Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Aclidinium Bromide at Two Dose Levels vs Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.


Options:
A: 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.
B: Inclusion criteria:

* Diagnosis of COPD.
* Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
* History of at least 1 COPD exacerbation in the 12 months prior to screening.
* Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion criteria:

* Diagnosis of asthma.
* Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
* Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
* Lung resection surgery within 1 year of screening.
* Abnormal and clinically significant ECG findings at screening.
* Other inclusion and exclusion criteria will be evaluated at the first study visit.
C: Inclusion Criteria:

* A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
* Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
* A smoking history of at least 10 pack years

Exclusion Criteria:

* History and/or current clinical diagnosis of asthma
* History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
D: Inclusion Criteria:

1. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1:

   Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 \<=70% of predicted normal and FEV1 \<=70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC.

   For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females:FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres)) - 0.025 x age (years) - 2.60
2. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
3. Male or female patients 40 years of age or older.
4. Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or systemic steroids and/or hospitalisation.
5. Patients must be current or ex-smokers with a smoking history of \>= 10 pack-years. (Patients who have never smoked cigarettes must be excluded.)
6. Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).
7. Patients must be able to inhale medication in a competent manner from the HandiHaler and a metered dose inhaler (MDI).
8. Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol.

Exclusion Criteria:

1. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
2. Patients with a diagnosis of asthma.
3. Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis.
4. Patients with known active tuberculosis.
5. Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically-controlled prostatic hyperplasia on medication may be included and should continue their medication.
6. Patients with known narrow-angle glaucoma.
7. Patients with a history of myocardial infarction within the year prior to Visit 1.
8. Patients with a history of hospital admission for heart failure within the year prior to Visit 1.
9. Patients with cardiac arrhythmia requiring medical or surgical treatment.
10. Patients with severe cardiovascular disorders.
11. Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other component of the medication delivery system.
12. Patients with known moderate or severe renal insufficiency (known creatinine clearance of \<= 50 mL/min).
13. Patients with untreated known hypokalaemia.
14. Patients with untreated known thyrotoxicosis.
15. Patients with brittle/unstable diabetes mellitus.
16. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion 1.
17. Patients who have taken an investigational drug within 30 days or six half-lives (whichever is greater) prior to Screening Visit (Visit 1).
18. Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day.
19. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g Norplant) for at least three months prior to, and for the duration of the trial.
20. Previous participation (receipt of randomised treatment) in this study.
21. Patients who are currently participating in another study.
22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior to the Screening Visit (Visit 1) or during the run-in period should be postponed. In the case of a respiratory infection or COPD exacerbation during the run-in period, the latter may be extended up to four weeks.

Answer: A