Please select the eligibility criteria that correspond to the clinical trial below.
Title: Spiriva® Assessment of FEV1 (SAFE). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Long-term Treatment in Patients With COPD. A One-year Parallel Group, Double-blind, Randomised, Placebo-controlled Study
Brief Summary: The objective of this trial is to evaluate whether the effect of one year (48 weeks) treatment with inhaled tiotropium bromide (Spiriva® - 18 µg once daily) on the change in trough FEV1, compared to placebo in patients with COPD, is affected by smoking status.


Options:
A: Inclusion Criteria:

* Diagnosis of COPD
* Stable airway obstruction
* FEV1 \< or equal to 65% of predicted
* Male or female
* Age \> or equal to 40 years
* \> or equal to 10 pack year smoking history
* History of exacerbations in the past year
* Able to be trained in the proper use of the HandiHaler®

Exclusion Criteria:

* History of asthma
* Allergic rhinitis or atopy
* Unstable use (6 weeks) of OCS (or \> 10 mg daily use)
* History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis
* Patients who had started or stopped an exercise rehabilitation program in the past twelve months
* Thoracotomy with pulmonary resection or lobectomy (LVRS)
* Active tuberculosis
* Use of beta-blockers
* Pregnant, nursing women and women of childbearing potential not using a medically approved means of contraception
* 6 months or less history of myocardial infarction
* Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system
* History of unstable arrhythmia with a life threatening event or change of related therapy during the past year
* History of cancer, other than treated basal cell carcinoma, within the last 12 months
* Clinically relevant abnormal baseline haematology, blood chemistry or urinalysis
* Patients with narrow angle glaucoma
* Patients with symptomatic benign prostatic hypertrophy
* Patients with bladder neck obstruction
* Patients that planned to be out of the country for 8 weeks or more
B: Criteria

* Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.
C: 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.
D: Inclusion criteria

1. All patients must sign an informed consent
2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)
3. Age \>= 40 years
4. Medical Research Council Dyspnoea score \>= 2
5. Current or ex-smoker with a \>= 10 pack-year smoking history
6. Ability to exercise on treadmill

Exclusion criteria

1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
2. Clinical history of asthma
3. Use of supplemental oxygen therapy
4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
5. Recent history (\<= 12 months) of myocardial infarction
6. Unstable or life-threatening cardiac arrhythmia
7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years
8. Pregnant or nursing women
9. Known hypersensitivity to anticholinergic drugs or any component of the study medications
10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
11. Estimated life expectancy \< 2 years
12. Symptomatic prostatic hyperplasia or bladder neck obstruction
13. Known narrow-angle glaucoma
14. Any condition that is contraindicated for exercise
15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
16. Body mass index \< 18 kg/m2 or \>35 kg/m2 list truncated for space

Answer: A