Asthma
Conditions
Brief summary
The purpose of this study is to compare once and twice daily GW685698 in asthma
Interventions
DRUGGW685698X
Inhaled Corticosteroid
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Clinical diagnosis of Asthma * Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol * FEV1 between 40-85% predicted * Currently on short acting beta2 agonist therapy Key
Exclusion criteria
* History of life threatening asthma * Respiratory Infection or oropharyngeal candidiasis * Asthma exacerbation * Uncontrolled disease or clinical abnormality * Allergies * Taking another Investigational medications or other prohibited medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | Day 28 of the relevant treatment period (up to Study Day 112) | Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | Day 28 of the relevant treatment period (up to Study Day 112) | A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period. |
| Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) | Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. |
| Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | From the first dose of the study medication up to Week 16/Early Withdrawal | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold \>=3%) and SAEs. |
| Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) | Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. |
| Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods | From the first dose of the study medication up to Week 16/Early Withdrawal | Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which \>=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol. |
| Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. |
Countries
United States
Participant flow
Pre-assignment details
Eligible participants (par.) at screening entered a 14-day Run-in Period. Par. were then randomized to 1 of 12 sequences: 6 had placebo and two doses of fluticasone furoate (FF), and 6 had placebo and two doses of fluticasone proprionate (FP) (allocation ratio of 7:2 \[FF:FP\]). 320 par. were screened and 190 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| FF 200 µg, FF 100 µg, and Placebo Via DPI Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. | 147 |
| FP 200 µg, FP 100 µg, and Placebo Via DISKUS Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. | 43 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (28 Days) | Lack of Efficacy | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1 (28 Days) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Treatment Period 1 (28 Days) | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 2 (28 Days) | Lack of Efficacy | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 2 (28 Days) | Lost to Follow-up | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 3 (28 Days) | Lack of Efficacy | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Treatment Period 3 (28 Days) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 3 (28 Days) | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Washout Period 1 (14 Days) | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Washout Period 2 (14 Days) | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | FF 200 µg, FF 100 µg, and Placebo Via DPI | FP 200 µg, FP 100 µg, and Placebo Via DISKUS | Total |
|---|---|---|---|
| Age, Continuous | 31.4 Years STANDARD_DEVIATION 15.3 | 35.2 Years STANDARD_DEVIATION 16.03 | 32.3 Years STANDARD_DEVIATION 15.51 |
| Gender Female | 87 Participants | 21 Participants | 108 Participants |
| Gender Male | 60 Participants | 22 Participants | 82 Participants |
| Race/Ethnicity, Customized African American/African HER & AI or AN & White | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized African American/African Heritage (HER) | 50 participants | 20 participants | 70 participants |
| Race/Ethnicity, Customized African American/African Heritage & White | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized American Indian (AI) or Alaska Native (AN) | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Japanese/East Asian HER/South East Asian HER | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 90 participants | 22 participants | 112 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 187 | 7 / 140 | 7 / 142 | 0 / 42 | 0 / 43 |
| serious Total, serious adverse events | 0 / 187 | 0 / 140 | 0 / 142 | 0 / 42 | 0 / 43 |
Outcome results
Primary
Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.
Time frame: Day 28 of the relevant treatment period (up to Study Day 112)
Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | 2.605 Liters | Standard Error 0.0434 |
| FF 200 µg OD | Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | 2.714 Liters | Standard Error 0.0444 |
| FF 100 µg BID | Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | 2.703 Liters | Standard Error 0.0443 |
| FP 200 µg OD | Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | 2.693 Liters | Standard Error 0.0535 |
| FP 100 µg BID | Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | 2.737 Liters | Standard Error 0.0533 |
p-value: <0.00195% CI: [0.064, 0.153]ANCOVA
p-value: <0.00195% CI: [0.054, 0.142]ANCOVA
p-value: 0.0295% CI: [0.014, 0.161]ANCOVA
p-value: 0.64195% CI: [-0.035, 0.056]ANCOVA
p-value: <0.00195% CI: [0.059, 0.205]ANCOVA
Secondary
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period.
