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The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
This study is ongoing, but not recruiting participants.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00620022
  Purpose

The study will compare the effect of indacaterol 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 delivered via SDDPI
Drug: Placebo to indacaterol delivered via SDDPI
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness
Drug Information available for: Indacaterol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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)

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Exercise endurance time after 3 weeks of treatment.

Secondary Outcome Measures:
  • Trough inspiratory capacity after 3 weeks of treatment
  • Trough forced expiratory capacity after 3 weeks treatment
  • Evaluation of effect on pulmonary function test whilst at rest and exercising
  • Effect on Borg Dyspnoea and leg discomfort scales during exercise after 3 weeks treatment
  • Effect on patient activity as measured using an actigraphy device after 3 weeks of treatment

Estimated Enrollment: 83
Study Start Date: April 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Indacaterol 300 µg delivered via SDDPI
Indacaterol 300 µg delivered via SDDPI
2: Placebo Comparator Drug: Placebo to indacaterol delivered via SDDPI
Placebo to indacaterol delivered via SDDPI

  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 COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and:

    • Smoking history of at least 20 pack years
    • Post-bronchodilator Forced expriratory 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 Visit 2 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 Visit 2
  • Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2.
  • Patients with contra-indications of cardiopulmonary exercise testing
  • Patients with concomitant pulmonary disease,
  • Patients with a history (up to and including Visit 2) 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 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 may apply
  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
Jette, Belgium
Novartis Investigator Site
Gembloux, Belgium
Novartis Investigator Site
Liege, Belgium
Canada
Novartis Investigator Site
Kingston, Canada
Novartis Investigator Site
Edmonton, Canada
Denmark
Novartis Investigative Site
Hellerup, Denmark
Novartis Investigator Site
Aarhus, Denmark
Novartis Investigator Site
Hvidovre, Denmark
Novartis Investigative site
Odense, Denmark
Italy
Novartis Investigator Site
Genova, Italy
Novartis Investigator Site
Verona, Italy
Novartis Investigator Site
Pisa, Italy
Spain
Novartis Investigative site
Seville, Spain
Novartis Investigator Site
Zaragoza, Spain
Novartis Investigator Site
Barcelona, Spain
Novartis Investigator Site
Alicante, Spain
Novartis Investigative Site
Madrid, Spain
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharma Novartis Pharma
  More Information

Responsible Party: novartis ( external affairs )
Study ID Numbers: CQAB149B2311
Study First Received: February 8, 2008
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00620022  
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

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009