Please select the eligibility criteria that correspond to the clinical trial below.
Title: Spiriva Assessment of FEV1 - (SAFE-Portugal). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Treatment in Patients With COPD. A Three-month Parallel Group, Double-blind, Randomised, Placebo-controlled Study.
Brief Summary: Evaluate whether the effect of inhaled tiotropium bromide on the change in trough forced expiratory volume (FEV1), compared to placebo in patients with chronic obstructive pulmonary disease (COPD), is affected by smoking status.


Options:
A: Inclusion Criteria:

* Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between 60 and 79% predicted and FEV 1/FVC \< 70%.
* Smoking history \> 10 pack yr.
* Clinically stable X 6 weeks.
* No oxygen usage.

Exclusion Criteria:

* History of asthma
* Clinically unstable
* Any other significant medical problem precluding full cooperation for study
B: Inclusion Criteria:

* diagnosis of COPD,
* FEV1 \< 80% predicted,
* minimum 10 pack year smoking history

Exclusion Criteria:

* asthma,
* atopic disease,
* eosinophilia,
* history of malignancy,
* history of clinically significant pulmonary disease
C: Main Inclusion criteria: 1.Diagnosis of chronic obstructive pulmonary disease. 2.Patient is male or female, age \<=than 40 years. 3. Patient has a smoking history of \<=10 pack-year.4.Patient is able to be trained in the proper use of HandiHaler 5.Patient is able to be trained to perform technically satisfactory spirometry and must be able to maintain records during the study period as required by the protocol. 6.Patient must be willing and able to sign informed consent prior to participation in the study i.e. prior to washout of their usual pulmonary medications.

Main exclusion criteria 1.History of asthma, allergic rhinitis or atopy. 2. A lower respiratory tract infection or any COPD exacerbation in the past 4 weeks prior to Visit 1 or during the two week Screening Period 3.History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis 4. Oral corticosteroid medication if initiated or modified within the last 6 weeks prior to Visit 1 or if daily dose \> 10 mg prednisone or 20 mg or more every other day (or equivalent). 5.Patients who have started or stopped an exercise rehabilitation program within 4 weeks of visit 6.Patients who regularly use daytime oxygen therapy for more than one hour per day and who, in the investigator's opinion, will be unable to abstain from the use of oxygen therapy during testing. 7. Patients who have undergone thoracotomy with pulmonary resection or lobectomy (lung volume reduction surgery). 8.Tuberculosis with indication for treatment. 9. Recent history (i.e. 6 months or less) of myocardial infarction.10. Patients with known moderate or severe renal insufficiency.11. Patients with symptomatic prostatic hypertrophy or bladder neck obstruction. 12.Patients with known narrow-angle glaucoma.13.History of unstable arrhythmia with a life threatening event or change of therapy during the past year.14. History of cancer, other than treated basal cell carcinoma, within the last 5 years 15.Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system.16.Patients who are being treated with beta-blockers including eye drops.17.Patients who are being treated with antihistamines (H1 receptor antagonists), for asthma or excluded allergic conditions (See Exclusion Criteria No.2).18.Patients who are being treated with monoamine oxidase inhibitors or tricyclic antidepressants.19. Patients who are being treated with oral beta-adrenergics.20. Patients who have taken cromolyn sodium or nedocromil sodium within 1 month of Visit 1.21.Patients who have taken antileukotrienes or leukotriene receptor antagonists within 1 month of Visit 1. 22.Concomitant or recent (within the last month or 6 half lives, whichever is greater) use of investigational drugs prior to the screening visit (Visit 1). 23. Significant alcohol or drug abuse within the past 12 months. 24. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.24. Previous participation in this study (i.e. randomized).26. Patients who have taken commercially available Spiriva. 27.History of any clinically significant disease, defined as a disease which in the opinion of the investigator may the patient at risk because of participation in the study OR a disease which may influence the results of the study OR the patient's ability to participate in the study.
D: Diagnosis of COPD and matching the following criteria:

* Baseline 20 % \< FEV1 \< 70 % of European Community of Coal and Steel (ECCS) predicted values .
* Baseline FEV1/SVC\< 70 %. Smoking history \> 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking one pack of cigarettes per day for one year.

Answer: C