21 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 7 (n= 15, 16, 30, 15) | -0.16 units on a scale | Standard Deviation 0.38 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 8 (n= 15, 15, 28, 15) | 0.07 units on a scale | Standard Deviation 0.27 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 8(n=15, 16, 28, 15) | -0.04 units on a scale | Standard Deviation 0.49 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Baseline (n= 16, 17, 31, 16) | 1.00 units on a scale | Standard Deviation 0.62 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 8 (n= 15, 16, 28, 15) | -0.15 units on a scale | Standard Deviation 0.37 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 3 (n= 15, 17, 31, 16) | -0.06 units on a scale | Standard Deviation 0.51 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 6 (n= 15, 17, 30, 15) | 0.09 units on a scale | Standard Deviation 0.09 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 3 (n= 15, 17, 31, 16) | -0.08 units on a scale | Standard Deviation 0.32 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Baseline (n= 16, 17, 31, 16) | 1.31 units on a scale | Standard Deviation 0.59 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 1 (n= 16, 17, 31, 16) | -0.08 units on a scale | Standard Deviation 0.46 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 2 (n= 16, 15, 31, 16) | -0.10 units on a scale | Standard Deviation 0.43 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 5(n=15, 17, 30, 16) | -0.14 units on a scale | Standard Deviation 0.47 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 1(n=16, 17, 31, 16) | -0.24 units on a scale | Standard Deviation 0.45 |
| UK-432,097 150 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Baseline (n= 16, 17, 31, 16) | 1.09 units on a scale | Standard Deviation 0.5 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 1(n=16, 17, 31, 16) | -0.10 units on a scale | Standard Deviation 0.31 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 3(n=15, 17, 31, 16) | -0.15 units on a scale | Standard Deviation 0.33 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 1 (n= 16, 17, 31, 16) | 0.10 units on a scale | Standard Deviation 0.36 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Baseline (n= 16, 17, 31, 16) | 0.76 units on a scale | Standard Deviation 0.79 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 4(n=14, 17, 30, 16) | -0.16 units on a scale | Standard Deviation 0.5 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 2 (n= 16, 15, 31, 16) | 0.13 units on a scale | Standard Deviation 0.31 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 5(n=15, 17, 30, 16) | -0.22 units on a scale | Standard Deviation 0.5 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 8 (n= 15, 15, 28, 15) | -0.06 units on a scale | Standard Deviation 0.4 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 7(n=15, 16, 30, 15) | -0.21 units on a scale | Standard Deviation 0.48 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 6(n=15, 17, 30, 15) | -0.03 units on a scale | Standard Deviation 0.5 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 7 (n= 15, 15, 30, 15) | -0.02 units on a scale | Standard Deviation 0.39 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Baseline (n= 16, 17, 31, 16) | 0.77 units on a scale | Standard Deviation 0.75 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 1 (n= 16, 17, 31, 16) | 0.11 units on a scale | Standard Deviation 0.48 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 3 (n= 15, 17, 31, 16) | 0.15 units on a scale | Standard Deviation 0.32 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 5 (n= 15, 17, 30, 16) | 0.15 units on a scale | Standard Deviation 0.33 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 4 (n= 14, 17, 30, 16) | 0.07 units on a scale | Standard Deviation 0.38 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 6 (n= 15, 17, 30, 15) | 0.04 units on a scale | Standard Deviation 0.43 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 5 (n= 15, 17, 30, 16) | 0.04 units on a scale | Standard Deviation 0.44 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 2(n=16, 15, 31, 16) | -0.11 units on a scale | Standard Deviation 0.29 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 4 (n= 14, 17, 30, 16) | 0.15 units on a scale | Standard Deviation 0.36 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 7 (n= 15, 16, 30, 15) | -0.08 units on a scale | Standard Deviation 0.57 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 3 (n= 15, 17, 31, 16) | 0.20 units on a scale | Standard Deviation 0.37 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 8 (n= 15, 16, 28, 15) | 0.00 units on a scale | Standard Deviation 0.56 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 8(n=15, 16, 28, 15) | -0.13 units on a scale | Standard Deviation 0.51 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Baseline (n= 16, 17, 31, 16) | 1.30 units on a scale | Standard Deviation 0.6 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 2 (n= 16, 15, 31, 16) | 0.17 units on a scale | Standard Deviation 0.37 |
| UK-432,097 450 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 6 (n= 15, 17, 30, 15) | 0.10 units on a scale | Standard Deviation 0.46 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 1 (n= 16, 17, 31, 16) | 0.07 units on a scale | Standard Deviation 0.41 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 2 (n= 16, 15, 31, 16) | 0.10 units on a scale | Standard Deviation 0.53 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 8(n=15, 16, 28, 15) | -0.04 units on a scale | Standard Deviation 0.49 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 1 (n= 16, 17, 31, 16) | 0.04 units on a scale | Standard Deviation 0.39 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 5 (n= 15, 17, 30, 16) | 0.07 units on a scale | Standard Deviation 0.48 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 7 (n= 15, 15, 30, 15) | 0.07 units on a scale | Standard Deviation 0.56 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Baseline (n= 16, 17, 31, 16) | 1.11 units on a scale | Standard Deviation 0.67 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 3 (n= 15, 17, 31, 16) | 0.07 units on a scale | Standard Deviation 0.48 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 4 (n= 14, 17, 30, 16) | -0.03 units on a scale | Standard Deviation 0.46 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 5 (n= 15, 17, 30, 16) | 0.10 units on a scale | Standard Deviation 0.73 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 6 (n= 15, 17, 30, 15) | 0.07 units on a scale | Standard Deviation 0.77 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 7 (n= 15, 16, 30, 15) | 0.00 units on a scale | Standard Deviation 0.64 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 8 (n= 15, 16, 28, 15) | -0.15 units on a scale | Standard Deviation 0.6 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Baseline (n= 16, 17, 31, 16) | 1.15 units on a scale | Standard Deviation 0.75 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 1(n=16, 17, 31, 16) | -0.05 units on a scale | Standard Deviation 0.23 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 2(n=16, 15, 31, 16) | 0.00 units on a scale | Standard Deviation 0.33 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 3(n=15, 17, 31, 16) | 0.02 units on a scale | Standard Deviation 0.33 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 4(n=14, 17, 30, 16) | -0.07 units on a scale | Standard Deviation 0.28 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 5(n=15, 17, 30, 16) | -0.06 units on a scale | Standard Deviation 0.33 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 6(n=15, 17, 30, 15) | -0.05 units on a scale | Standard Deviation 0.34 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 7(n=15, 16, 30, 15) | 0.01 units on a scale | Standard Deviation 0.36 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Baseline (n= 16, 17, 31, 16) | 0.95 units on a scale | Standard Deviation 0.59 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 2 (n= 16, 15, 31, 16) | 0.14 units on a scale | Standard Deviation 0.54 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 3 (n= 15, 17, 31, 16) | 0.15 units on a scale | Standard Deviation 0.52 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 4 (n= 14, 17, 30, 16) | 0.06 units on a scale | Standard Deviation 0.51 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 6 (n= 15, 17, 30, 15) | 0.10 units on a scale | Standard Deviation 0.61 |
| UK-432,097 1350 Mcg | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 8 (n= 15, 15, 28, 15) | 0.02 units on a scale | Standard Deviation 0.47 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 2(n=16, 15, 31, 16) | -0.01 units on a scale | Standard Deviation 0.38 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 1 (n= 16, 17, 31, 16) | 0.04 units on a scale | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 1(n=16, 17, 31, 16) | 0.00 units on a scale | Standard Deviation 0.32 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Baseline (n= 16, 17, 31, 16) | 1.27 units on a scale | Standard Deviation 0.54 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 7 (n= 15, 15, 30, 15) | 0.03 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 2 (n= 16, 15, 31, 16) | 0.05 units on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 8 (n= 15, 16, 28, 15) | 0.07 units on a scale | Standard Deviation 0.47 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 7 (n= 15, 16, 30, 15) | 0.07 units on a scale | Standard Deviation 0.31 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 2 (n= 16, 15, 31, 16) | -0.01 units on a scale | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 3 (n= 15, 17, 31, 16) | 0.05 units on a scale | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 6 (n= 15, 17, 30, 15) | -0.02 units on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 5 (n= 15, 17, 30, 16) | 0.00 units on a scale | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 1 (n= 16, 17, 31, 16) | 0.10 units on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 4 (n= 14, 17, 30, 16) | 0.01 units on a scale | Standard Deviation 0.47 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 4 (n= 14, 17, 30, 16) | 0.18 units on a scale | Standard Deviation 0.39 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Change at Week 3 (n= 15, 17, 31, 16) | 0.15 units on a scale | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 5 (n= 15, 17, 30, 16) | -0.04 units on a scale | Standard Deviation 0.44 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Cough: Baseline (n= 16, 17, 31, 16) | 1.06 units on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Baseline (n= 16, 17, 31, 16) | 0.90 units on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 8 (n= 15, 15, 28, 15) | -0.03 units on a scale | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 6(n=15, 17, 30, 15) | 0.12 units on a scale | Standard Deviation 0.47 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 5(n=15, 17, 30, 16) | 0.13 units on a scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Sputum: Change at Week 6 (n= 15, 17, 30, 15) | -0.02 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 7(n=15, 16, 30, 15) | 0.10 units on a scale | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 8(n=15, 16, 28, 15) | 0.08 units on a scale | Standard Deviation 0.45 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 4(n=14, 17, 30, 16) | 0.18 units on a scale | Standard Deviation 0.34 |
| Placebo | Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Breathlessness: Change at Week 3(n=15, 17, 31, 16) | 0.13 units on a scale | Standard Deviation 0.41 |
Comparison: Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9102Mixed Models Analysis
Comparison: Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8757Mixed Models Analysis
Comparison: Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6334Mixed Models Analysis
Comparison: Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5448Mixed Models Analysis
Comparison: Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6986Mixed Models Analysis
Comparison: Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3151Mixed Models Analysis
Comparison: Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1802Mixed Models Analysis
Comparison: Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6391Mixed Models Analysis
Comparison: Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6838Mixed Models Analysis
Comparison: Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9648Mixed Models Analysis
