Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 μg capsules; Indacaterol 300 μg capsules; Placebo capsules
Intervention description: Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Indacaterol was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Placebo was supplied in powder filled capsules with a single dose dry powder inhaler (SDDPI).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 347.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; chronic obstructive pulmonary disease; indacaterol; long acting β2-agonist

Summary:

      This study was designed to provide pivotal confirmation of efficacy and safety data for 2
      doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe
      chronic obstructive pulmonary disease (COPD). Data from this study will be used for the
      registration of indacaterol in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as
             classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
             guidelines and:

               1. Smoking history of at least 20 pack-years.

               2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30%
                  of the predicted normal value.

               3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%.

        Exclusion Criteria:

          -  Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to
             screening or during the 14 day run-in period prior to randomization.

          -  Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia.

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening.

          -  Patients with concomitant pulmonary disease.

          -  Patients with a history 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 screening 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 or perform spirometry
             measurements.

        Other protocol-defined inclusion/exclusion criteria applied to the study.