Trial Outcomes & Findings for Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (NCT NCT00846586)
NCT ID: NCT00846586
Last Updated: 2011-08-18
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). Standardized FEV1 AUC was calculated by the trapezoidal rule. 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
1134 participants
Primary outcome timeframe
From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
Results posted on
2011-08-18
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
|
570
|
564
|
|
Overall Study
Received Study Drug
|
570
|
561
|
|
Overall Study
COMPLETED
|
531
|
529
|
|
Overall Study
NOT COMPLETED
|
39
|
35
|
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
|
20
|
10
|
|
Overall Study
Subject withdrew consent
|
8
|
10
|
|
Overall Study
Administrative problems
|
5
|
4
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Protocol deviation
|
2
|
6
|
|
Overall Study
Abnormal test procedure result(s)
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
1
|
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=570 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=561 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=1131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.0 years
STANDARD_DEVIATION 9.07 • n=99 Participants
|
63.4 years
STANDARD_DEVIATION 9.22 • n=107 Participants
|
63.7 years
STANDARD_DEVIATION 9.14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=99 Participants
|
183 Participants
n=107 Participants
|
354 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
399 Participants
n=99 Participants
|
378 Participants
n=107 Participants
|
777 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From 5 minutes to 8 hours post-dose at the end of treatment (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). Standardized FEV1 AUC was calculated by the trapezoidal rule. 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=505 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 Treatment (Week 12)
|
1.50 Liters
Standard Error 0.014
|
1.38 Liters
Standard Error 0.014
|
SECONDARY outcome
Timeframe: 24 hours post-dose at the end of treatment (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. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). 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=561 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=549 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 Treatment (Week 12 + 1 Day, Day 85)
|
1.38 Liters
Standard Error 0.014
|
1.30 Liters
Standard Error 0.014
|
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. Standardized FEV1 AUC was calculated by the trapezoidal rule. 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=544 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=523 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 0.009
|
1.32 Liters
Standard Error 0.009
|
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. Measurements were made at 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=553 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=541 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
|
1.36 Liters
Standard Error 0.011
|
1.27 Liters
Standard Error 0.012
|
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. Standardized FEV1 AUC was calculated by the trapezoidal rule. 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=552 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=527 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 0.008
|
1.31 Liters
Standard Error 0.008
|
SECONDARY outcome
Timeframe: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)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 treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. 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=516 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 Treatment (Week 12)
|
1.52 Liters
Standard Error 0.013
|
1.38 Liters
Standard Error 0.013
|
Adverse Events
Indacaterol 150 μg and Tiotropium 18 μg
Serious events: 21 serious events
Other events: 99 other events
Deaths: 0 deaths
Tiotropium 18 μg
Serious events: 17 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=570 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=561 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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.35%
2/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.36%
2/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.35%
2/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.36%
2/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.35%
2/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Myoglobinuria
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Residual urine
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
6/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
2.0%
11/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
1/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.00%
0/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
0.18%
1/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Indacaterol 150 μg and Tiotropium 18 μg
n=570 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=561 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
|
8.4%
48/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
9.1%
51/561 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
59/570 • Baseline to the end of the study (Week 12)
Safety set: All patients who received at least 1 dose of study drug.
|
3.7%
21/561 • Baseline to the end of the study (Week 12)
Safety set: 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