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The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT00620022
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : August 17, 2011
Last Update Posted : August 17, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Indacaterol 300 μg
Drug: Placebo
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indacaterol 300 μg Followed by Placebo Placebo Followed by Indacaterol 300 μg
Hide Arm/Group Description Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. 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. Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. 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.
Period Title: Treatment Period 1
Started 46 43 [1]
Completed 41 37
Not Completed 5 6
Reason Not Completed
Adverse Event             4             6
Subject withdrew consent             1             0
[1]
Of 44 randomized patients, 1 patient discontinued before receiving any study treatment.
Period Title: Treatment Period 2
Started 41 37
Completed 39 35
Not Completed 2 2
Reason Not Completed
Adverse Event             2             2
Arm/Group Title Entire Study Population
Hide Arm/Group Description The entire study population includes the group of patients who received indacaterol 300 μg in the first treatment period followed by placebo in the second treatment period and the group of patients who received placebo in the first treatment period followed by indacaterol 300 μg in the second treatment period. 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 Number of Baseline Participants 89
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
62.8  (8.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
27
  30.3%
Male
62
  69.7%
1.Primary Outcome
Title Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
Hide Description At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.
Time Frame End of each 3 week treatment period (last day of Weeks 3 and 9)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.
Arm/Group Title Indacaterol 300 μg Placebo
Hide Arm/Group Description:
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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 Number of Participants Analyzed 78 73
Least Squares Mean (Standard Error)
Unit of Measure: Seconds
586  (30.3) 475  (31.3)
2.Secondary Outcome
Title Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
Hide Description At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Time Frame End of each 3 week treatment period (last day of Weeks 3 and 9)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified-intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.
Arm/Group Title Indacaterol 300 μg Placebo
Hide Arm/Group Description:
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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 Number of Participants Analyzed 78 77
Least Squares Mean (Standard Error)
Unit of Measure: Liters
2.39  (0.034) 2.25  (0.034)
Time Frame Baseline to the end of the study (Week 9)
Adverse Event Reporting Description Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
 
Arm/Group Title Indacaterol 300 μg Placebo
Hide Arm/Group Description Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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. Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
All-Cause Mortality
Indacaterol 300 μg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Indacaterol 300 μg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/83 (3.61%)   1/84 (1.19%) 
Cardiac disorders     
Angina pectoris  1  0/83 (0.00%)  1/84 (1.19%) 
Injury, poisoning and procedural complications     
Femur fracture  1  1/83 (1.20%)  0/84 (0.00%) 
Road traffic accident  1  1/83 (1.20%)  0/84 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/83 (1.20%)  0/84 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/83 (1.20%)  0/84 (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 5%
Indacaterol 300 μg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/83 (7.23%)   10/84 (11.90%) 
Infections and infestations     
Nasopharyngitis  1  6/83 (7.23%)  6/84 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/83 (1.20%)  5/84 (5.95%) 
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00620022     History of Changes
Other Study ID Numbers: CQAB149B2311
First Submitted: February 8, 2008
First Posted: February 21, 2008
Results First Submitted: July 22, 2011
Results First Posted: August 17, 2011
Last Update Posted: August 17, 2011