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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00620022
First received: February 8, 2008
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Indacaterol 300 μg
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Drug Information available for: Indacaterol
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Indacaterol 300 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
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.
 Drug: Indacaterol 300 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Drug: Placebo
Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620022

Locations
United States, California
Novartis Investigator Site
Torrance, California, United States
United States, New Hampshire
Novartis Investigator Site
Lebanon, New Hampshire, United States
Belgium
Novartis Investigator Site
Bruxelles, Belgium
Novartis Investigator Site
Gembloux, Belgium
Novartis Investigator Site
Jette, Belgium
Novartis Investigator Site
Liege, Belgium
Canada
Novartis Investigator Site
Edmonton, Canada
Novartis Investigator Site
Kingston, Canada
Denmark
Novartis Investigator Site
Aarhus, Denmark
Novartis Investigative Site
Hellerup, Denmark
Novartis Investigator Site
Hvidovre, Denmark
Novartis Investigative site
Odense, Denmark
Italy
Novartis Investigator Site
Genova, Italy
Novartis Investigator Site
Pisa, Italy
Novartis Investigator Site
Verona, Italy
Spain
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
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00620022     History of Changes
Other Study ID Numbers: CQAB149B2311
Study First Received: February 8, 2008
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
indacaterol
chronic obstructive pulmonary disease
exercise endurance
moderate to severe chronic obstructive pulmonary disease
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013