Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 45 of 185 for:    GLYCOPYRROLATE

Efficacy and Safety of QVA149 in Patients With 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: NCT00570778
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : February 28, 2013
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: indacaterol/glycopyrrolate
Drug: indacaterol
Drug: placebo
Enrollment 154
Recruitment Details  
Pre-assignment Details This was 4 arm crossover study. There was a 7 day washout period between each treatment period. 154 patients were randomized, 153 participants received study drug. 5 patients were excluded from the Modified Intent-to-treat population (MITT). 4 patients for protocol violations and 1 patient was randomized but did not receive study drug.
Arm/Group Title A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg
Hide Arm/Group Description

Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.

Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.

Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.

Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.

Period Title: Overall Study
Started 41 38 37 38
Safety Population: Received Study Drug 41 [1] 38 36 38
Modified Intent-to-treat Population 40 37 35 37
Completed 37 34 30 34
Not Completed 4 4 7 4
Reason Not Completed
Protocol deviation             2             1             2             2
Adverse Event             0             1             4             1
Subject withdrew consent             0             1             0             1
Abnormal test procedure             1             0             0             0
Unsatisfactory therapeutic effect             1             0             0             0
Lost to Follow-up             0             0             1             0
Subject no longer requires study drug             0             1             0             0
[1]
Safety Population included all participants who received at least 1 dose of any study drug.
Arm/Group Title Overall Population
Hide Arm/Group Description Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.
Overall Number of Baseline Participants 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants
61.7  (8.5)
[1]
Measure Description: Baseline characteristics are based on the Safety Population that consists of all participants who received study drug.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants
Female
59
  38.6%
Male
94
  61.4%
1.Primary Outcome
Title Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Hide Description Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Time Frame Baseline, Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.
Arm/Group Title Indacaterol/Glycopyrrolate 300/50 μg Indacaterol 300 μg Indacaterol 600 μg Placebo
Hide Arm/Group Description:
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Overall Number of Participants Analyzed 140 138 140 136
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1.512  (0.0143) 1.389  (0.0144) 1.395  (0.0143) 1.286  (0.0145)
2.Secondary Outcome
Title Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Hide Description Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Modified Intent-to-treat population (includes all participants who received study drug) with data available for analysis.
Arm/Group Title Indacaterol/Glycopyrrolate 300/50 μg Indacaterol 300 μg Indacaterol 600 μg Placebo
Hide Arm/Group Description:
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Overall Number of Participants Analyzed 142 140 142 140
Least Squares Mean (Standard Error)
Unit of Measure: Liters
1.610  (0.0180) 1.473  (0.0181) 1.457  (0.0180) 1.317  (0.0185)
3.Secondary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Hide Description Additional information about adverse events can be found in the Adverse Event Section.
Time Frame 47 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population includes all participants who received at least 1 dose of study drug.
Arm/Group Title Indacaterol/Glycopyrrolate 300/50 μg Indacaterol 300 μg Indacaterol 600 μg Placebo
Hide Arm/Group Description:
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Overall Number of Participants Analyzed 142 141 141 143
Measure Type: Number
Unit of Measure: Participants
Serious Adverse Events 2 0 0 0
Adverse Events 39 31 37 31
Discontinuations Due to Adverse Events 3 0 2 0
Time Frame [Not Specified]
Adverse Event Reporting Description The number of patients in the safety population for the QAB 600 μg treatment is (N=141) compared to the safety population (N=142). One patient was mistakenly dosed with QAB149 600 μg in 2 out of 4 periods. For AEs, this patient was counted once, not twice, therefore the difference in one patient.
 
Arm/Group Title Indacaterol/Glycopyrrolate 300/50 μg Indacaterol 300 μg Indacaterol 600 μg Placebo
Hide Arm/Group Description One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
All-Cause Mortality
Indacaterol/Glycopyrrolate 300/50 μg Indacaterol 300 μg Indacaterol 600 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol/Glycopyrrolate 300/50 μg Indacaterol 300 μg Indacaterol 600 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/142 (1.41%)   0/141 (0.00%)   0/141 (0.00%)   0/143 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  1/142 (0.70%)  0/141 (0.00%)  0/141 (0.00%)  0/143 (0.00%) 
Humerus fracture  1  1/142 (0.70%)  0/141 (0.00%)  0/141 (0.00%)  0/143 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  1/142 (0.70%)  0/141 (0.00%)  0/141 (0.00%)  0/143 (0.00%) 
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 2%
Indacaterol/Glycopyrrolate 300/50 μg Indacaterol 300 μg Indacaterol 600 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/142 (8.45%)   14/141 (9.93%)   15/141 (10.64%)   15/143 (10.49%) 
Gastrointestinal disorders         
Diarrhoea  1  0/142 (0.00%)  3/141 (2.13%)  2/141 (1.42%)  2/143 (1.40%) 
Infections and infestations         
Nasopharyngitis  1  1/142 (0.70%)  6/141 (4.26%)  2/141 (1.42%)  5/143 (3.50%) 
Nervous system disorders         
Headache  1  7/142 (4.93%)  2/141 (1.42%)  6/141 (4.26%)  2/143 (1.40%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  4/142 (2.82%)  1/141 (0.71%)  3/141 (2.13%)  2/143 (1.40%) 
Dyspnoea  1  2/142 (1.41%)  2/141 (1.42%)  4/141 (2.84%)  4/143 (2.80%) 
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00570778     History of Changes
Other Study ID Numbers: CQVA149A2204
First Submitted: December 10, 2007
First Posted: December 11, 2007
Results First Submitted: October 23, 2012
Results First Posted: February 28, 2013
Last Update Posted: July 25, 2018