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NCT Number: NCT00620022

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigator Site, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indacaterol 300 μg

Drug

Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Placebo

Drug

Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Aug 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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