Comparison: Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8961Mixed Models Analysis
Comparison: Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9534Mixed Models Analysis
Comparison: Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7726Mixed Models Analysis
Comparison: Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5665Mixed Models Analysis
Comparison: Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2684Mixed Models Analysis
Comparison: Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6485Mixed Models Analysis
Comparison: Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4821Mixed Models Analysis
Comparison: Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2557Mixed Models Analysis
Comparison: Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9031Mixed Models Analysis
Comparison: Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8634Mixed Models Analysis
Comparison: Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6375Mixed Models Analysis
Comparison: Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8775Mixed Models Analysis
Comparison: Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7191Mixed Models Analysis
Comparison: Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8677Mixed Models Analysis
Comparison: Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9838Mixed Models Analysis
Comparison: Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8106Mixed Models Analysis
Comparison: Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.775Mixed Models Analysis
Comparison: Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8082Mixed Models Analysis
Comparison: Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7678Mixed Models Analysis
Comparison: Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5373Mixed Models Analysis
Comparison: Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9548Mixed Models Analysis
Comparison: Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9743Mixed Models Analysis
Comparison: Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8408Mixed Models Analysis
Comparison: Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9887Mixed Models Analysis
Comparison: Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9918Mixed Models Analysis
Comparison: Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9833Mixed Models Analysis
Comparison: Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9619Mixed Models Analysis
Comparison: Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9917Mixed Models Analysis
Comparison: Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9376Mixed Models Analysis
Comparison: Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9084Mixed Models Analysis
Comparison: Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7906Mixed Models Analysis
Comparison: Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8765Mixed Models Analysis
Comparison: Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8469Mixed Models Analysis
Comparison: Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9717Mixed Models Analysis
Comparison: Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7591Mixed Models Analysis
Comparison: Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7141Mixed Models Analysis
Comparison: Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8104Mixed Models Analysis
Comparison: Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7664Mixed Models Analysis
Comparison: Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7888Mixed Models Analysis
Comparison: Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.393Mixed Models Analysis
Comparison: Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4785Mixed Models Analysis
Comparison: Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6756Mixed Models Analysis
Comparison: Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2627Mixed Models Analysis
Comparison: Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2281Mixed Models Analysis
Comparison: Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7656Mixed Models Analysis
Comparison: Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2105Mixed Models Analysis
Comparison: Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2221Mixed Models Analysis
Comparison: Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4396Mixed Models Analysis
Comparison: Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2243Mixed Models Analysis
Comparison: Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3597Mixed Models Analysis
Comparison: Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.203Mixed Models Analysis
Comparison: Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1207Mixed Models Analysis
Comparison: Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1836Mixed Models Analysis
Comparison: Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2359Mixed Models Analysis
Comparison: Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2861Mixed Models Analysis
Comparison: Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2151Mixed Models Analysis
Comparison: Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3545Mixed Models Analysis
Comparison: Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7102Mixed Models Analysis
Comparison: Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3883Mixed Models Analysis
Comparison: Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2228Mixed Models Analysis
Comparison: Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6342Mixed Models Analysis
Comparison: Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3141Mixed Models Analysis
Secondary
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.
Time frame: Baseline, Week 2, 4, 6
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 6 (n= 14, 16, 29, 15) | -0.6 units on a scale | Standard Deviation 2.3 |
| UK-432,097 150 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 4 (n= 15, 17, 31, 16) | 0.5 units on a scale | Standard Deviation 2.8 |
| UK-432,097 150 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | BDI (n= 16, 17, 32, 16) | 7.1 units on a scale | Standard Deviation 1.9 |
| UK-432,097 150 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 2 (n= 16, 17, 32, 16) | -0.2 units on a scale | Standard Deviation 1.9 |
| UK-432,097 450 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 2 (n= 16, 17, 32, 16) | 0.8 units on a scale | Standard Deviation 1.9 |
| UK-432,097 450 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | BDI (n= 16, 17, 32, 16) | 7.6 units on a scale | Standard Deviation 2.1 |
| UK-432,097 450 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 6 (n= 14, 16, 29, 15) | 0.9 units on a scale | Standard Deviation 3.1 |
| UK-432,097 450 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 4 (n= 15, 17, 31, 16) | 0.2 units on a scale | Standard Deviation 1.7 |
| UK-432,097 1350 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | BDI (n= 16, 17, 32, 16) | 7.2 units on a scale | Standard Deviation 2.1 |
| UK-432,097 1350 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 6 (n= 14, 16, 29, 15) | 0.1 units on a scale | Standard Deviation 2.4 |
| UK-432,097 1350 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 4 (n= 15, 17, 31, 16) | -0.3 units on a scale | Standard Deviation 1.9 |
| UK-432,097 1350 Mcg | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 2 (n= 16, 17, 32, 16) | 0.2 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 6 (n= 14, 16, 29, 15) | 1.0 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 2 (n= 16, 17, 32, 16) | 1.3 units on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | TDI at Week 4 (n= 15, 17, 31, 16) | 0.3 units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6 | BDI (n= 16, 17, 32, 16) | 7.1 units on a scale | Standard Deviation 2 |
Comparison: TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9885Mixed Models Analysis
Comparison: TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8055Mixed Models Analysis
Comparison: TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9759Mixed Models Analysis
Comparison: TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4401Mixed Models Analysis
Comparison: TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5957Mixed Models Analysis
Comparison: TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8302Mixed Models Analysis
Comparison: TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9657Mixed Models Analysis
Comparison: TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6378Mixed Models Analysis
Comparison: TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.899Mixed Models Analysis
Secondary
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.
Time frame: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Baseline (n= 16, 17, 32, 16) | 220.0 liter per minute | Standard Deviation 113 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 8 (n= 15, 16, 27, 15) | -9.5 liter per minute | Standard Deviation 26.8 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 7 (n= 15, 16, 29, 15) | -8.3 liter per minute | Standard Deviation 22.1 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 5 (n= 15, 17, 30, 16) | -13.4 liter per minute | Standard Deviation 27.2 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 5 (n= 15, 17, 30, 16) | -5.4 liter per minute | Standard Deviation 23.6 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -10.5 liter per minute | Standard Deviation 27.2 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 1 (n= 16, 17, 32, 16) | -3.6 liter per minute | Standard Deviation 17.5 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 8 (n= 15, 16, 28, 15) | -2.6 liter per minute | Standard Deviation 21.9 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 4 (n= 15, 17, 31, 16) | -1.5 liter per minute | Standard Deviation 21.5 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 2 (n= 16, 17, 32, 16) | 4.8 liter per minute | Standard Deviation 27.1 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 2 (n= 16, 17, 32, 16) | -5.0 liter per minute | Standard Deviation 21 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 7 (n= 15, 16, 30, 15) | 0.8 liter per minute | Standard Deviation 23.7 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 1 (n= 16, 17, 32, 16) | 5.5 liter per minute | Standard Deviation 20.5 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Baseline (n= 16, 17, 32, 16) | 242.9 liter per minute | Standard Deviation 111.8 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 3 (n= 15, 17, 31, 16) | -8.8 liter per minute | Standard Deviation 27.5 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -5.5 liter per minute | Standard Deviation 26.8 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 3 (n= 15, 17, 31, 16) | 0.1 liter per minute | Standard Deviation 16.2 |
| UK-432,097 150 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 4 (n= 15, 17, 31, 16) | -5.9 liter per minute | Standard Deviation 24.2 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 4 (n= 15, 17, 31, 16) | -2.8 liter per minute | Standard Deviation 18.4 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Baseline (n= 16, 17, 32, 16) | 236.4 liter per minute | Standard Deviation 121.4 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 1 (n= 16, 17, 32, 16) | 3.5 liter per minute | Standard Deviation 17.8 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 2 (n= 16, 17, 32, 16) | -6.0 liter per minute | Standard Deviation 18.6 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 3 (n= 15, 17, 31, 16) | -6.2 liter per minute | Standard Deviation 17.8 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 5 (n= 15, 17, 30, 16) | -4.4 liter per minute | Standard Deviation 21.5 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -4.9 liter per minute | Standard Deviation 21 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 7 (n= 15, 16, 29, 15) | -0.0 liter per minute | Standard Deviation 24.3 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 8 (n= 15, 16, 27, 15) | -6.8 liter per minute | Standard Deviation 29.4 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Baseline (n= 16, 17, 32, 16) | 269.3 liter per minute | Standard Deviation 123.1 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 1 (n= 16, 17, 32, 16) | -0.2 liter per minute | Standard Deviation 16.8 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 2 (n= 16, 17, 32, 16) | -8.7 liter per minute | Standard Deviation 19.6 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 3 (n= 15, 17, 31, 16) | -17.0 liter per minute | Standard Deviation 28.6 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 4 (n= 15, 17, 31, 16) | -13.7 liter per minute | Standard Deviation 19.3 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 5 (n= 15, 17, 30, 16) | -14.2 liter per minute | Standard Deviation 24.7 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -13.6 liter per minute | Standard Deviation 23.2 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 7 (n= 15, 16, 30, 15) | -10.7 liter per minute | Standard Deviation 21.6 |
