Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 μg; Salmeterol 50 μg; Placebo to Indacaterol; Placebo to Salmeterol
Intervention description: Indacaterol 150 μg once daily (o.d) inhaled; Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler; Placebo to Indacaterol inhaled via SDDPI.; Placebo to salmeterol delivered via a proprietary dry powder inhaler
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1002.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled

Summary:

      This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo
      or salmeterol in patients with chronic obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

        Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as
        per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines
        (mandatory) and including:

          -  Smoking history of at least 20 pack years

          -  Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and
             >or= 30% of predicted normal value

          -  Post-bronchodilator FEV1/FVC < 70%

        ("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they
             meet pre-specified definitions of post-menopausal or are using pre-specified
             acceptable methods of contraception

          -  Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in

          -  Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)

          -  Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in
             period

          -  Concomitant pulmonary disease

          -  Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of
             childhood asthma

          -  History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for
             females

          -  Patients who have a clinically significant condition or a clinically relevant
             laboratory abnormality

          -  History of reactions to sympathomimetic amines or inhaled medication

          -  Inability to use the dry powder devices or perform spirometry

          -  Irregular day/night, wake/sleep cycles, e.g. shift workers

          -  Certain medications for COPD and allied conditions such as long acting bronchodilators
             must not be used prior to Visit 1 and for a pre-specified minimum washout period

          -  Patients unable or unwilling to complete a patient diary

        Other protocol-defined inclusion/exclusion criteria may apply.