A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 300 μg; Placebo to indacaterol; Salmeterol 50 μg
Intervention description: Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).; Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).; Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; indacaterol

Summary:

      This study was conducted to provide detailed information on the efficacy of indacaterol in
      terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a
      24 hour time period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as
             classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
             Guidelines, 2006) 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 run-in period

          -  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.