Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.


Options:
A: Inclusion criteria:

For COPD subjects: Male or female, age of 40 years or older, smoking history \>10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio \<70%., FEV1 \>/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria:

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
B: Inclusion Criteria:

* Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Classifications A-D and stages 1-4.

Exclusion Criteria:

* Considerably reduced health status (severe concomitant disease, which will affect the results of the outcome parameters, for example, cancer or severe cardiac, neurological or orthopaedic comorbidities)
* Considerable reduction of sight and hearing
* Severe psychiatric condition as secondary diagnosis
* Lack of ability to speak German
C: Inclusion Criteria:

* People diagnosed with COPD or diabetes type 2 who are predominantly treated in primary care and who benefit from more physical activity, will be included. -This means patients who do not comply with the Dutch Norm for Healthy Exercise (30 minutes activity per day of a moderate intensity during five days a week)
* Their age should be between 40-70 years to ensure homogeneity in the groups
* Additional inclusion criteria for the diabetes group are a recent (no longer than a year ago) HbA1c concentration of more than 7% / more than 53 mmol/mol and a body mass index of more than 25kg/m2

For the COPD group the following additional inclusion criteria apply:

-A clinical diagnosis of COPD according to the GOLD-criteria stage 1, 2 and 3 (post bronchodilator FEV1/IVC \<= 70% and FEV1 between 30 and 80% of the predicted value); at least six weeks respiratory stable and on a stable drug regimen

Exclusion Criteria:

-Patients older than 70 years are not included because of a bigger risk for co-morbidity and a higher chance of mobility problems (balance)
D: Inclusion Criteria:

* clinical diagnosis of a chronic respiratory disease
* clinically stable in the previous month
* ≥ 18 years old
* able to provide their own informed consent

Exclusion Criteria:

* cognitive impairments
* inability to understand and co-operate
* history of neoplasic /immunologic disease or acute cardiac condition or a significant cardiac, musculoskeletal, neuromuscular or psychiatric condition.

Answer: A