Trial Outcomes & Findings for Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (NCT NCT00877383)
NCT ID: NCT00877383
Last Updated: 2011-08-25
Results Overview
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1142 participants
Primary outcome timeframe
From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)
Results posted on
2011-08-25
Participant Flow
Participant milestones
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
572
|
570
|
|
Overall Study
COMPLETED
|
543
|
533
|
|
Overall Study
NOT COMPLETED
|
29
|
37
|
Reasons for withdrawal
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
14
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Subject withdrew consent
|
3
|
12
|
|
Overall Study
Subject no longer requires study drug
|
2
|
0
|
|
Overall Study
Administrative problems
|
2
|
0
|
|
Overall Study
Protocol deviation
|
2
|
6
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
0
|
|
Overall Study
Death
|
1
|
2
|
Baseline Characteristics
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=572 Participants
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=570 Participants
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Total
n=1142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.1 years
STANDARD_DEVIATION 8.83 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 8.98 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
360 Participants
n=5 Participants
|
387 Participants
n=7 Participants
|
747 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)Population: Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=530 Participants
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=504 Participants
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84)
|
1.46 Liters
Standard Error 0.011
|
1.34 Liters
Standard Error 0.011
|
SECONDARY outcome
Timeframe: End of the study (Week 12 + 1 day, Day 85)Population: Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=565 Participants
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=564 Participants
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
|
1.34 Liters
Standard Error 0.010
|
1.27 Liters
Standard Error 0.010
|
SECONDARY outcome
Timeframe: From 5 minutes to 8 hours post-dose on Day 1Population: Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=551 Participants
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=540 Participants
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1
|
1.40 Liters
Standard Error 0.007
|
1.33 Liters
Standard Error 0.007
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 2Population: Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=563 Participants
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=558 Participants
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
|
1.34 Liters
Standard Error 0.008
|
1.26 Liters
Standard Error 0.008
|
SECONDARY outcome
Timeframe: From 5 minutes to 4 hours post-dose on Day 1Population: Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=556 Participants
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=550 Participants
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1
|
1.38 Liters
Standard Error 0.007
|
1.32 Liters
Standard Error 0.007
|
SECONDARY outcome
Timeframe: From 5 minutes to 4 hours post-dose at the end of the study (Week 12, Day 84)Population: Full analysis set (FAS): All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=532 Participants
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=511 Participants
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of the Study (Week 12, Day 84)
|
1.48 Liters
Standard Error 0.011
|
1.34 Liters
Standard Error 0.011
|
Adverse Events
Indacaterol 150 μg and Tiotropium 18 μg
Serious events: 19 serious events
Other events: 83 other events
Deaths: 0 deaths
Tiotropium 18 μg
Serious events: 18 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=572 participants at risk
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=570 participants at risk
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.35%
2/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.70%
4/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
9/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
1.6%
9/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.35%
2/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.17%
1/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=572 participants at risk
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Tiotropium 18 μg
n=570 participants at risk
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.6%
38/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
9.1%
52/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
52/572 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
4.4%
25/570 • Baseline to the end of the study (Week 12)
Safety population: All patients who received at least 1 dose of study drug.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER