COPD
Conditions
Keywords
COPD, adults, β2-agonist, indacaterol
Brief summary
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients
Interventions
DRUGIndacaterol
Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
DRUGPlacebo
Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients eligible to participate in the study extension, by definition, will have met the inclusion and
Exclusion criteria
for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE). * In addition the following inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Weeks 12, 26, 36, 44 and 52 | The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate. |
| The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Up to 52 weeks | The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTC interval= \>450 ms for males and \>470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and \>60 ms. |
| Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Weeks 12, 26, 36, 44 and 52 | The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate. |
| The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Up to 52 weeks | The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: \<40 bpm or \<= to 50 bpm and a decrease from baseline \>= to 15 bpm. High Pulse Rate was defined as a pulse rate: \>130 bpm or \>= to 120 bpm and an increase from baseline \>= to 15 bpm. |
| The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Up to 52 weeks | The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: \<75 mmHg or \<= to 90 mmHg and a decrease from baseline \>= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: \>200 mmHg or \>= to 180 mmHg and an increase from baseline \>= to 20 mmHg. |
| The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Up to 52 weeks | The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \<40 mmHg or \<= to 50 mmHg and a decrease from baseline \>= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \>115 mmHg or \>= to 105 mmHg and an increase from baseline \>= to 15 mmHg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Weeks 36, 44 and 52 | The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates. SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant. |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment | Week 52 | Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates. |
Countries
Argentina, Canada, Germany, India, Italy, Spain, Sweden, Turkey (Türkiye), United States
Participant flow
Recruitment details
This is an extension study to core study stage 2: CQAB149B2335S (NCT00463567).
Participants by arm
| Arm | Count |
|---|---|
| Indacaterol 150 µg Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. | 144 |
| Indacaterol 300 µg Indacaterol 300 µg once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. | 146 |
| Placebo Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. | 124 |
| Total | 414 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems | 1 | 1 | 2 |
| Overall Study | Adverse Event | 4 | 1 | 6 |
| Overall Study | Death | 0 | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 2 | 2 |
| Overall Study | Participant no longer needs study drug | 0 | 0 | 1 |
| Overall Study | Protocol Deviation | 1 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 3 | 6 |
Baseline characteristics
| Characteristic | Indacaterol 150 µg | Indacaterol 300 µg | Placebo | Total |
|---|---|---|---|---|
| Age Continuous | 62.5 years STANDARD_DEVIATION 9.52 | 62.5 years STANDARD_DEVIATION 9 | 62.8 years STANDARD_DEVIATION 9.18 | 62.6 years STANDARD_DEVIATION 9.21 |
| Sex: Female, Male Female | 57 Participants | 60 Participants | 43 Participants | 160 Participants |
| Sex: Female, Male Male | 87 Participants | 86 Participants | 81 Participants | 254 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 86 / 144 | 91 / 146 | 67 / 124 |
| serious Total, serious adverse events | 15 / 144 | 18 / 146 | 13 / 124 |
Outcome results
Primary
Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52
The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.
Time frame: Weeks 12, 26, 36, 44 and 52
Population: Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol 150 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 44 (n=131, 133, 105) | 5.70 mmol/L | Standard Error 0.189 |
| Indacaterol 150 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 36 (n=134, 136, 111) | 5.81 mmol/L | Standard Error 0.156 |
| Indacaterol 150 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 12 (n=142, 140, 118) | 5.50 mmol/L | Standard Error 0.139 |
| Indacaterol 150 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 26 (n=137, 143, 118) | 5.93 mmol/L | Standard Error 0.169 |
| Indacaterol 150 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 52 (n=123, 131, 99) | 5.93 mmol/L | Standard Error 0.201 |
| Indacaterol 300 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 36 (n=134, 136, 111) | 5.75 mmol/L | Standard Error 0.151 |
| Indacaterol 300 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 12 (n=142, 140, 118) | 5.59 mmol/L | Standard Error 0.134 |
| Indacaterol 300 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 26 (n=137, 143, 118) | 5.77 mmol/L | Standard Error 0.16 |
| Indacaterol 300 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 44 (n=131, 133, 105) | 5.88 mmol/L | Standard Error 0.176 |
| Indacaterol 300 µg | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 52 (n=123, 131, 99) | 5.70 mmol/L | Standard Error 0.189 |
| Placebo | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 52 (n=123, 131, 99) | 5.55 mmol/L | Standard Error 0.221 |
| Placebo | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 44 (n=131, 133, 105) | 5.60 mmol/L | Standard Error 0.205 |
| Placebo | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 12 (n=142, 140, 118) | 5.18 mmol/L | Standard Error 0.15 |
| Placebo | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 36 (n=134, 136, 111) | 5.66 mmol/L | Standard Error 0.171 |
| Placebo | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 | Week 26 (n=137, 143, 118) | 5.49 mmol/L | Standard Error 0.18 |
Primary
Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52
The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.
