Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler
Brief Summary: This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.


Options:
A: 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 COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

  * Smoking history of at least 20 pack years
  * Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value.
  * Post-bronchodilator FEV1/FVC \< 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

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)
* Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
* Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
* Patients with a history of asthma (with further criteria)
* Patients with Type I or uncontrolled Type II diabetes
* Patients with contraindications for tiotropium
* 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
* Patients with a history of long QT syndrome or whose QTc interval is prolonged
* Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
* Patients who have had treatment with the investigational drug (with further criteria)
* Patients who have had live attenuated vaccinations within 30 days prior to visit 1, 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
B: Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

* a) Smoking history of at least 10 pack-years
* b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
* c) Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

* Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
* 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
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.
C: Inclusion Criteria:

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

  * Smoking history of at least 10 pack years
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value at screening
  * Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70% at screening

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 h 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 (Fridericia'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.
D: Inclusion Criteria:

* Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 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 volume capacity) \< 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)

     Exclusion Criteria:
* Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
* Patients who 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.
* Patients with a history of certain cardiovascular co-morbid conditions.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Answer: C