Study of Indacaterol Dosed in the Evening 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; Salmeterol; Placebo to Indacaterol; Placebo to Salmeterol
Intervention description: 300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI); 50 µg twice daily delivered via dry powder inhaler (DPI); Placebo matching indacaterol was delivered via SDDPI.; Placebo matching salmeterol was delivered via DPI
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 96.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, bronchodilator, long acting beta agonist, LABA

Summary:

      This study was conducted to provide detailed information on the efficacy of indacaterol (in
      terms of the spirometry assessment forced expiratory volume in 1 second [FEV1]) over the full
      24-h time period
    

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 chronic obstructive pulmonary disease
             (COPD) (moderate to severe as classified by the Global initiative for chronic
             obstructive lung disease (GOLD) Guidelines, 2006) and:

          -  Smoking history of at least 20 pack years

          -  Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value

          -  Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%

        Exclusion criteria:

          -  Pregnant or lactating females

          -  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 (>15 h a day)

          -  Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further
             criteria)

          -  Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically
             significant bronchiectasis

          -  Patients with history of asthma (with further criteria)

          -  Patients with Type I or uncontrolled type II diabetes.

          -  Patients who have clinically relevant laboratory abnormalities or a clinically
             significant abnormality

          -  Any patient with active cancer or a history of cancer with less than 5 years disease
             free survival time

          -  Patient with a history with long QT syndrome or whose QTc interval is prolonged

          -  Patients with a hypersensitivity to any of the study drugs or drugs with similar
             chemical structure

          -  Patients who have had treatment with an investigational drug (with further criteria)

          -  Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or
             during run-in period

          -  Patients with known history of non compliance to medication

          -  Patients unable to satisfactorily use a dry powder inhaler device or perform
             spirometry measurements

        Other protocol-defined inclusion/exclusion criteria may apply