Time frame: Weeks 12, 26, 36, 44 and 52
Population: Extension safety population consisting of all participants who received at least one dose of study drug in the extension study. n in the categories is the number of participants with data at the given time point for each treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol 150 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 44 (n=129, 130, 103) | 4.52 mmol/L | Standard Error 0.05 |
| Indacaterol 150 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 36 (n=132, 133, 109) | 4.46 mmol/L | Standard Error 0.051 |
| Indacaterol 150 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 12 (n=140, 138, 115) | 4.45 mmol/L | Standard Error 0.045 |
| Indacaterol 150 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 26 (n=135, 141, 114) | 4.53 mmol/L | Standard Error 0.049 |
| Indacaterol 150 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 52 (n=121, 129, 97) | 4.42 mmol/L | Standard Error 0.053 |
| Indacaterol 300 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 36 (n=132, 133, 109) | 4.49 mmol/L | Standard Error 0.05 |
| Indacaterol 300 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 12 (n=140, 138, 115) | 4.50 mmol/L | Standard Error 0.044 |
| Indacaterol 300 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 26 (n=135, 141, 114) | 4.53 mmol/L | Standard Error 0.047 |
| Indacaterol 300 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 44 (n=129, 130, 103) | 4.51 mmol/L | Standard Error 0.048 |
| Indacaterol 300 µg | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 52 (n=121, 129, 97) | 4.54 mmol/L | Standard Error 0.05 |
| Placebo | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 52 (n=121, 129, 97) | 4.49 mmol/L | Standard Error 0.059 |
| Placebo | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 44 (n=129, 130, 103) | 4.55 mmol/L | Standard Error 0.055 |
| Placebo | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 12 (n=140, 138, 115) | 4.45 mmol/L | Standard Error 0.05 |
| Placebo | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 36 (n=132, 133, 109) | 4.55 mmol/L | Standard Error 0.057 |
| Placebo | Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 | Week 26 (n=135, 141, 114) | 4.55 mmol/L | Standard Error 0.053 |
Primary
The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \<40 mmHg or \<= to 50 mmHg and a decrease from baseline \>= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: \>115 mmHg or \>= to 105 mmHg and an increase from baseline \>= to 15 mmHg.
Time frame: Up to 52 weeks
Population: Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Diastolic Blood Pressure | 6 participants |
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Diastolic Blood Pressure | 1 participants |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Diastolic Blood Pressure | 3 participants |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Diastolic Blood Pressure | 0 participants |
| Placebo | The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Diastolic Blood Pressure | 2 participants |
| Placebo | The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Diastolic Blood Pressure | 2 participants |
Primary
The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate: \<40 bpm or \<= to 50 bpm and a decrease from baseline \>= to 15 bpm. High Pulse Rate was defined as a pulse rate: \>130 bpm or \>= to 120 bpm and an increase from baseline \>= to 15 bpm.
Time frame: Up to 52 weeks
Population: Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Pulse Rate | 3 Participants |
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Pulse Rate | 0 Participants |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Pulse Rate | 3 Participants |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Pulse Rate | 1 Participants |
| Placebo | The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Pulse Rate | 2 Participants |
| Placebo | The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Pulse Rate | 0 Participants |
Primary
The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTC interval= \>450 ms for males and \>470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and \>60 ms.
Time frame: Up to 52 weeks
Population: Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | QTc increase from BL: 30-60 ms | 28 participant |
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Notable QTc | 10 participant |
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | QTc increase from BL: >60 ms | 1 participant |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | QTc increase from BL: 30-60 ms | 30 participant |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Notable QTc | 9 participant |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | QTc increase from BL: >60 ms | 1 participant |
| Placebo | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Notable QTc | 11 participant |
| Placebo | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | QTc increase from BL: >60 ms | 1 participant |
| Placebo | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | QTc increase from BL: 30-60 ms | 30 participant |
Primary
The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo
The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: \<75 mmHg or \<= to 90 mmHg and a decrease from baseline \>= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: \>200 mmHg or \>= to 180 mmHg and an increase from baseline \>= to 20 mmHg.
Time frame: Up to 52 weeks
Population: Extension safety population consisting of all participants who received at least one dose of study drug in the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Systolic Blood Pressure | 2 participants |
| Indacaterol 150 µg | The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Systolic Blood Pressure | 1 participants |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Systolic Blood Pressure | 2 participants |
| Indacaterol 300 µg | The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Systolic Blood Pressure | 2 participants |
| Placebo | The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | Low Systolic Blood Pressure | 2 participants |
| Placebo | The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo | High Systolic Blood Pressure | 2 participants |
Secondary
Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52
The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates. SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant.
Time frame: Weeks 36, 44 and 52
Population: Extension Intent-to-treat population consisting of all participants who received at least one dose of study drug. n in each of the categories is the number of participants with data at the given time point. Missing data were imputed using LOCF but not by more than 14 weeks and not by carrying forward scores within 4 weeks of treatment start.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol 150 µg | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 44 (n= 128, 133, 109) | 35.98 Score on a Scale | Standard Error 1.883 |
| Indacaterol 150 µg | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 36 (n=138, 137, 113) | 36.62 Score on a Scale | Standard Error 1.767 |
| Indacaterol 150 µg | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 52 (n=126, 132, 104) | 35.97 Score on a Scale | Standard Error 1.826 |
| Indacaterol 300 µg | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 44 (n= 128, 133, 109) | 36.18 Score on a Scale | Standard Error 1.739 |
| Indacaterol 300 µg | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 36 (n=138, 137, 113) | 36.37 Score on a Scale | Standard Error 1.695 |
| Indacaterol 300 µg | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 52 (n=126, 132, 104) | 37.49 Score on a Scale | Standard Error 1.721 |
| Placebo | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 36 (n=138, 137, 113) | 39.56 Score on a Scale | Standard Error 1.913 |
| Placebo | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 52 (n=126, 132, 104) | 39.19 Score on a Scale | Standard Error 2.004 |
| Placebo | Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 | Week 44 (n= 128, 133, 109) | 41.67 Score on a Scale | Standard Error 2.001 |
Secondary
Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.
Time frame: Week 52
Population: Participants from the Extension Intent-to-treat population (consisting of all participants who received at least one dose of study drug) for whom data was available for this Outcome Measure. Missing data was imputed Last Observation Carried Forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol 150 µg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment | 1.44 Liters | Standard Error 0.034 |
| Indacaterol 300 µg | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment | 1.45 Liters | Standard Error 0.032 |
| Placebo | Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment | 1.27 Liters | Standard Error 0.037 |