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Trial record 39 of 185 for:    GLYCOPYRROLATE

Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00558285
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : November 22, 2012
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: indacaterol/glycopyrrolate
Drug: indacaterol
Drug: glycopyrrolate
Drug: placebo
Enrollment 257
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indacaterol/Glycopyrrolate 600 μg/100 μg Indacaterol/Glycopyrrolate 300 μg/100 μg Indacaterol/Glycopyrrolate 150 μg/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description

Two capsules indacaterol/glycopyrrolate 300 μg/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300 μg/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150 μg/50 μg and one capsule 50μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Period Title: Overall Study
Started 50 51 51 52 53
Safety: Received Study Drug 49 51 51 51 53
Completed 44 48 46 48 49
Not Completed 6 3 5 4 4
Reason Not Completed
Adverse Event             1             1             4             1             2
Abnormal test procedure result(s)             1             0             0             0             0
Subject withdrew consent             2             0             1             1             1
Lost to Follow-up             1             1             0             0             0
Administrative problems             0             0             0             1             1
Protocol deviation             1             1             0             1             0
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo Total
Hide Arm/Group Description

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Total of all reporting groups
Overall Number of Baseline Participants 49 51 51 51 53 255
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 51 participants 51 participants 51 participants 53 participants 255 participants
65.7  (9.34) 63.7  (8.94) 60.9  (8.58) 64.5  (9.75) 64.3  (8.95) 63.8  (9.19)
[1]
Measure Description: Overall Number of Baseline Participants is based on the Safety Population
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 51 participants 51 participants 51 participants 53 participants 255 participants
Female
11
  22.4%
10
  19.6%
15
  29.4%
10
  19.6%
14
  26.4%
60
  23.5%
Male
38
  77.6%
41
  80.4%
36
  70.6%
41
  80.4%
39
  73.6%
195
  76.5%
1.Primary Outcome
Title Change From Baseline in Mean 24 Hour Heart Rate at Day 14
Hide Description Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description:

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Overall Number of Participants Analyzed 39 45 40 42 45
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
-0.113  (0.9967) 0.787  (0.8975) -0.230  (0.9567) 0.240  (0.9373) 0.170  (0.8760)
2.Secondary Outcome
Title Change From Baseline in Mean 24 Hour Heart Rate at Day 1
Hide Description Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.
Time Frame Baseline, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis.
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description:

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Overall Number of Participants Analyzed 45 46 47 48 47
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
-2.877  (0.8790) -2.770  (0.8244) -0.547  (0.8208) -1.849  (0.8211) -0.329  (0.8181)
3.Secondary Outcome
Title Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14
Hide Description Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.
Time Frame Day 1, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population includes all randomized patients. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description:

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Overall Number of Participants Analyzed 50 51 51 52 53
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 1 1.59  (0.024) 1.51  (0.023) 1.50  (0.022) 1.44  (0.023) 1.27  (0.022)
Day 14 1.61  (0.027) 1.52  (0.025) 1.50  (0.026) 1.46  (0.025) 1.31  (0.024)
4.Secondary Outcome
Title Trough Forced Vital Capacity (FVC) at Day 1 and Day 14
Hide Description Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.
Time Frame Day 1 and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat Population (all randomized patients) with data available at the given time-point. Any spirometric data collected less than six hours after rescue medication use was regarded as missing.
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description:

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Overall Number of Participants Analyzed 48 48 51 49 52
Least Squares Mean (Standard Error)
Unit of Measure: Liters
Day 1 3.151  (0.0437) 3.029  (0.0421) 3.000  (0.0403) 2.924  (0.0419) 2.634  (0.0402)
Day 14 (n=42, 45, 44, 48, 47) 3.134  (0.0469) 3.042  (0.0446) 2.952  (0.0455) 2.901  (0.0442) 2.726  (0.0424)
5.Secondary Outcome
Title Change From Baseline in QTc (Fridericia's Formula) at Day 1
Hide Description The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.
Time Frame Baseline, Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all patients who received at least one dose of study drug.
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description:

