Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female patients with moderate to severe stable COPD:
* Patients with a diagnosis of chronic bronchitis and/or emphysema
* FEV1 \<65% of predicted value without regard to prior treatment
* Forced expiratory ration (FER = FEV1/VC) \<70% of predicted value without regard to prior treatment
* Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial
* Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
Patient aged ≥40 years
Patients with a smoking history of ≥15 pack-years
Patients must have given informed consent to participate in the trial
You may not be if
Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
Patients with any of the following:
* untreated angle closure glaucoma
* hypertrophic obstructive cardiomyopathy
* tachyarrhythmia
* recent myocardial infarction (within six months of screening visit)
* severe organic cardiac or vascular disorder
* untreated hyperthyroidism
* diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)
Patients who are pregnant, or who are planning a pregnancy, and nursing mothers
Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
Patients known to abuse drugs or alcohol
Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
Patients with a PaO2 (arterial carbon dioxide tension) \<56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
Patients who are taking part in another investigation, and patients who have participated in another clinical trial during the three months immediately preceding entry to this trial
Patients on home oxygen concentrator therapy
Patients who have previously participated in the randomised phase of this trial
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