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

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)

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.

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.