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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

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.