| UK-432,097 450 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 8 (n= 15, 16, 28, 15) | -16.0 liter per minute | Standard Deviation 23.4 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 4 (n= 15, 17, 31, 16) | 3.3 liter per minute | Standard Deviation 31.2 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -7.3 liter per minute | Standard Deviation 27.7 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 8 (n= 15, 16, 27, 15) | 0.4 liter per minute | Standard Deviation 30.2 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Baseline (n= 16, 17, 32, 16) | 250.0 liter per minute | Standard Deviation 78.7 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 2 (n= 16, 17, 32, 16) | -1.3 liter per minute | Standard Deviation 21.3 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 1 (n= 16, 17, 32, 16) | 3.2 liter per minute | Standard Deviation 19.7 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 8 (n= 15, 16, 28, 15) | -3.4 liter per minute | Standard Deviation 30.6 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 7 (n= 15, 16, 30, 15) | -6.0 liter per minute | Standard Deviation 30.7 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 1 (n= 16, 17, 32, 16) | 2.1 liter per minute | Standard Deviation 13.9 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 4 (n= 15, 17, 31, 16) | -0.7 liter per minute | Standard Deviation 23.6 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Baseline (n= 16, 17, 32, 16) | 213.6 liter per minute | Standard Deviation 72.6 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 5 (n= 15, 17, 30, 16) | -8.6 liter per minute | Standard Deviation 27 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 5 (n= 15, 17, 30, 16) | -9.4 liter per minute | Standard Deviation 27.5 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 3 (n= 15, 17, 31, 16) | 1.6 liter per minute | Standard Deviation 22.9 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -3.9 liter per minute | Standard Deviation 36.6 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 2 (n= 16, 17, 32, 16) | 0.4 liter per minute | Standard Deviation 25.9 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 7 (n= 15, 16, 29, 15) | 1.2 liter per minute | Standard Deviation 33.7 |
| UK-432,097 1350 Mcg | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 3 (n= 15, 17, 31, 16) | 1.9 liter per minute | Standard Deviation 26.4 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 7 (n= 15, 16, 29, 15) | -2.8 liter per minute | Standard Deviation 26.7 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 4 (n= 15, 17, 31, 16) | 1.6 liter per minute | Standard Deviation 28.5 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Baseline (n= 16, 17, 32, 16) | 191.0 liter per minute | Standard Deviation 77.8 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 8 (n= 15, 16, 27, 15) | 0.8 liter per minute | Standard Deviation 23.1 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 2 (n= 16, 17, 32, 16) | 0.7 liter per minute | Standard Deviation 27.2 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -4.5 liter per minute | Standard Deviation 40.2 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 6 (n= 15, 17, 30, 15) | -6.1 liter per minute | Standard Deviation 26.8 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Baseline (n= 16, 17, 32, 16) | 207.1 liter per minute | Standard Deviation 88.2 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 4 (n= 15, 17, 31, 16) | 2.8 liter per minute | Standard Deviation 28.9 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 3 (n= 15, 17, 31, 16) | 2.6 liter per minute | Standard Deviation 22.4 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 5 (n= 15, 17, 30, 16) | 9.5 liter per minute | Standard Deviation 36.7 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 1 (n= 16, 17, 32, 16) | 5.2 liter per minute | Standard Deviation 19.5 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 1 (n= 16, 17, 32, 16) | 1.1 liter per minute | Standard Deviation 23 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Morning PEFR: Change at Week 5 (n= 15, 17, 30, 16) | 5.7 liter per minute | Standard Deviation 31 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 2 (n= 16, 17, 32, 16) | 8.5 liter per minute | Standard Deviation 37.8 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 3 (n= 15, 17, 31, 16) | 7.6 liter per minute | Standard Deviation 27.7 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 8 (n= 15, 16, 28, 15) | -5.9 liter per minute | Standard Deviation 41.9 |
| Placebo | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Evening PEFR: Change at Week 7 (n= 15, 16, 30, 15) | -1.0 liter per minute | Standard Deviation 34.5 |
Comparison: Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7292Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2768Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3795Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7374Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7615Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5811Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8939Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8117Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4393Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8055Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6767Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.407Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9705Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8249Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9345Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7384Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5239Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.417Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7695Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4566Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3535Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8598Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8005Mixed Models Analysis
Comparison: Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3441Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4436Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7238Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5743Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.619Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9473Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8014Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7929Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9963Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7387Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6286Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9538Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5701Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9242Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9876Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9802Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5705Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8063Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6667Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.464Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8821Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7591Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4001Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8707Mixed Models Analysis
Comparison: Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4629Mixed Models Analysis
Secondary
Change From Baseline in Post-Bronchodilator FEV1 at Week 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'N'(number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Baseline | 0.32 liter | Standard Deviation 0.2 |
| UK-432,097 150 Mcg | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Change at Week 6 | 0.06 liter | Standard Deviation 0.14 |
| UK-432,097 450 Mcg | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Change at Week 6 | 0.03 liter | Standard Deviation 0.19 |
| UK-432,097 450 Mcg | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Baseline | 0.29 liter | Standard Deviation 0.19 |
| UK-432,097 1350 Mcg | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Change at Week 6 | -0.02 liter | Standard Deviation 0.19 |
| UK-432,097 1350 Mcg | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Baseline | 0.26 liter | Standard Deviation 0.18 |
| Placebo | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Change at Week 6 | -0.06 liter | Standard Deviation 0.14 |
| Placebo | Change From Baseline in Post-Bronchodilator FEV1 at Week 6 | Baseline | 0.24 liter | Standard Deviation 0.15 |
Secondary
Change From Baseline in Post-Bronchodilator FEV6 at Week 6
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Population: Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.
Secondary
Change From Baseline in Post-Bronchodilator FVC at Week 6
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Population: Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.
Secondary
Change From Baseline in Post-Bronchodilator IC at Week 6
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Population: Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.
Secondary
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 2 (n= 16, 16, 30, 16) | 0.02 liter | Standard Deviation 0.11 |
| UK-432,097 150 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Baseline (n= 16, 17, 32, 16) | 1.40 liter | Standard Deviation 0.45 |
| UK-432,097 150 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 4 (n= 14, 16, 29, 16) | -0.07 liter | Standard Deviation 0.15 |
| UK-432,097 150 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 6 (n= 13, 16, 27, 15) | -0.06 liter | Standard Deviation 0.23 |
| UK-432,097 450 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 2 (n= 16, 16, 30, 16) | -0.10 liter | Standard Deviation 0.16 |
| UK-432,097 450 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 4 (n= 14, 16, 29, 16) | -0.04 liter | Standard Deviation 0.1 |
| UK-432,097 450 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Baseline (n= 16, 17, 32, 16) | 1.48 liter | Standard Deviation 0.57 |
| UK-432,097 450 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 6 (n= 13, 16, 27, 15) | -0.04 liter | Standard Deviation 0.18 |
| UK-432,097 1350 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Baseline (n= 16, 17, 32, 16) | 1.41 liter | Standard Deviation 0.39 |
| UK-432,097 1350 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 2 (n= 16, 16, 30, 16) | -0.02 liter | Standard Deviation 0.11 |
| UK-432,097 1350 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 6 (n= 13, 16, 27, 15) | -0.04 liter | Standard Deviation 0.15 |
| UK-432,097 1350 Mcg | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 4 (n= 14, 16, 29, 16) | -0.02 liter | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 6 (n= 13, 16, 27, 15) | -0.03 liter | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 4 (n= 14, 16, 29, 16) | -0.01 liter | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Change at Week 2 (n= 16, 16, 30, 16) | 0.03 liter | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6 | Baseline (n= 16, 17, 32, 16) | 1.33 liter | Standard Deviation 0.48 |
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5549Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.988Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8572Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8402Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6562Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5632Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.637Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4686Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6164Mixed Models Analysis
Secondary
Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Population: Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.
Secondary
Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Population: Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.
Secondary
Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Population: Data for this pre-specified outcome was not analyzed, as the study was terminated due to futility based on results of interim analysis.
