The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 300 μg; Placebo
Intervention description: Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.; Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: indacaterol; chronic obstructive pulmonary disease; exercise endurance; moderate to severe chronic obstructive pulmonary disease; COPD

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.
    

Eligibility 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.