Time frame: Day 28 of the relevant treatment period (up to Study Day 112)
Population: Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | 53.94 Nanomoles per 24 hours | Geometric Coefficient of Variation 66.423 |
| FF 200 µg OD | 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | 40.25 Nanomoles per 24 hours | Geometric Coefficient of Variation 92.316 |
| FF 100 µg BID | 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | 45.13 Nanomoles per 24 hours | Geometric Coefficient of Variation 87.181 |
| FP 200 µg OD | 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | 56.16 Nanomoles per 24 hours | Geometric Coefficient of Variation 94.259 |
| FP 100 µg BID | 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | 47.56 Nanomoles per 24 hours | Geometric Coefficient of Variation 84.896 |
Secondary
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 0, n=187, 140, 142, 42, 43 | 77.0 beats per minute | Standard Deviation 9.53 |
| Placebo | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 28, n=178, 139, 140, 42, 42 | 76.6 beats per minute | Standard Deviation 8.79 |
| FF 200 µg OD | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 28, n=178, 139, 140, 42, 42 | 76.9 beats per minute | Standard Deviation 9.32 |
| FF 200 µg OD | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 0, n=187, 140, 142, 42, 43 | 76.4 beats per minute | Standard Deviation 9.27 |
| FF 100 µg BID | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 0, n=187, 140, 142, 42, 43 | 77.6 beats per minute | Standard Deviation 8.71 |
| FF 100 µg BID | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 28, n=178, 139, 140, 42, 42 | 77.7 beats per minute | Standard Deviation 9.47 |
| FP 200 µg OD | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 0, n=187, 140, 142, 42, 43 | 74.5 beats per minute | Standard Deviation 9.22 |
| FP 200 µg OD | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 28, n=178, 139, 140, 42, 42 | 74.7 beats per minute | Standard Deviation 7.96 |
| FP 100 µg BID | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 28, n=178, 139, 140, 42, 42 | 74.6 beats per minute | Standard Deviation 8.49 |
| FP 100 µg BID | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Day 0, n=187, 140, 142, 42, 43 | 75.8 beats per minute | Standard Deviation 8.12 |
Secondary
Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods
Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which \>=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol.
Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods | 5 participants |
| FF 200 µg OD | Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods | 1 participants |
Secondary
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold \>=3%) and SAEs.
Time frame: From the first dose of the study medication up to Week 16/Early Withdrawal
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any AE | 26 participants |
| Placebo | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any SAE | 0 participants |
| FF 200 µg OD | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any SAE | 0 participants |
| FF 200 µg OD | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any AE | 22 participants |
| FF 100 µg BID | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any SAE | 0 participants |
| FF 100 µg BID | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any AE | 26 participants |
| FP 200 µg OD | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any AE | 2 participants |
| FP 200 µg OD | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any SAE | 0 participants |
| FP 100 µg BID | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any AE | 3 participants |
| FP 100 µg BID | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | Any SAE | 0 participants |
Secondary
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: Yes, n=187, 140, 142, 42, 43 | 0 participants |
| Placebo | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: No, n=187, 140, 142, 42, 43 | 187 participants |
| Placebo | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: Yes, n=178, 139, 140, 42, 42 | 0 participants |
| Placebo | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: No, n=178, 139, 140, 42, 42 | 178 participants |
| FF 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: Yes, n=187, 140, 142, 42, 43 | 0 participants |
| FF 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: No, n=178, 139, 140, 42, 42 | 139 participants |
| FF 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: No, n=187, 140, 142, 42, 43 | 140 participants |
| FF 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: Yes, n=178, 139, 140, 42, 42 | 0 participants |
| FF 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: No, n=178, 139, 140, 42, 42 | 140 participants |
| FF 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: No, n=187, 140, 142, 42, 43 | 142 participants |
| FF 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: Yes, n=178, 139, 140, 42, 42 | 0 participants |
| FF 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: Yes, n=187, 140, 142, 42, 43 | 0 participants |
| FP 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: Yes, n=187, 140, 142, 42, 43 | 0 participants |
| FP 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: No, n=187, 140, 142, 42, 43 | 42 participants |
| FP 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: No, n=178, 139, 140, 42, 42 | 42 participants |
| FP 200 µg OD | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: Yes, n=178, 139, 140, 42, 42 | 0 participants |
| FP 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: No, n=178, 139, 140, 42, 42 | 42 participants |
| FP 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 28: Yes, n=178, 139, 140, 42, 42 | 0 participants |
| FP 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: No, n=187, 140, 142, 42, 43 | 43 participants |
| FP 100 µg BID | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Day 0: Yes, n=187, 140, 142, 42, 43 | 0 participants |
Secondary
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period.