Secondary
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
Participants were issued with rescue medication (Salbutamol MDI \[100 mcg/actuation\]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Baseline (n= 14, 15, 27, 15) | 2.87 puffs/day | Standard Deviation 2.91 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 1 (n= 14, 15, 27, 15) | -0.24 puffs/day | Standard Deviation 0.51 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 8 (n= 13, 13, 25, 14) | -0.17 puffs/day | Standard Deviation 1.31 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 5 (n= 13, 14, 26, 15) | -0.44 puffs/day | Standard Deviation 0.98 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 4 (n= 13, 14, 26, 15) | -0.19 puffs/day | Standard Deviation 0.56 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 2 (n= 13, 13, 27, 15) | -0.26 puffs/day | Standard Deviation 0.58 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 3 (n= 13, 14, 27, 15) | -0.12 puffs/day | Standard Deviation 0.63 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 7 (n= 13, 13, 26, 14) | -0.20 puffs/day | Standard Deviation 1.05 |
| UK-432,097 150 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 6 (n= 13, 14, 24, 14) | -0.39 puffs/day | Standard Deviation 1.17 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 2 (n= 13, 13, 27, 15) | -0.14 puffs/day | Standard Deviation 0.67 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Baseline (n= 14, 15, 27, 15) | 3.32 puffs/day | Standard Deviation 2.99 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 7 (n= 13, 13, 26, 14) | -0.01 puffs/day | Standard Deviation 1.81 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 8 (n= 13, 13, 25, 14) | 0.02 puffs/day | Standard Deviation 1.51 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 1 (n= 14, 15, 27, 15) | -0.17 puffs/day | Standard Deviation 0.53 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 3 (n= 13, 14, 27, 15) | -0.10 puffs/day | Standard Deviation 0.79 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 4 (n= 13, 14, 26, 15) | -0.01 puffs/day | Standard Deviation 0.99 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 5 (n= 13, 14, 26, 15) | -0.22 puffs/day | Standard Deviation 1.39 |
| UK-432,097 450 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 6 (n= 13, 14, 24, 14) | 0.15 puffs/day | Standard Deviation 1.16 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 5 (n= 13, 14, 26, 15) | 0.21 puffs/day | Standard Deviation 1.32 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 2 (n= 13, 13, 27, 15) | -0.08 puffs/day | Standard Deviation 0.85 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 3 (n= 13, 14, 27, 15) | 0.03 puffs/day | Standard Deviation 0.95 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Baseline (n= 14, 15, 27, 15) | 2.97 puffs/day | Standard Deviation 2.83 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 4 (n= 13, 14, 26, 15) | -0.08 puffs/day | Standard Deviation 0.99 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 1 (n= 14, 15, 27, 15) | -0.19 puffs/day | Standard Deviation 0.61 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 6 (n= 13, 14, 24, 14) | 0.26 puffs/day | Standard Deviation 1.52 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 8 (n= 13, 13, 25, 14) | 0.30 puffs/day | Standard Deviation 1.47 |
| UK-432,097 1350 Mcg | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 7 (n= 13, 13, 26, 14) | 0.38 puffs/day | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Baseline (n= 14, 15, 27, 15) | 3.46 puffs/day | Standard Deviation 3.26 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 4 (n= 13, 14, 26, 15) | 0.07 puffs/day | Standard Deviation 1 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 2 (n= 13, 13, 27, 15) | 0.01 puffs/day | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 6 (n= 13, 14, 24, 14) | 0.30 puffs/day | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 5 (n= 13, 14, 26, 15) | 0.13 puffs/day | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 8 (n= 13, 13, 25, 14) | 0.40 puffs/day | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 3 (n= 13, 14, 27, 15) | 0.17 puffs/day | Standard Deviation 1.31 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 1 (n= 14, 15, 27, 15) | -0.41 puffs/day | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8 | Change at Week 7 (n= 13, 13, 26, 14) | 0.24 puffs/day | Standard Deviation 0.99 |
Comparison: Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.27Mixed Models Analysis
Comparison: Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1831Mixed Models Analysis
Comparison: Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1796Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8136Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6877Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6382Mixed Models Analysis
Comparison: Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.766Mixed Models Analysis
Comparison: Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7226Mixed Models Analysis
Comparison: Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6634Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7598Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.53Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7054Mixed Models Analysis
Comparison: Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8851Mixed Models Analysis
Comparison: Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7575Mixed Models Analysis
Comparison: Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4325Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8934Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5283Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.49Mixed Models Analysis
Comparison: Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7465Mixed Models Analysis
Comparison: Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5848Mixed Models Analysis
Comparison: Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3178Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8169Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6727Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5014Mixed Models Analysis
Secondary
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Time frame: Pre-dose at Baseline, Week 2, 4, 8
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.01 liter | Standard Deviation 0.1 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.03 liter | Standard Deviation 0.23 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.08 liter | Standard Deviation 0.19 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.10 liter | Standard Deviation 0.11 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | -0.07 liter | Standard Deviation 0.18 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.06 liter | Standard Deviation 0.15 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.02 liter | Standard Deviation 0.17 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | 0.01 liter | Standard Deviation 0.13 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.04 liter | Standard Deviation 0.23 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | 0.01 liter | Standard Deviation 0.18 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | -0.05 liter | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.01 liter | Standard Deviation 0.12 |
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5849Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9737Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.387Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8612Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7499Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5134Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1244Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.53Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.055Mixed Models Analysis
Secondary
Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.
Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.00 liter | Standard Deviation 0.25 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.02 liter | Standard Deviation 0.22 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.10 liter | Standard Deviation 0.34 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.12 liter | Standard Deviation 0.24 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.66 liter | Standard Deviation 0.73 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | 0.03 liter | Standard Deviation 0.19 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | 0.01 liter | Standard Deviation 0.3 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | -0.05 liter | Standard Deviation 0.31 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.08 liter | Standard Deviation 0.18 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.80 liter | Standard Deviation 0.81 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.05 liter | Standard Deviation 0.23 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.75 liter | Standard Deviation 0.69 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.01 liter | Standard Deviation 0.2 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.06 liter | Standard Deviation 0.22 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.04 liter | Standard Deviation 0.3 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.05 liter | Standard Deviation 0.18 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | 0.03 liter | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.54 liter | Standard Deviation 0.73 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.01 liter | Standard Deviation 0.13 |
| Placebo | Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | -0.09 liter | Standard Deviation 0.26 |
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7444Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9134Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6841Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9283Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2991Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7403Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3499Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2734Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5806Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.054Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2616Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.0724Mixed Models Analysis
Secondary
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.07 liter | Standard Deviation 0.3 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.14 liter | Standard Deviation 0.34 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.14 liter | Standard Deviation 0.46 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | 0.01 liter | Standard Deviation 0.32 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 3.11 liter | Standard Deviation 0.85 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.02 liter | Standard Deviation 0.4 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.09 liter | Standard Deviation 0.3 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 3.43 liter | Standard Deviation 1.16 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | 0.01 liter | Standard Deviation 0.33 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | 0.14 liter | Standard Deviation 0.21 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 3.24 liter | Standard Deviation 0.91 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.02 liter | Standard Deviation 0.32 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.07 liter | Standard Deviation 0.33 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.01 liter | Standard Deviation 0.31 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.04 liter | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | -0.05 liter | Standard Deviation 0.28 |
| Placebo | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | 0.05 liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | 0.02 liter | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | 0.09 liter | Standard Deviation 0.31 |
| Placebo | Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 3.01 liter | Standard Deviation 0.94 |
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9362Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9469Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9153Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.9686Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1548Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.7973Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6348Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.5742Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6719Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.0881Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2772Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1363Mixed Models Analysis
Secondary
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.
Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. Here 'n' signifies participants who were evaluable for this measure at specified time-point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.44 liter | Standard Deviation 0.63 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.07 liter | Standard Deviation 0.22 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.05 liter | Standard Deviation 0.18 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | 0.03 liter | Standard Deviation 0.27 |
| UK-432,097 150 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.03 liter | Standard Deviation 0.23 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.06 liter | Standard Deviation 0.38 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.03 liter | Standard Deviation 0.38 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | 0.01 liter | Standard Deviation 0.44 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.08 liter | Standard Deviation 0.4 |
| UK-432,097 450 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.81 liter | Standard Deviation 0.78 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.15 liter | Standard Deviation 0.28 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.14 liter | Standard Deviation 0.28 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.03 liter | Standard Deviation 0.3 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.53 liter | Standard Deviation 0.59 |
| UK-432,097 1350 Mcg | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | -0.10 liter | Standard Deviation 0.33 |
| Placebo | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 8 (n= 14, 16, 27, 16) | -0.05 liter | Standard Deviation 0.26 |
| Placebo | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Baseline (n= 16, 17, 32, 16) | 2.41 liter | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 4 (n= 15, 17, 30, 16) | -0.06 liter | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 6 (n= 14, 17, 29, 15) | -0.09 liter | Standard Deviation 0.32 |
| Placebo | Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8 | Change at Week 2 (n= 16, 17, 32, 16) | -0.10 liter | Standard Deviation 0.24 |
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6113Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.0938Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2149Mixed Models Analysis
Comparison: Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1682Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.4492Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.2539Mixed Models Analysis
Comparison: Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.8168Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3248Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.3148Mixed Models Analysis
Comparison: Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.6563Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1735Mixed Models Analysis
Comparison: Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.p-value: 0.1237Mixed Models Analysis
Secondary
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Week 6
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Improved | 5 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | No Change | 5 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Worse | 0 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Worse | 2 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Worse | 2 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Improved | 0 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Improved | 0 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Worse | 3 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | No Change | 7 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Improved | 0 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Worse | 0 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Improved | 4 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Worse | 0 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Improved | 2 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Worse | 0 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Worse | 4 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Improved | 9 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Improved | 2 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | No Change | 14 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Improved | 0 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Worse | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Worse | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | No Change | 6 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Worse | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Very Much Improved | 1 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Improved | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Much Worse | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C) | Minimally Improved | 4 participants |
Comparison: A proportional odds model was fitted using Proc Logistic in Statistical Analysis System (SAS), using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.95% CI: [0.2023, 2.0419]
Comparison: A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.95% CI: [0.1505, 2.0647]
Comparison: A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.95% CI: [0.083, 1.2879]
Secondary
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time frame: Week 6
Population: FAS: all randomized participants, who received at least 2 weeks of dosing and had at least 1 valid FEV1 measurement during treatment. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Worse | 1 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Worse | 0 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Improved | 3 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | No Change | 7 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Improved | 0 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Worse | 1 participants |
| UK-432,097 150 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Improved | 2 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Improved | 2 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Improved | 0 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Worse | 1 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Improved | 4 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | No Change | 8 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Worse | 0 participants |
| UK-432,097 450 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Worse | 1 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Improved | 3 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Worse | 1 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Worse | 1 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | No Change | 15 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Improved | 7 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Improved | 0 participants |
| UK-432,097 1350 Mcg | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Worse | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Worse | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Very Much Improved | 0 participants |
| Placebo | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Improved | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Improved | 6 participants |
| Placebo | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | No Change | 5 participants |
| Placebo | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Minimally Worse | 2 participants |
| Placebo | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C) | Much Worse | 0 participants |
Comparison: A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.95% CI: [0.179, 1.8204]
Comparison: A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.95% CI: [0.1736, 2.3715]
Comparison: A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.95% CI: [0.1516, 2.2777]
Other Pre-specified
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8
Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.
Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here n signifies participants who were evaluable for specified time-point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Post-Dose (n= 15,16,28,15) | 1.9 bpm | Standard Deviation 8.68 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Pre-Dose (n= 14,16,29,15) | 2.3 bpm | Standard Deviation 5.17 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 0, Post-Dose (n= 17,18,35,17) | 0.8 bpm | Standard Deviation 6.56 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 8 (n= 17,18,32,17) | 1.9 bpm | Standard Deviation 5.94 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 1, Post-Dose (n= 17,17,32,16) | 1.1 bpm | Standard Deviation 9.76 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 2, Post-Dose (n= 16,17,32,16) | 0.7 bpm | Standard Deviation 8.98 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Baseline (n= 17,18,35,17) | 66.6 bpm | Standard Deviation 11.65 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 4, Post-Dose (n= 15,17,29,16) | -0.2 bpm | Standard Deviation 8.75 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 2, Post-Dose (n= 16,17,32,16) | 4.2 bpm | Standard Deviation 10.38 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 4, Post-Dose (n= 15,17,29,16) | 2.4 bpm | Standard Deviation 8.33 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 8 (n= 17,18,32,17) | 1.8 bpm | Standard Deviation 6.51 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Pre-Dose (n= 14,16,29,15) | 1.4 bpm | Standard Deviation 7.71 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 1, Post-Dose (n= 17,17,32,16) | 4.3 bpm | Standard Deviation 6.3 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Baseline (n= 17,18,35,17) | 72.1 bpm | Standard Deviation 11 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 0, Post-Dose (n= 17,18,35,17) | 4.0 bpm | Standard Deviation 5.9 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Post-Dose (n= 15,16,28,15) | 2.2 bpm | Standard Deviation 6.94 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 0, Post-Dose (n= 17,18,35,17) | 0.3 bpm | Standard Deviation 8.69 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Baseline (n= 17,18,35,17) | 74.8 bpm | Standard Deviation 12.92 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 1, Post-Dose (n= 17,17,32,16) | -1.5 bpm | Standard Deviation 10.13 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 2, Post-Dose (n= 16,17,32,16) | -0.2 bpm | Standard Deviation 12.76 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 4, Post-Dose (n= 15,17,29,16) | 2.5 bpm | Standard Deviation 18.51 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Pre-Dose (n= 14,16,29,15) | 0.6 bpm | Standard Deviation 11.82 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Post-Dose (n= 15,16,28,15) | 2.6 bpm | Standard Deviation 11.84 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 8 (n= 17,18,32,17) | -0.8 bpm | Standard Deviation 11.16 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 2, Post-Dose (n= 16,17,32,16) | 1.9 bpm | Standard Deviation 8.06 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 1, Post-Dose (n= 17,17,32,16) | 2.8 bpm | Standard Deviation 13.45 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 8 (n= 17,18,32,17) | -2.1 bpm | Standard Deviation 9.57 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Post-Dose (n= 15,16,28,15) | 0.3 bpm | Standard Deviation 11.31 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 0, Post-Dose (n= 17,18,35,17) | 2.7 bpm | Standard Deviation 7.76 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 4, Post-Dose (n= 15,17,29,16) | 3.2 bpm | Standard Deviation 8.23 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Baseline (n= 17,18,35,17) | 72.4 bpm | Standard Deviation 13.81 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8 | Change at Week 6, Pre-Dose (n= 14,16,29,15) | -1.7 bpm | Standard Deviation 7.72 |
Other Pre-specified
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8
Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia's formula (QTcF=QT divided by cube root of RR Int) and Bazett's formula (QTcB=QT divided by square root of RR Int).
Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here n signifies participants who were evaluable for specified time-point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Baseline (n= 17,18,34,17) | 747.0 milliseconds (msec) | Standard Deviation 351.66 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 2, Post-Dose (n= 16,17,32,16) | 1.6 milliseconds (msec) | Standard Deviation 14.3 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 0, Post-Dose (n= 17,18,34,17) | 34.4 milliseconds (msec) | Standard Deviation 174.39 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 8 (n= 17,18,32,17) | 9.4 milliseconds (msec) | Standard Deviation 24.35 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 1, Post-Dose (n= 17,17,32,16) | 2.0 milliseconds (msec) | Standard Deviation 12.43 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 0, Post-Dose (n= 17,18,35,17) | -0.7 milliseconds (msec) | Standard Deviation 6.85 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 1, Post-Dose (n= 17,17,31,16) | 45.8 milliseconds (msec) | Standard Deviation 250.92 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 8 (n= 17,18,32,17) | 11.6 milliseconds (msec) | Standard Deviation 24.91 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 2, Post-Dose (n= 16,17,31,16) | -18.5 milliseconds (msec) | Standard Deviation 111.03 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Post-Dose (n= 15,16,28,15) | 15.2 milliseconds (msec) | Standard Deviation 13.76 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Baseline (n= 17,18,35,17) | 165.6 milliseconds (msec) | Standard Deviation 23.91 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 8 (n= 17,18,32,17) | 0.5 milliseconds (msec) | Standard Deviation 5.58 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 8 (n= 17,18,31,17) | -10.4 milliseconds (msec) | Standard Deviation 85.52 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Pre-Dose (n= 14,16,28,15) | -19.3 milliseconds (msec) | Standard Deviation 72.8 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Post-Dose (n= 15,16,28,15) | 13.2 milliseconds (msec) | Standard Deviation 17.11 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Post-Dose (n= 15,16,27,15) | -22.9 milliseconds (msec) | Standard Deviation 109.2 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 13.0 milliseconds (msec) | Standard Deviation 14.92 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Baseline (n= 17,18,35,17) | 387.9 milliseconds (msec) | Standard Deviation 27.09 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Baseline (n= 17,18,35,17) | 405.7 milliseconds (msec) | Standard Deviation 27.46 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 0, Post-Dose (n= 17,18,35,17) | 6.9 milliseconds (msec) | Standard Deviation 11 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 10.9 milliseconds (msec) | Standard Deviation 16.11 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Baseline (n= 17,18,35,17) | 401.1 milliseconds (msec) | Standard Deviation 22.91 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 12.4 milliseconds (msec) | Standard Deviation 16.86 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 1, Post-Dose (n= 17,17,32,16) | -1.8 milliseconds (msec) | Standard Deviation 27.75 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 4, Post-Dose (n= 15,17,29,16) | -0.4 milliseconds (msec) | Standard Deviation 21.21 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Post-Dose (n= 15,16,28,15) | 9.7 milliseconds (msec) | Standard Deviation 30 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 6.6 milliseconds (msec) | Standard Deviation 21.85 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 8 (n= 17,18,32,17) | 5.3 milliseconds (msec) | Standard Deviation 26.56 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 4, Post-Dose (n= 15,17,29,16) | 0.2 milliseconds (msec) | Standard Deviation 25.61 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 2, Post-Dose (n= 16,17,32,16) | 15.4 milliseconds (msec) | Standard Deviation 66.03 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 0, Post-Dose (n= 17,18,35,17) | 3.2 milliseconds (msec) | Standard Deviation 16.81 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 2.2 milliseconds (msec) | Standard Deviation 5.3 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 1, Post-Dose (n= 17,17,32,16) | -2.1 milliseconds (msec) | Standard Deviation 22.79 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 4, Post-Dose (n= 15,17,29,16) | -0.2 milliseconds (msec) | Standard Deviation 5.95 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 2, Post-Dose (n= 16,17,32,16) | 18.5 milliseconds (msec) | Standard Deviation 58.27 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 4, Post-Dose (n= 15,17,28,16) | 98.1 milliseconds (msec) | Standard Deviation 291.65 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 4, Post-Dose (n= 15,17,29,16) | 1.6 milliseconds (msec) | Standard Deviation 20.58 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 2, Post-Dose (n= 16,17,32,16) | 16.9 milliseconds (msec) | Standard Deviation 58.63 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Post-Dose (n= 15,16,28,15) | -1.5 milliseconds (msec) | Standard Deviation 14.85 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -2.4 milliseconds (msec) | Standard Deviation 10.11 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 1, Post-Dose (n= 17,17,32,16) | -0.1 milliseconds (msec) | Standard Deviation 16.61 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 4, Post-Dose (n= 15,17,29,16) | 2.8 milliseconds (msec) | Standard Deviation 11.81 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Post-Dose (n= 15,16,28,15) | 15.0 milliseconds (msec) | Standard Deviation 15.87 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 2, Post-Dose (n= 16,17,32,16) | -0.2 milliseconds (msec) | Standard Deviation 6.92 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 8 (n= 17,18,32,17) | 11.5 milliseconds (msec) | Standard Deviation 23.83 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 1, Post-Dose (n= 17,17,32,16) | -1.7 milliseconds (msec) | Standard Deviation 12.3 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Baseline (n= 17,18,35,17) | 399.4 milliseconds (msec) | Standard Deviation 22.33 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 0, Post-Dose (n= 17,18,35,17) | -0.4 milliseconds (msec) | Standard Deviation 4.49 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Baseline (n= 17,18,35,17) | 93.2 milliseconds (msec) | Standard Deviation 10.58 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 0, Post-Dose (n= 17,18,35,17) | 6.7 milliseconds (msec) | Standard Deviation 11.69 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 1, Post-Dose (n= 17,17,32,16) | 0.9 milliseconds (msec) | Standard Deviation 16.06 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 2, Post-Dose (n= 16,17,32,16) | 17.9 milliseconds (msec) | Standard Deviation 56.34 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 8 (n= 17,18,32,17) | -4.9 milliseconds (msec) | Standard Deviation 16.05 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 4, Post-Dose (n= 15,17,29,16) | -0.7 milliseconds (msec) | Standard Deviation 24.27 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 0, Post-Dose (n= 17,18,35,17) | 5.5 milliseconds (msec) | Standard Deviation 10.29 |
