Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-week Study to Evaluate the 24-hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of FF/VI 100/25mcg once daily compared with Fluticasone Propionate/Salmeterol 250/50mcg twice daily over a 12-week treatment period in subjects with COPD.


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)

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:

* Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
* Post-salbutamol (FEV1) \< 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
* Current or ex-smokers of ≥10 pack-years.

Exclusion Criteria:

* Patients with no history or current diagnosis of asthma.
* No evidence of an exacerbation within 6 weeks prior to the screening visit.
* No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
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:

* All patients must have a diagnosis of chronic obstructive pulmonary disease
* Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 \<80% predicted and post-bronchodilator FEV1/FVC \<70%

Exclusion criteria:

* Patients with a significant disease other than COPD
* Patients with a history of asthma
* Patients with any of the following conditions:

a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis

Answer: A