Time frame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 0, n=187, 140, 142, 42, 43 | 120.1 millimeters of mercury (mmHg) | Standard Deviation 12.08 |
| Placebo | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 28, n=178, 139, 140, 42, 42 | 119.6 millimeters of mercury (mmHg) | Standard Deviation 12.76 |
| Placebo | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 0, n=187, 140, 142, 42, 43 | 75.8 millimeters of mercury (mmHg) | Standard Deviation 8.26 |
| Placebo | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 28, n=178, 139, 140, 42, 42 | 75.8 millimeters of mercury (mmHg) | Standard Deviation 8.45 |
| FF 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 0, n=187, 140, 142, 42, 43 | 118.3 millimeters of mercury (mmHg) | Standard Deviation 11.96 |
| FF 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 28, n=178, 139, 140, 42, 42 | 74.9 millimeters of mercury (mmHg) | Standard Deviation 8.12 |
| FF 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 28, n=178, 139, 140, 42, 42 | 120.5 millimeters of mercury (mmHg) | Standard Deviation 13.31 |
| FF 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 0, n=187, 140, 142, 42, 43 | 74.6 millimeters of mercury (mmHg) | Standard Deviation 7.69 |
| FF 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 28, n=178, 139, 140, 42, 42 | 76.4 millimeters of mercury (mmHg) | Standard Deviation 7.97 |
| FF 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 28, n=178, 139, 140, 42, 42 | 120.6 millimeters of mercury (mmHg) | Standard Deviation 12.71 |
| FF 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 0, n=187, 140, 142, 42, 43 | 76.0 millimeters of mercury (mmHg) | Standard Deviation 8.03 |
| FF 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 0, n=187, 140, 142, 42, 43 | 119.5 millimeters of mercury (mmHg) | Standard Deviation 12.28 |
| FP 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 0, n=187, 140, 142, 42, 43 | 122.1 millimeters of mercury (mmHg) | Standard Deviation 13.55 |
| FP 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 28, n=178, 139, 140, 42, 42 | 120.4 millimeters of mercury (mmHg) | Standard Deviation 11.92 |
| FP 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 28, n=178, 139, 140, 42, 42 | 76.0 millimeters of mercury (mmHg) | Standard Deviation 7.81 |
| FP 200 µg OD | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 0, n=187, 140, 142, 42, 43 | 77.5 millimeters of mercury (mmHg) | Standard Deviation 9.98 |
| FP 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 28, n=178, 139, 140, 42, 42 | 75.7 millimeters of mercury (mmHg) | Standard Deviation 8.9 |
| FP 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | DBP: Day 0, n=187, 140, 142, 42, 43 | 76.6 millimeters of mercury (mmHg) | Standard Deviation 8.73 |
| FP 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 28, n=178, 139, 140, 42, 42 | 120.1 millimeters of mercury (mmHg) | Standard Deviation 10.58 |
| FP 100 µg BID | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | SBP: Day 0, n=187, 140, 142, 42, 43 | 121.3 millimeters of mercury (mmHg) | Standard Deviation 12.1 |