Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease
Brief Summary: This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).


Options:
A: Inclusion Criteria:

* At least 40 years of age and no older than 80 at Screening
* Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit
* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
* Current or former smokers with a history of at least 10 pack-years of cigarette smoking
* Pre- and post-bronchodilator FEV1/FVC ratio of \<0.70
* Post-bronchodilator FEV1 must be \<80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 \<30% of predicted normal value

Exclusion Criteria:

* Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
* Women who are pregnant or lactating
* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma
* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period
* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period
* Subjects who have clinically significant uncontrolled hypertension.
* Subjects who have cancer that has not been in complete remission for at least five years
* Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing
* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible
* Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study
* Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
B: Inclusion Criteria:

* Co-operative males or females with a diagnosis of moderate COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria with an age at onset ≥ 40 years.
* Current or previous smokers with a smoking history of ≥ 10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
* Pre-bronchodilator forced expiratory volume in one second (FEV1) \< 70% of patient's predicted normal value and ≥ 1.00 L, with FEV1/forced vital capacity (FVC) \< 70% at Visit 2.
* A total symptom score from the patient diary of more than 0 on at least 4 of the last 7 days prior to Visit 3

Exclusion Criteria:

* Pregnant women, nursing mothers, and females of childbearing potential, regardless of whether or not sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception).
* Patients who have been hospitalized for an acute exacerbation of their airway diseases in the month prior to Visit 1 or during screening.
* Patients who have had a respiratory tract infection within 1 month prior to Visit 1. Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection).
* Patients with concomitant pulmonary disease including a history of cancer (all), pulmonary tuberculosis or congenital bronchiectasis.
* History of asthma
C: Inclusion criteria:

* Diagnosis chronic obstructive pulmonary disease
* Relatively stable airway obstruction with post FEV1 \>=30 and \< 80% predicted normal and post FEV1/ FVC \< 70%
* Male or female patients, 40 years of age or more
* Smoking history more than 10 pack years

Exclusion criteria:

* Significant diseases other than COPD
* History of asthma
* COPD exacerbation in previous 3 months
* Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
* Pregnant or nursing women
* Patients unable to comply with pulmonary medication restrictions
D: Inclusion Criteria:

* outpatient
* signed and dated written informed consent
* 40 years of age or older
* male and female subjects
* COPD diagnosis
* at least 10 pack-year smoking history
* post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 and post-albuterol/salbutamol FEV1 of less than or equal to 70% predicted normal values
* score of greater than or equal to 2 on the Modified Medical Resarch Council Dyspnea Scale (mMRC)

Exclusion Criteria:

* women who are pregnant or lactating or are planning on becoming pregnant during the study
* current diagnosis of asthma
* other respiratory disorders other than COPD
* other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
* chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
* hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
* hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
* lung volume reduction surgery within 12 months prior to Visit 1
* abnormal and clinically significant ECG at Visit 1
* significantly abnormal finding from laboratory tests at Visit 1
* unable to withhold albuterol/salbutamol at least 4 hours prior to spirometry at each visit
* use of depot corticosteroids within 12 weeks of Visit 1
* use of oral or parenteral corticosteroids, antibiotics for lower respiratory tract infection, or cytochrome P450 3A4 inhibitors, within 6 weeks of Visit 1
* use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if LABA/ICS therapy is discontinued withing 30 days of Visit 1
* use of ICS at a dose of \>1000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
* initiation or discontinuation of ICS within 30 days of Visit 1
* use of tiotropium or roflumilast within 14 days of Visit 1
* use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
* short-acting oral beta-agonists within 12 hours of Visit 1
* use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
* use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
* use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-agonist combination products within 4 hours of Visit 1
* use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer)
* long-term oxygen therapy prescribed for \>12 hours per day
* regular use of nebulized short-acting bronchodilators
* participation in acute phase of pulmonary rehabilitation program
* known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
* anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
* previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination

Answer: B