Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-week Double-blind, Randomised, Parallel-group, Multi-centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD, According to Swedish Guidelines (SPIRIMILD)
Brief Summary: To show that treatment with tiotropium inhalation capsules (18 μg q.d.) via HandiHaler® improves lung function in patients with mild COPD according to Swedish guidelines.


Options:
A: Inclusion Criteria:

1. Male or female
2. At least 40 years old
3. Smoker or ex-smoker
4. Smoking history \> 10 pack-years
5. Forced Expiratory Volume in 1 Second (FEV1) \< 60% predicted

Exclusion Criteria:

1. Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
2. History of asthma or allergic conditions.
3. Malignancy requiring treatment within past 5 years
4. Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
5. Known active tuberculosis
6. Known hypersensitivity to anticholinergic drugs.
B: Inclusion Criteria:

1. Patients who have signed an written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial.
2. Patients with a diagnosis of COPD. COPD is defined as a disease state characterised by the presence of airflow obstruction often due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyperreactivity, and may be partially reversible.
3. Patients 40 years of age or older without any restriction to sex.
4. Patients who currently smoke or who are ex-smokers with a cigarette smoking history of \>10 pack-years.
5. Patients who have a relatively stable airway obstruction (at least 4 weeks free of COPD exacerbations) with a post bronchodilator FEV1 ? 60% of predicted normal, a post bronchodilation FEV1 \< 70% of FVC, and a MRC symptom score minimum of 2 at Visit 1

Exclusion Criteria:

1. Patients with a history of asthma, allergic rhinitis, atopy, or who have a total (absolute) blood eosinophil count ? 600 per mm3 (= 0.6 \* 109/L) of the first determination at Visit 1
2. Patients with known moderate or severe renal insufficiency.
3. Patients with a recent history (i.e., 6 months or less prior to Visit 1) of myocardial infarction.
4. Patients with any unstable or life threatening cardiac arrhythmia, including patients with a newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed at Visit 1 as well as patients with cardiac arrhythmia requiring an intervention (i.e., hospitalisation, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year prior to Visit 1.
5. Patients who regularly use oxygen therapy.
6. Patients with known active tuberculosis.
7. Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed.
8. Patients with a history of life threatening pulmonary obstruction or a history of cystic fibrosis or clinically evident bronchiectasis.
9. Patients who have undergone thoracotomy with pulmonary resection.
10. Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
11. Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
12. Patients with known symptomatic hyperplasia or bladder neck obstruction. Patients being treated for prostatic hyperplasia and report minimal symptoms may be included and should continue their medications.
13. Patients with known narrow-angle glaucoma.
C: Inclusion Criteria:

* History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
* Smoking history greater than or equal to 10 pack years
* Not history of clinical diagnosis of asthma and/or atopy
* A history of thoracotomy with pulmonary resection
* Patients requiring the use of supplemental oxygen therapy for \>12 hours per day
* Chronic use of systemic corticosteroids in an unstable daily dose
* Patients with a recent history of myocardial infarction
* A known hypersensitivity to anticholinergic drugs
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: B