| UK-432,097 150 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Post-Dose (n= 15,16,28,15) | 3.4 milliseconds (msec) | Standard Deviation 6 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 4, Post-Dose (n= 15,17,29,16) | -3.9 milliseconds (msec) | Standard Deviation 19.91 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Post-Dose (n= 15,16,28,15) | -1.4 milliseconds (msec) | Standard Deviation 9.7 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 8 (n= 17,18,32,17) | 0.8 milliseconds (msec) | Standard Deviation 3.88 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 0, Post-Dose (n= 17,18,35,17) | -5.1 milliseconds (msec) | Standard Deviation 10.9 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 1, Post-Dose (n= 17,17,32,16) | -12.5 milliseconds (msec) | Standard Deviation 16.61 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 2, Post-Dose (n= 16,17,32,16) | 4.8 milliseconds (msec) | Standard Deviation 19.04 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 4, Post-Dose (n= 15,17,29,16) | 5.5 milliseconds (msec) | Standard Deviation 18.94 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -0.4 milliseconds (msec) | Standard Deviation 9.68 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Post-Dose (n= 15,16,28,15) | 5.4 milliseconds (msec) | Standard Deviation 16.94 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Baseline (n= 17,18,35,17) | 417.2 milliseconds (msec) | Standard Deviation 18.69 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 0, Post-Dose (n= 17,18,35,17) | 2.8 milliseconds (msec) | Standard Deviation 9.3 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 0, Post-Dose (n= 17,18,34,17) | -63.7 milliseconds (msec) | Standard Deviation 82.96 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 1, Post-Dose (n= 17,17,31,16) | -62.8 milliseconds (msec) | Standard Deviation 82.17 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 2, Post-Dose (n= 16,17,31,16) | -49.1 milliseconds (msec) | Standard Deviation 131.1 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 4, Post-Dose (n= 15,17,28,16) | -88.7 milliseconds (msec) | Standard Deviation 194.5 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Pre-Dose (n= 14,16,28,15) | -32.3 milliseconds (msec) | Standard Deviation 84.2 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Post-Dose (n= 15,16,27,15) | -43.7 milliseconds (msec) | Standard Deviation 99.03 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 8 (n= 17,18,31,17) | -36.4 milliseconds (msec) | Standard Deviation 83.34 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Post-Dose (n= 15,16,28,15) | 1.9 milliseconds (msec) | Standard Deviation 14.63 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Baseline (n= 17,18,35,17) | 165.0 milliseconds (msec) | Standard Deviation 23.03 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 0, Post-Dose (n= 17,18,35,17) | -1.3 milliseconds (msec) | Standard Deviation 8.51 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 1, Post-Dose (n= 17,17,32,16) | -0.6 milliseconds (msec) | Standard Deviation 13.79 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 8 (n= 17,18,32,17) | -2.2 milliseconds (msec) | Standard Deviation 13.17 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Baseline (n= 17,18,35,17) | 89.1 milliseconds (msec) | Standard Deviation 11.4 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 0, Post-Dose (n= 17,18,35,17) | 0.9 milliseconds (msec) | Standard Deviation 3.31 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 1, Post-Dose (n= 17,17,32,16) | -0.6 milliseconds (msec) | Standard Deviation 5.7 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 2, Post-Dose (n= 16,17,32,16) | 2.3 milliseconds (msec) | Standard Deviation 4.96 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 2, Post-Dose (n= 16,17,32,16) | 1.1 milliseconds (msec) | Standard Deviation 13.33 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 4, Post-Dose (n= 15,17,29,16) | -2.5 milliseconds (msec) | Standard Deviation 11.93 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 2.4 milliseconds (msec) | Standard Deviation 12.85 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 4, Post-Dose (n= 15,17,29,16) | -0.7 milliseconds (msec) | Standard Deviation 9.4 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -1.4 milliseconds (msec) | Standard Deviation 7.54 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Baseline (n= 17,18,35,17) | 384.0 milliseconds (msec) | Standard Deviation 37.04 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 2, Post-Dose (n= 16,17,32,16) | -5.1 milliseconds (msec) | Standard Deviation 18.91 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Baseline (n= 17,18,34,17) | 696.1 milliseconds (msec) | Standard Deviation 357.91 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -5.0 milliseconds (msec) | Standard Deviation 16.06 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 8 (n= 17,18,32,17) | -6.8 milliseconds (msec) | Standard Deviation 20.08 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Post-Dose (n= 15,16,28,15) | -3.6 milliseconds (msec) | Standard Deviation 17.51 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Baseline (n= 17,18,35,17) | 409.6 milliseconds (msec) | Standard Deviation 20.7 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 0, Post-Dose (n= 17,18,35,17) | 7.1 milliseconds (msec) | Standard Deviation 14.01 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 1, Post-Dose (n= 17,17,32,16) | -0.3 milliseconds (msec) | Standard Deviation 14.53 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 2, Post-Dose (n= 16,17,32,16) | 7.6 milliseconds (msec) | Standard Deviation 16.39 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 8 (n= 17,18,32,17) | 0.1 milliseconds (msec) | Standard Deviation 10.34 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 0, Post-Dose (n= 17,18,35,17) | 6.8 milliseconds (msec) | Standard Deviation 12.56 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 1, Post-Dose (n= 17,17,32,16) | -0.0 milliseconds (msec) | Standard Deviation 10.52 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -1.0 milliseconds (msec) | Standard Deviation 12.81 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Post-Dose (n= 15,16,28,15) | 3.8 milliseconds (msec) | Standard Deviation 16.69 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 8 (n= 17,18,32,17) | -1.2 milliseconds (msec) | Standard Deviation 10.21 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 4, Post-Dose (n= 15,17,29,16) | 4.0 milliseconds (msec) | Standard Deviation 13.95 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Baseline (n= 17,18,35,17) | 405.4 milliseconds (msec) | Standard Deviation 22.06 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 1, Post-Dose (n= 17,17,32,16) | -4.5 milliseconds (msec) | Standard Deviation 12.73 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 2, Post-Dose (n= 16,17,32,16) | 3.1 milliseconds (msec) | Standard Deviation 11.21 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 4, Post-Dose (n= 15,17,29,16) | 1.3 milliseconds (msec) | Standard Deviation 12.14 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -2.4 milliseconds (msec) | Standard Deviation 9.75 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Post-Dose (n= 15,16,28,15) | 1.3 milliseconds (msec) | Standard Deviation 14.15 |
| UK-432,097 450 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 8 (n= 17,18,32,17) | -3.0 milliseconds (msec) | Standard Deviation 10.38 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 4, Post-Dose (n= 15,17,29,16) | 9.4 milliseconds (msec) | Standard Deviation 27.88 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 8 (n= 17,18,32,17) | 9.1 milliseconds (msec) | Standard Deviation 25.3 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Baseline (n= 17,18,35,17) | 371.9 milliseconds (msec) | Standard Deviation 27.52 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -2.1 milliseconds (msec) | Standard Deviation 10.59 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 0, Post-Dose (n= 17,18,35,17) | 7.2 milliseconds (msec) | Standard Deviation 21.29 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 1, Post-Dose (n= 17,17,32,16) | 5.2 milliseconds (msec) | Standard Deviation 20.6 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 8.5 milliseconds (msec) | Standard Deviation 22.91 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 1, Post-Dose (n= 17,17,32,16) | 3.3 milliseconds (msec) | Standard Deviation 23.46 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 2, Post-Dose (n= 16,17,32,16) | 3.0 milliseconds (msec) | Standard Deviation 21.77 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 4, Post-Dose (n= 15,17,29,16) | 9.4 milliseconds (msec) | Standard Deviation 26.13 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 2, Post-Dose (n= 16,17,32,16) | 4.1 milliseconds (msec) | Standard Deviation 23.21 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 4, Post-Dose (n= 15,17,29,16) | 11.3 milliseconds (msec) | Standard Deviation 29.54 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 2, Post-Dose (n= 16,17,32,16) | 3.4 milliseconds (msec) | Standard Deviation 28.34 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Baseline (n= 17,18,35,17) | 397.8 milliseconds (msec) | Standard Deviation 20.9 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 4, Post-Dose (n= 15,17,29,16) | 6.5 milliseconds (msec) | Standard Deviation 49.74 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 10.0 milliseconds (msec) | Standard Deviation 24 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 4, Post-Dose (n= 15,17,28,16) | -6.6 milliseconds (msec) | Standard Deviation 144.2 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Pre-Dose (n= 14,16,28,15) | -1.6 milliseconds (msec) | Standard Deviation 101 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 8 (n= 17,18,32,17) | 11.3 milliseconds (msec) | Standard Deviation 23.65 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Post-Dose (n= 15,16,27,15) | -27.3 milliseconds (msec) | Standard Deviation 124.2 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 6.3 milliseconds (msec) | Standard Deviation 25.4 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 0, Post-Dose (n= 17,18,35,17) | 6.7 milliseconds (msec) | Standard Deviation 19.1 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 1, Post-Dose (n= 17,17,32,16) | 6.4 milliseconds (msec) | Standard Deviation 23.75 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 8 (n= 17,18,31,17) | -1.1 milliseconds (msec) | Standard Deviation 185.33 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 4, Post-Dose (n= 15,17,29,16) | -0.9 milliseconds (msec) | Standard Deviation 6.3 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 8 (n= 17,18,32,17) | 10.9 milliseconds (msec) | Standard Deviation 23.31 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 8.8 milliseconds (msec) | Standard Deviation 20.37 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Post-Dose (n= 15,16,28,15) | -3.0 milliseconds (msec) | Standard Deviation 13.56 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Post-Dose (n= 15,16,28,15) | 5.0 milliseconds (msec) | Standard Deviation 30.17 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Post-Dose (n= 15,16,28,15) | 13.9 milliseconds (msec) | Standard Deviation 23.88 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Baseline (n= 17,18,35,17) | 171.2 milliseconds (msec) | Standard Deviation 26.92 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 2, Post-Dose (n= 16,17,32,16) | -4.1 milliseconds (msec) | Standard Deviation 11.34 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 2, Post-Dose (n= 16,17,32,16) | -2.6 milliseconds (msec) | Standard Deviation 8.15 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 0, Post-Dose (n= 17,18,35,17) | 5.6 milliseconds (msec) | Standard Deviation 22.76 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 0, Post-Dose (n= 17,18,35,17) | -2.4 milliseconds (msec) | Standard Deviation 8.59 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 2, Post-Dose (n= 16,17,32,16) | 4.1 milliseconds (msec) | Standard Deviation 20.59 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 0, Post-Dose (n= 17,18,34,17) | -2.0 milliseconds (msec) | Standard Deviation 100.92 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Post-Dose (n= 15,16,28,15) | -1.3 milliseconds (msec) | Standard Deviation 5.94 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 1, Post-Dose (n= 17,17,32,16) | 2.0 milliseconds (msec) | Standard Deviation 19.93 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -2.5 milliseconds (msec) | Standard Deviation 7.37 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Baseline (n= 17,18,34,17) | 733.3 milliseconds (msec) | Standard Deviation 281.12 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 8 (n= 17,18,32,17) | 0.1 milliseconds (msec) | Standard Deviation 8.09 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 0, Post-Dose (n= 17,18,35,17) | -1.0 milliseconds (msec) | Standard Deviation 5.52 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 8 (n= 17,18,32,17) | -3.6 milliseconds (msec) | Standard Deviation 13.71 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 0, Post-Dose (n= 17,18,35,17) | 7.1 milliseconds (msec) | Standard Deviation 20.17 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 2, Post-Dose (n= 16,17,31,16) | 12.0 milliseconds (msec) | Standard Deviation 120 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 1, Post-Dose (n= 17,17,31,16) | 7.3 milliseconds (msec) | Standard Deviation 112.16 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Baseline (n= 17,18,35,17) | 85.8 milliseconds (msec) | Standard Deviation 26.19 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 1, Post-Dose (n= 17,17,32,16) | 4.2 milliseconds (msec) | Standard Deviation 24.27 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Baseline (n= 17,18,35,17) | 412.0 milliseconds (msec) | Standard Deviation 25.85 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 8 (n= 17,18,32,17) | 10.7 milliseconds (msec) | Standard Deviation 28.23 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Baseline (n= 17,18,35,17) | 409.2 milliseconds (msec) | Standard Deviation 25.92 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 4, Post-Dose (n= 15,17,29,16) | 6.5 milliseconds (msec) | Standard Deviation 36.69 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Post-Dose (n= 15,16,28,15) | 10.6 milliseconds (msec) | Standard Deviation 24.11 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 1, Post-Dose (n= 17,17,32,16) | -1.7 milliseconds (msec) | Standard Deviation 6.11 |
| UK-432,097 1350 Mcg | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Post-Dose (n= 15,16,28,15) | 10.9 milliseconds (msec) | Standard Deviation 22.53 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 1, Post-Dose (n= 17,17,32,16) | 5.6 milliseconds (msec) | Standard Deviation 28.56 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 2, Post-Dose (n= 16,17,32,16) | 6.4 milliseconds (msec) | Standard Deviation 40.37 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 4, Post-Dose (n= 15,17,29,16) | 9.2 milliseconds (msec) | Standard Deviation 37.48 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 4, Post-Dose (n= 15,17,29,16) | 3.8 milliseconds (msec) | Standard Deviation 23.36 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Baseline (n= 17,18,35,17) | 402.3 milliseconds (msec) | Standard Deviation 20.33 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 0.2 milliseconds (msec) | Standard Deviation 26.08 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 2, Post-Dose (n= 16,17,32,16) | -4.6 milliseconds (msec) | Standard Deviation 9.82 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 1, Post-Dose (n= 17,17,32,16) | 3.5 milliseconds (msec) | Standard Deviation 10.63 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 4, Post-Dose (n= 15,17,29,16) | -2.2 milliseconds (msec) | Standard Deviation 12.45 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 0, Post-Dose (n= 17,18,35,17) | 4.3 milliseconds (msec) | Standard Deviation 14.15 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 0, Post-Dose (n= 17,18,35,17) | 6.8 milliseconds (msec) | Standard Deviation 15.06 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 2, Post-Dose (n= 16,17,32,16) | 2.0 milliseconds (msec) | Standard Deviation 26.65 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 4, Post-Dose (n= 15,17,29,16) | -1.6 milliseconds (msec) | Standard Deviation 29.41 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Post-Dose (n= 15,16,28,15) | 3.4 milliseconds (msec) | Standard Deviation 28.95 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 1, Post-Dose (n= 17,17,32,16) | 1.6 milliseconds (msec) | Standard Deviation 29.1 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 1, Post-Dose (n= 17,17,32,16) | 5.4 milliseconds (msec) | Standard Deviation 15.26 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 6, Pre-Dose (n= 14,16,29,15) | 2.6 milliseconds (msec) | Standard Deviation 22.65 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Post-Dose (n= 15,16,28,15) | 3.1 milliseconds (msec) | Standard Deviation 14.58 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 8 (n= 17,18,32,17) | -0.5 milliseconds (msec) | Standard Deviation 18.66 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Change at Week 0, Post-Dose (n= 17,18,35,17) | 1.4 milliseconds (msec) | Standard Deviation 22.92 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -4.7 milliseconds (msec) | Standard Deviation 16.79 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Baseline (n= 17,18,35,17) | 410.8 milliseconds (msec) | Standard Deviation 20.63 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QT: Baseline (n= 17,18,35,17) | 381.7 milliseconds (msec) | Standard Deviation 40.08 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 2, Post-Dose (n= 16,17,32,16) | 6.2 milliseconds (msec) | Standard Deviation 18.85 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 1, Post-Dose (n= 17,17,32,16) | 7.8 milliseconds (msec) | Standard Deviation 17.5 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Baseline (n= 17,18,34,17) | 745.7 milliseconds (msec) | Standard Deviation 362.9 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 6, Post-Dose (n= 15,16,28,15) | -1.6 milliseconds (msec) | Standard Deviation 20.1 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 4, Post-Dose (n= 15,17,29,16) | 5.6 milliseconds (msec) | Standard Deviation 20.76 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 0, Post-Dose (n= 17,18,35,17) | 9.8 milliseconds (msec) | Standard Deviation 14.48 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 1, Post-Dose (n= 17,17,31,16) | 6.0 milliseconds (msec) | Standard Deviation 113.17 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 2, Post-Dose (n= 16,17,32,16) | 5.8 milliseconds (msec) | Standard Deviation 22.96 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 4, Post-Dose (n= 15,17,29,16) | 9.2 milliseconds (msec) | Standard Deviation 18.59 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 8 (n= 17,18,32,17) | -4.0 milliseconds (msec) | Standard Deviation 9.02 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 8 (n= 17,18,32,17) | -4.3 milliseconds (msec) | Standard Deviation 10 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Pre-Dose (n= 14,16,28,15) | -24.6 milliseconds (msec) | Standard Deviation 206.21 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -1.5 milliseconds (msec) | Standard Deviation 12.18 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 6, Post-Dose (n= 15,16,27,15) | -34.9 milliseconds (msec) | Standard Deviation 233.38 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 4, Post-Dose (n= 15,17,28,16) | -66.0 milliseconds (msec) | Standard Deviation 196.32 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Post-Dose (n= 15,16,28,15) | -4.3 milliseconds (msec) | Standard Deviation 10.86 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 8 (n= 17,18,31,17) | -19.3 milliseconds (msec) | Standard Deviation 200.12 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 2, Post-Dose (n= 16,17,31,16) | -78.6 milliseconds (msec) | Standard Deviation 202.34 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 6, Post-Dose (n= 15,16,28,15) | 4.4 milliseconds (msec) | Standard Deviation 29.21 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Baseline (n= 17,18,35,17) | 172.8 milliseconds (msec) | Standard Deviation 23.89 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | RR: Change at Week 0, Post-Dose (n= 17,18,34,17) | -6.1 milliseconds (msec) | Standard Deviation 93.51 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 6, Post-Dose (n= 15,16,28,15) | 3.0 milliseconds (msec) | Standard Deviation 11.68 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 0, Post-Dose (n= 17,18,35,17) | 0.8 milliseconds (msec) | Standard Deviation 16.21 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 1, Post-Dose (n= 17,17,32,16) | 0.2 milliseconds (msec) | Standard Deviation 22.78 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 2, Post-Dose (n= 16,17,32,16) | 8.5 milliseconds (msec) | Standard Deviation 18.05 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcF: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -0.0 milliseconds (msec) | Standard Deviation 13.67 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | PR: Change at Week 8 (n= 17,18,32,17) | -0.4 milliseconds (msec) | Standard Deviation 16.64 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Baseline (n= 17,18,35,17) | 413.6 milliseconds (msec) | Standard Deviation 18.26 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Baseline (n= 17,18,35,17) | 92.7 milliseconds (msec) | Standard Deviation 14.93 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 0, Post-Dose (n= 17,18,35,17) | -2.1 milliseconds (msec) | Standard Deviation 9.82 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTc: Change at Week 8 (n= 17,18,32,17) | -8.8 milliseconds (msec) | Standard Deviation 15 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QTcB: Change at Week 8 (n= 17,18,32,17) | -6.2 milliseconds (msec) | Standard Deviation 13.54 |
| Placebo | Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8 | QRS: Change at Week 6, Pre-Dose (n= 14,16,29,15) | -4.2 milliseconds (msec) | Standard Deviation 10.91 |
Other Pre-specified
Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.
Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here n signifies participants who were evaluable for specified time-point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Baseline (n= 17, 18, 35, 17) | 76.9 millimeter of mercury (mmHg) | Standard Deviation 7.18 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | 1.4 millimeter of mercury (mmHg) | Standard Deviation 16.25 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Baseline (n= 17, 18, 35, 17) | 128.5 millimeter of mercury (mmHg) | Standard Deviation 11.73 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | -1.8 millimeter of mercury (mmHg) | Standard Deviation 7.53 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | -2.2 millimeter of mercury (mmHg) | Standard Deviation 6.28 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | -1.9 millimeter of mercury (mmHg) | Standard Deviation 9.86 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | 2.4 millimeter of mercury (mmHg) | Standard Deviation 7.29 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | 0.5 millimeter of mercury (mmHg) | Standard Deviation 9.9 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | 3.6 millimeter of mercury (mmHg) | Standard Deviation 11.57 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | 1.1 millimeter of mercury (mmHg) | Standard Deviation 10.56 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | 1.4 millimeter of mercury (mmHg) | Standard Deviation 6.33 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | 0.1 millimeter of mercury (mmHg) | Standard Deviation 5.97 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | 3.1 millimeter of mercury (mmHg) | Standard Deviation 6.27 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | -0.6 millimeter of mercury (mmHg) | Standard Deviation 11.28 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -5.2 millimeter of mercury (mmHg) | Standard Deviation 6.9 |
| UK-432,097 150 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -1.2 millimeter of mercury (mmHg) | Standard Deviation 10.14 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | -2.1 millimeter of mercury (mmHg) | Standard Deviation 8.72 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | -5.5 millimeter of mercury (mmHg) | Standard Deviation 16.17 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | -2.0 millimeter of mercury (mmHg) | Standard Deviation 6.21 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -7.5 millimeter of mercury (mmHg) | Standard Deviation 13.73 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | 2.8 millimeter of mercury (mmHg) | Standard Deviation 16.64 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -7.3 millimeter of mercury (mmHg) | Standard Deviation 7.88 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | -4.5 millimeter of mercury (mmHg) | Standard Deviation 6.49 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | 0.1 millimeter of mercury (mmHg) | Standard Deviation 7.96 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | -3.9 millimeter of mercury (mmHg) | Standard Deviation 8.21 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Baseline (n= 17, 18, 35, 17) | 78.5 millimeter of mercury (mmHg) | Standard Deviation 10.29 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | -7.6 millimeter of mercury (mmHg) | Standard Deviation 15.19 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Baseline (n= 17, 18, 35, 17) | 137.3 millimeter of mercury (mmHg) | Standard Deviation 14.4 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | -1.3 millimeter of mercury (mmHg) | Standard Deviation 11.52 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | -0.8 millimeter of mercury (mmHg) | Standard Deviation 6.18 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | -4.7 millimeter of mercury (mmHg) | Standard Deviation 12.96 |
| UK-432,097 450 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | -1.4 millimeter of mercury (mmHg) | Standard Deviation 15.34 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | -1.3 millimeter of mercury (mmHg) | Standard Deviation 9.7 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | -1.5 millimeter of mercury (mmHg) | Standard Deviation 9.54 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | -0.7 millimeter of mercury (mmHg) | Standard Deviation 6.3 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | -0.1 millimeter of mercury (mmHg) | Standard Deviation 8.68 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | -0.2 millimeter of mercury (mmHg) | Standard Deviation 8.95 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | 0.5 millimeter of mercury (mmHg) | Standard Deviation 13.06 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Baseline (n= 17, 18, 35, 17) | 129.5 millimeter of mercury (mmHg) | Standard Deviation 12.77 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | -1.3 millimeter of mercury (mmHg) | Standard Deviation 14.56 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | 0.7 millimeter of mercury (mmHg) | Standard Deviation 12.32 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | 1.0 millimeter of mercury (mmHg) | Standard Deviation 15.41 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | -0.3 millimeter of mercury (mmHg) | Standard Deviation 6.74 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -2.8 millimeter of mercury (mmHg) | Standard Deviation 6.87 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -0.9 millimeter of mercury (mmHg) | Standard Deviation 8.77 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Baseline (n= 17, 18, 35, 17) | 74.3 millimeter of mercury (mmHg) | Standard Deviation 8.3 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | -0.5 millimeter of mercury (mmHg) | Standard Deviation 8.07 |
| UK-432,097 1350 Mcg | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | -1.9 millimeter of mercury (mmHg) | Standard Deviation 8.1 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | -4.5 millimeter of mercury (mmHg) | Standard Deviation 12.81 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | 0.3 millimeter of mercury (mmHg) | Standard Deviation 11.98 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | 0.1 millimeter of mercury (mmHg) | Standard Deviation 7.64 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Baseline (n= 17, 18, 35, 17) | 76.5 millimeter of mercury (mmHg) | Standard Deviation 7.24 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 2, Post-Dose (n= 16,17,30,16) | -2.2 millimeter of mercury (mmHg) | Standard Deviation 14.86 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | 0.4 millimeter of mercury (mmHg) | Standard Deviation 7.36 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Pre-Dose (n= 15,18,33,16) | 1.5 millimeter of mercury (mmHg) | Standard Deviation 6.23 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Baseline (n= 17, 18, 35, 17) | 132.7 millimeter of mercury (mmHg) | Standard Deviation 13.45 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -3.5 millimeter of mercury (mmHg) | Standard Deviation 8.27 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 1, Post-Dose (n= 17,15,32,16) | -1.0 millimeter of mercury (mmHg) | Standard Deviation 7.41 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | 0.7 millimeter of mercury (mmHg) | Standard Deviation 5.09 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | -1.2 millimeter of mercury (mmHg) | Standard Deviation 7.79 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Pre-Dose (n= 15,16,28,15) | 1.2 millimeter of mercury (mmHg) | Standard Deviation 10.81 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 4, Post-Dose (n= 15,15,30,16) | -5.8 millimeter of mercury (mmHg) | Standard Deviation 15.21 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | DBP: Change at Week 0, Post-Dose (n= 16,18,35,17) | 0.6 millimeter of mercury (mmHg) | Standard Deviation 6.44 |
| Placebo | Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6 | SBP: Change at Week 6, Post-Dose (n= 14,16,28,15) | -0.9 millimeter of mercury (mmHg) | Standard Deviation 12.68 |
Other Pre-specified
Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).
Time frame: Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4
Population: Safety analysis set included all participants who received at least 1 dose of study treatment. Here n signifies participants who were evaluable for specified time-point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Baseline (n= 17, 18, 35, 17) | 68.6 bpm | Standard Deviation 11.45 |
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 0, Post-Dose (n= 16, 18, 35, 17) | -0.4 bpm | Standard Deviation 6.86 |
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Pre-Dose (n= 15, 18, 33, 16) | 3.2 bpm | Standard Deviation 7.97 |
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Post-Dose (n= 17, 15, 32, 16) | 2.7 bpm | Standard Deviation 10.1 |
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 2, Post-Dose (n= 16, 17, 30, 16) | 1.6 bpm | Standard Deviation 9.04 |
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 4, Post-Dose (n= 15, 15, 30, 16) | 2.5 bpm | Standard Deviation 10.08 |
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Pre-Dose (n= 15, 16, 28, 15) | 0.7 bpm | Standard Deviation 6.16 |
| UK-432,097 150 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Post-Dose (n= 14, 16, 28, 15) | 2.2 bpm | Standard Deviation 8.23 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 4, Post-Dose (n= 15, 15, 30, 16) | 1.3 bpm | Standard Deviation 10.15 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 2, Post-Dose (n= 16, 17, 30, 16) | -1.7 bpm | Standard Deviation 10.8 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 0, Post-Dose (n= 16, 18, 35, 17) | 2.5 bpm | Standard Deviation 6.72 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Post-Dose (n= 14, 16, 28, 15) | -0.2 bpm | Standard Deviation 7.44 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Pre-Dose (n= 15, 16, 28, 15) | -0.1 bpm | Standard Deviation 6.7 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Post-Dose (n= 17, 15, 32, 16) | 2.2 bpm | Standard Deviation 7.47 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Pre-Dose (n= 15, 18, 33, 16) | 4.7 bpm | Standard Deviation 10.97 |
| UK-432,097 450 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Baseline (n= 17, 18, 35, 17) | 75.2 bpm | Standard Deviation 12.37 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Pre-Dose (n= 15, 16, 28, 15) | 0.9 bpm | Standard Deviation 11.39 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Pre-Dose (n= 15, 18, 33, 16) | 0.8 bpm | Standard Deviation 9.95 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Post-Dose (n= 17, 15, 32, 16) | 1.1 bpm | Standard Deviation 8.91 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 2, Post-Dose (n= 16, 17, 30, 16) | 2.7 bpm | Standard Deviation 12.39 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 4, Post-Dose (n= 15, 15, 30, 16) | 3.8 bpm | Standard Deviation 16.52 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Post-Dose (n= 14, 16, 28, 15) | 3.5 bpm | Standard Deviation 12.85 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Baseline (n= 17, 18, 35, 17) | 73.7 bpm | Standard Deviation 12.83 |
| UK-432,097 1350 Mcg | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 0, Post-Dose (n= 16, 18, 35, 17) | 1.3 bpm | Standard Deviation 7.63 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Pre-Dose (n= 15, 18, 33, 16) | -0.3 bpm | Standard Deviation 10.1 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 1, Post-Dose (n= 17, 15, 32, 16) | 0.5 bpm | Standard Deviation 10.47 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 0, Post-Dose (n= 16, 18, 35, 17) | 0.3 bpm | Standard Deviation 7.86 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Baseline (n= 17, 18, 35, 17) | 74.2 bpm | Standard Deviation 13.07 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 2, Post-Dose (n= 16, 17, 30, 16) | 0.1 bpm | Standard Deviation 6.97 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Post-Dose (n= 14, 16, 28, 15) | 1.2 bpm | Standard Deviation 8.88 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 6, Pre-Dose (n= 15, 16, 28, 15) | -1.2 bpm | Standard Deviation 6.57 |
| Placebo | Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6 | Change at Week 4, Post-Dose (n= 15, 15, 30, 16) | 2.4 bpm | Standard Deviation 7.73 |
Other Pre-specified
Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.
Time frame: Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6
Population: Data for this pre-specified endpoint was not analyzed, as the study was terminated due to futility based on results of interim analysis.