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:

* Signed and dated written informed consent
* Male or females ≥ 40 years of age
* Established clinical history of COPD by ATS/ERS definition
* Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in protocol, used consistently and correctly
* Former or current smoker \> 10 pack years
* Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≤ 70% of predicted normal (NHANES III)
* have been hospitalised or have been treated with oral corticosteroids or antibiotics for their COPD within the last 3 years prior to Screening (Visit 1)

Exclusion Criteria:

* Current diagnosis of asthma
* Subjects with other respiratory disorders including active tuberculosis, α1-antitrypsin deficiency, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
* Lung volume reduction surgery within previous 12 months
* Clinically significant abnormalities not due to COPD by chest x-ray
* Hospitalized for poorly controlled COPD within 12 weeks of Screening
* Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician
* Lower respiratory infection requiring antibiotics 6 weeks prior to Screening
* Uncontrolled or clinically significant (in opinion of PI) cardiovascular, hypertension, neurological, psychiatric, renal, hepatic, immunological, endocrine, peptic ulcer disease, or hematological abnormalities
* Carcinoma not in complete remission for at least 5 years
* Subjects with history of hypersensitivity to study medications (e.g., beta-agonists, corticosteroid) or components of inhalation powder (e.g., lactose, magnesium stearate)
* Subjects with history of severe milk protein allergy that, in opinion of study physician, contraindicates subject's participation - Known/suspected history of alcohol or drug abuse in the last 2 years
* Women who are pregnant or lactating or plan to become pregnant
* Subjects medically unable to withhold albuterol and/or ipratropium 4 hours prior to spirometry testing at each study visit
* Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)
* Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy \>12 hours a day
* Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study - Non-compliance or inability to comply with study procedures or scheduled visits
* Affiliation with investigator site
B: Inclusion Criteria:

* Diagnosis of COPD
* 10 pack-year or greater history of cigarette smoking
* Post-bronchodilator FEV1/FVC of \<0.7
* Predicted FEV1 of 70% of normal or less
* Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

Exclusion Criteria:

* Women who are pregnant, lactating, or planning to become pregnant
* Respiratory disorders other than COPD, including a current diagnosis of asthma
* Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled
* Significant allergy or hypersensitivity to anticholinergics, beta-agonist, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
* Hospitalization for COPD or pneumonia within 12 weeks prior to screening
* Lung volume reduction surgery within 12 weeks prior to screening
* Abnormal and clinically significant ECG findings at screening
* Clinically significant laboratory findings at screening
* Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (\>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
* Use of long-term oxygen therapy (12 hours or greater per day)
* Regular use of nebulized treatment with short-acting bronchodilators
* Participation in the acute phase of a pulmonary rehabilitation program
* A know or suspected history of alcohol or drug abuse
* Affiliation with the investigational site
* Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW64244
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:

* Male or female adults aged 40 years or older
* Patients with moderate to severe COPD according to the GOLD Guidelines (2006)
* Patients who have smoking history of at least 10 pack years
* Patients with a post-bronchodilator Forced Expiratory Volume in One Second (FEV1) equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7 at visit 2
* Written informed consent by the patient prior to initiation of any study-related procedure

Exclusion Criteria:

* Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period (up to visit 3).
* Patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or during the screening period (up to visit 3).
* Patients with a history of asthma indicated by (but not limited to):

Blood eosinophil count \> 400/mm3, onset of symptoms prior to age 40 years.

* Patients with a history of long QT syndrome or whose QTc measured at visit 1 is prolonged (more than 440 ms for males or more than 460 ms for females).
* Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
* Patients who, in the judgment of the investigator have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe renal impairment that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply

Answer: C