Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
Brief Summary: This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Options:
A: Inclusion Criteria:

* Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
* In addition the following inclusion/exclusion criteria specified below must be met.

  1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).
  2. Written informed consent to participate in the extension must be obtained.
  3. Patients must be able to comply with all study requirements.

Exclusion Criteria:

* Patients who were randomized to open-label tiotropium in Study B2335S.
* Patients who participated in Stage 1 of the core study (B2335S).
* Patients discontinued irrespective of the reason from Stage 2 of the core study.
* Patients who fail to comply with the core protocol requirements and procedures.
* Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
* Patients who in the Investigator's opinion should not participate in the extension study.

Other protocol-defined inclusion/exclusion criteria may apply
B: 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.
C: 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.
D: Inclusion Criteria:

* Adults aged ≥ 40 years
* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

  1. Smoking history of at least 10 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 received systemic corticosteroids 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 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.

Answer: C