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Overall Number of Participants Analyzed 49 51 51 51 53
Least Squares Mean (Standard Error)
Unit of Measure: milliseconds
30 minutes 1.6  (1.58) 1.2  (1.48) 1.4  (1.50) 3.1  (1.47) -1.6  (1.44)
4 hours 2.8  (1.67) 0.5  (1.56) 2.4  (1.58) 1.1  (1.60) -2.3  (1.52)
23 hours 45 minutes 2.7  (1.77) -1.7  (1.66) -0.1  (1.67) -2.1  (1.71) -2.3  (1.62)
6.Secondary Outcome
Title Change From Baseline in QTc (Fridericia's Formula) at Day 7
Hide Description The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.
Time Frame Baseline, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all patients who received at least one dose of study drug.
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description:

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Overall Number of Participants Analyzed 49 51 51 51 53
Least Squares Mean (Standard Error)
Unit of Measure: milliseconds
30 minutes 4.1  (1.91) -0.9  (1.74) 0.5  (1.78) -1.3  (1.79) -2.2  (1.70)
2 hours 2.6  (2.17) -1.2  (1.98) 1.6  (2.02) -1.6  (2.00) -2.8  (1.94)
7.Secondary Outcome
Title Change From Baseline in QTc (Fridericia's Formula) at Day 14
Hide Description The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia’s formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.
Time Frame Baseline, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population includes all patients who received at least one dose of study drug.
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description:

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Overall Number of Participants Analyzed 49 51 51 51 53
Least Squares Mean (Standard Error)
Unit of Measure: milliseconds
30 minutes 2.4  (1.79) -0.6  (1.64) 1.6  (1.70) -1.2  (1.69) 0.2  (1.62)
4 hours 2.8  (1.90) -0.1  (1.76) 3.1  (1.85) -2.6  (1.81) -0.1  (1.73)
23 hours 45 minutes 0.5  (1.94) -2.9  (1.81) 0.4  (1.95) -3.6  (1.88) -1.6  (1.77)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Hide Arm/Group Description

Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.

The use of salbutamol /albuterol as rescue medication was permitted throughout the study.

All-Cause Mortality
Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/49 (4.08%)   0/51 (0.00%)   2/51 (3.92%)   0/51 (0.00%)   1/53 (1.89%) 
Blood and lymphatic system disorders           
Anaemia  1  0/49 (0.00%)  0/51 (0.00%)  1/51 (1.96%)  0/51 (0.00%)  0/53 (0.00%) 
Cardiac disorders           
Atrial fibrillation  1  1/49 (2.04%)  0/51 (0.00%)  0/51 (0.00%)  0/51 (0.00%)  0/53 (0.00%) 
Ventricular tachycardia  1  0/49 (0.00%)  0/51 (0.00%)  1/51 (1.96%)  0/51 (0.00%)  0/53 (0.00%) 
Investigations           
Blood potassium increased  1  1/49 (2.04%)  0/51 (0.00%)  0/51 (0.00%)  0/51 (0.00%)  0/53 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/49 (0.00%)  0/51 (0.00%)  0/51 (0.00%)  0/51 (0.00%)  1/53 (1.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Indacaterol/Glycopyrrolate 600/100 μg Indacaterol/Glycopyrrolate 300/100 μg Indacaterol/Glycopyrrolate 150/100 μg Indacaterol 300 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/49 (10.20%)   6/51 (11.76%)   10/51 (19.61%)   7/51 (13.73%)   4/53 (7.55%) 
Gastrointestinal disorders           
Dry mouth  1  3/49 (6.12%)  1/51 (1.96%)  3/51 (5.88%)  0/51 (0.00%)  0/53 (0.00%) 
Nervous system disorders           
Headache  1  2/49 (4.08%)  1/51 (1.96%)  2/51 (3.92%)  3/51 (5.88%)  1/53 (1.89%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/49 (0.00%)  2/51 (3.92%)  5/51 (9.80%)  1/51 (1.96%)  1/53 (1.89%) 
Cough  1  3/49 (6.12%)  2/51 (3.92%)  3/51 (5.88%)  2/51 (3.92%)  1/53 (1.89%) 
Vascular disorders           
Hypertension  1  0/49 (0.00%)  3/51 (5.88%)  1/51 (1.96%)  1/51 (1.96%)  1/53 (1.89%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 (i.e., data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00558285     History of Changes
Other Study ID Numbers: CQVA149A2203
First Submitted: November 12, 2007
First Posted: November 14, 2007
Results First Submitted: October 23, 2012
Results First Posted: November 22, 2012
Last Update Posted: November 30, 2012