Recruitment

Recruitment Status
Completed

Inclusion Criteria

Patients with a diagnosis of chronic bronchitis and/or emphysema
Patient aged ≥40 years
Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
...
Patients with a diagnosis of chronic bronchitis and/or emphysema
Patient aged ≥40 years
Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
Patients with a smoking history of ≥15 pack-years
Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
FEV1 <65% of predicted value without regard to prior treatment
Patients must have given informed consent to participate in the trial
Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial

Exclusion Criteria

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 who are pregnant, or who are planning a pregnancy, and nursing mothers
recent myocardial infarction (within six months of screening visit)
...
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 who are pregnant, or who are planning a pregnancy, and nursing mothers
recent myocardial infarction (within six months of screening visit)
Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
untreated hyperthyroidism
hypertrophic obstructive cardiomyopathy
Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
Patients known to abuse drugs or alcohol
tachyarrhythmia
Patients on home oxygen concentrator therapy
severe organic cardiac or vascular disorder
Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
Patients who have previously participated in the randomised phase of this trial
untreated angle closure glaucoma
Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)

Summary

Conditions
Pulmonary Disease, Chronic Obstructive
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 125 years
Gender
Both males and females

Inclusion Criteria

Patients with a diagnosis of chronic bronchitis and/or emphysema
Patient aged ≥40 years
Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
...
Patients with a diagnosis of chronic bronchitis and/or emphysema
Patient aged ≥40 years
Forced expiratory ration (FER = FEV1/VC) <70% of predicted value without regard to prior treatment
Patients with a smoking history of ≥15 pack-years
Patients must not have changed their normal treatment for COPD during the four weeks immediately prior to entering the trial
FEV1 <65% of predicted value without regard to prior treatment
Patients must have given informed consent to participate in the trial
Patients must not have had a respiratory infection or an exacerbation of COPD during the four weeks immediately prior to entering the trial

Exclusion Criteria

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 who are pregnant, or who are planning a pregnancy, and nursing mothers
recent myocardial infarction (within six months of screening visit)
...
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 who are pregnant, or who are planning a pregnancy, and nursing mothers
recent myocardial infarction (within six months of screening visit)
Patients with a SaO2 ≤85% at rest while breathing air without regard to prior treatment
untreated hyperthyroidism
hypertrophic obstructive cardiomyopathy
Patients with a PaO2 (arterial carbon dioxide tension) <56 mmHg (7.5 kPa) at rest while breathing air without regard to prior treatment
Patients known to abuse drugs or alcohol
tachyarrhythmia
Patients on home oxygen concentrator therapy
severe organic cardiac or vascular disorder
Patients, who in the opinion of the investigator, are likely not to co-operate with any of the requirements of the trial
Patients known to be hypersensitive to anticholinergic drugs or to β2 agonists
Patients who have previously participated in the randomised phase of this trial
untreated angle closure glaucoma
Patients with a diagnosis of asthma, bronchiectasis, cystic fibrosis or bronchiolitis obliterans
diabetes mellitus (after approval of Protocol Amendment 1, the inclusion of well controlled diabetic patients was allowed)

Tracking Information

NCT #
NCT02182856
Collaborators
Not Provided
Investigators
Not Provided
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