A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Tiotropium; Placebo
Intervention description: Indacaterol 150 μg or 300 μg, delivered via SDDPI; Tiotropium 18 μg once daily delivered via inhalation device; Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhalation device (HandiHaler®)
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 169.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled

Summary:

      The study compared the 24-hour spirometry profile of indacaterol with that of placebo and
      with tiotropium as an active control in patients with 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 out patients with a 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 10 pack years (current or previous smokers)

               2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥30% of
                  the predicted normal value.

               3. Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%

        Exclusion Criteria:

          -  Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to
             Visit 1 or during the run-in period

          -  Patients requiring long-term oxygen therapy for chronic hypoxemia

          -  Patients who have had a respiratory tract infection within 6 weeks prior to Visit

          -  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 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, MDI or perform
             spirometry measurements

        Other protocol-defined inclusion/exclusion criteria may apply.