The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT ID: NCT00620022
Last Updated: 2011-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2008-04-30
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
Indacaterol 300 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
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.
Indacaterol 300 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Interventions
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Indacaterol 300 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Placebo
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharma
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Novartis Investigator Site
Torrance, California, United States
Novartis Investigator Site
Lebanon, New Hampshire, United States
Novartis Investigator Site
Brussels, , Belgium
Novartis Investigator Site
Gembloux, , Belgium
Novartis Investigator Site
Jette, , Belgium
Novartis Investigator Site
Liège, , Belgium
Novartis Investigator Site
Edmonton, , Canada
Novartis Investigator Site
Kingston, , Canada
Novartis Investigator Site
Aarhus, , Denmark
Novartis Investigative Site
Hellerup, , Denmark
Novartis Investigator Site
Hvidovre, , Denmark
Novartis Investigative site
Odense, , Denmark
Novartis Investigator Site
Genova, , Italy
Novartis Investigator Site
Pisa, , Italy
Novartis Investigator Site
Verona, , Italy
Novartis Investigator Site
Alicante, , Spain
Novartis Investigator Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative site
Seville, , Spain
Novartis Investigator Site
Zaragoza, , Spain
Countries
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References
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O'Donnell DE, Casaburi R, Vincken W, Puente-Maestu L, Swales J, Lawrence D, Kramer B; INABLE 1 study group. Effect of indacaterol on exercise endurance and lung hyperinflation in COPD. Respir Med. 2011 Jul;105(7):1030-6. doi: 10.1016/j.rmed.2011.03.014. Epub 2011 Apr 16.
Other Identifiers
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CQAB149B2311
Identifier Type: -
Identifier Source: org_study_id
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