Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
Brief Summary: The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.


Options:
A: Inclusion Criteria:

* mild to very severe COPD.
* age ≥ 45 years of age with no other major healthproblems.
* clinically stable at the time of enrollment into the study.
* insomnia.

Exclusion criteria:

* evidence of restrictive lung disease or asthma.
* pulse oximetry reading of \< 90% at rest or \< 85% at night for \> 5 min.
* evidence of a major sleep disorder other than insomnia.
* hypnotic use.
* acute respiratory infection within the previous 2 months.
* presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis; evidence of alcohol or drug abuse, musculoskeletal or degenerative nerve disease.
* a self-reported current diagnosis of major depression or psychiatric disease or a Hospital Anxiety and Depression Scale (HADS) depression score of \> 11.
* currently participating in pulmonary rehabilitation.
B: Inclusion Criteria:

* COPD GOLD grade II or higher with a prior history of exacerbations and/or an hospitalization for COPD in the previous year with one or more documented non-pulmonary chronic conditions such as:
* CHF due to left ventricular systolic dysfunction (LVSD) confirmed on echocardiography
* SDB identified by respiratory sleeping studies or polysomnography
* current or prior smoking history of \>= 10 pack/years
* subjects capable of providing signed written informed consent
* subjects capable of perform study procedures and use the RESMONPRO at home
* subjects with reliable mobile phone coverage at home

Exclusion Criteria:

* Any disease that, in the opinion of the investigator, put the subject at risk
* subjects with significant vision disturbance and mental diseases
* subjects with a planned prolonged absence from home
C: Inclusion Criteria:

* patients aged 65 years and older
* must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year
* must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires)

Exclusion Criteria:

* patients with both confirmed COPD and heart failure (Spirometry performed \< 1 year ago and heart failure confirmed by echocardiography)
* patients unable or unwilling to sign informed consent
D: 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

Answer: D