Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.


Options:
A: Inclusion Criteria:

Clinically stable patients with COPD will be recruited from the academic centers' Outpatient Clinic on the following entry criteria:

1. a post-bronchodilator forced expiratory volume in one second (FEV1) \<70% predicted without significant reversibility (\<12% change of the initial FEV1 value or \<200 ml) and
2. optimal medical therapy according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) (6).

Exclusion Criteria:

1. Orthopedic, neurological, and other musculoskeletal complaints that could impair normal movement patterns,
2. respiratory diseases other than COPD (e.g. asthma),
3. hospital admission or COPD exacerbations within the previous 4 weeks
4. patients not on optimal pharmacotherapy.
B: 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 moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), and:

  * Smoking history of at least 20 pack years.
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value.
  * Post-bronchodilator FEV1/forced vital capacity (FVC) \< 70%.

Exclusion Criteria:

* Pregnant or nursing (lactating) women.
* Women of child-bearing potential.
* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
* Patients requiring oxygen therapy or who experience oxygen desaturation to \< 80% during cycle exercise on room air.
* Patients with a Wmax value \< 20 W (as determined by the incremental cycle endurance test) at screening.
* Patients who have had a respiratory tract infection within 6 weeks prior to screening.
* Patients with contra-indications of cardiopulmonary exercise testing.
* Patients with concomitant pulmonary disease.
* Patients with a history (up to and including the screening visit) 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 the collection of informed consent visit (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, metered dose inhaler (MDI), or perform spirometry measurements.

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

* COPD
* able to ambulate
* internet access

Exclusion Criteria:

* current pulmonary rehab
D: Inclusion Criteria:

* Male or female, aged more than 35 years
* Physician labelled diagnosis of COPD, emphysema or chronic bronchitis
* Ex or current smoker of more than 20 pack years
* FEV1 less than 80% of predicted
* Patients may be taking long or short acting bronchodilators and/or inhaled or oral corticosteroids and/or theophyllines.
* Patients having attended at least 60% of the exercise sessions in the initial PR(22)\* \* This is an inclusion criterion for randomisation to receive maintenance PR or standard medical care but not entry into the study

Exclusion Criteria:

* Significant cardiac or pulmonary disease other than COPD such that COPD is the minor contribution to the patients' symptoms.
* Myocardial infarction within the previous 6 months or unstable angina
* Respiratory infection defined as cough, antibiotic use or purulent sputum within 4 weeks prior to randomisation.
* Severe or uncontrolled co-morbid disease, which is likely to affect the outcome of the study.
* Abnormalities in cognitive functioning that would limit the patient's ability to undertake the procedures required in the study.
* Unable to give written informed consent.

Answer: B