- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00620022
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
July 22, 2011 updated by: Novartis
A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
This study compared the effect of indacaterol (300 μg once daily [od]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bruxelles, Belgium
- Novartis Investigator Site
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Gembloux, Belgium
- Novartis Investigator Site
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Jette, Belgium
- Novartis Investigator Site
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Liege, Belgium
- Novartis Investigator Site
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Edmonton, Canada
- Novartis Investigator Site
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Kingston, Canada
- Novartis Investigator Site
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Aarhus, Denmark
- Novartis Investigator Site
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Hellerup, Denmark
- Novartis Investigative Site
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Hvidovre, Denmark
- Novartis Investigator Site
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Odense, Denmark
- Novartis Investigative Site
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Genova, Italy
- Novartis Investigator Site
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Pisa, Italy
- Novartis Investigator Site
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Verona, Italy
- Novartis Investigator Site
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Alicante, Spain
- Novartis Investigator Site
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Barcelona, Spain
- Novartis Investigator Site
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Madrid, Spain
- Novartis Investigative Site
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Seville, Spain
- Novartis Investigative Site
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Zaragoza, Spain
- Novartis Investigator Site
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California
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Torrance, California, United States
- Novartis Investigator Site
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New Hampshire
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Lebanon, New Hampshire, United States
- Novartis Investigator Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.
Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), and:
- Smoking history of at least 20 pack years.
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value.
- Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%.
Exclusion Criteria:
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
- Patients requiring oxygen therapy or who experience oxygen desaturation to < 80% during cycle exercise on room air.
- Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with contra-indications of cardiopulmonary exercise testing.
- Patients with concomitant pulmonary disease.
- Patients with a history (up to and including the screening visit) of asthma.
- Patients with diabetes Type I or uncontrolled diabetes Type II.
- Any patient with lung cancer or a history of lung cancer.
- Any patient with active cancer or a history of cancer with less than 5 years disease free survival time.
- Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at the collection of informed consent visit (Visit 1) or randomization is prolonged.
- Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
- Patients unable to successfully use a dry powder inhaler device, metered dose inhaler (MDI), or perform spirometry measurements.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Indacaterol 300 μg followed by placebo
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.
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Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
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Experimental: Placebo followed by indacaterol 300 μg
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.
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Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
Time Frame: End of each 3 week treatment period (last day of Weeks 3 and 9)
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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.
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End of each 3 week treatment period (last day of Weeks 3 and 9)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
Time Frame: End of each 3 week treatment period (last day of Weeks 3 and 9)
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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.
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End of each 3 week treatment period (last day of Weeks 3 and 9)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
February 8, 2008
First Submitted That Met QC Criteria
February 20, 2008
First Posted (Estimate)
February 21, 2008
Study Record Updates
Last Update Posted (Estimate)
August 17, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQAB149B2311
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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