chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
During twelve weeks a once daily inhalation of studymedication with the
Respimat® inhaler with one of the following treatment arms (randomisation
1:1:1:1) - fixed dose combinatie tiotropium-olodater
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosis chronic obstructive pulmonary disease
 - Relatively stable airway obstruction with post FEV1 >
Exclusion criteria
Exclusion criteria: - Significant diseases other than COPD
 - History of asthma
 - COPD exacerbation in previous 3 months
 - Completion of pulmonary rehabilitation program within previous 6 weeks or current participation in pulmonary rehabilitation program.
 - Pregnant or nursing women
 - Patients unable to comply with pulmonary medication restrictions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are three primary study parameters/ outcome in this study which are analysed after 12 weeks of treatment: * FEV1 AUC0-3h response * Trough FEV1 response, and * SGRQ (total score). This endpoint will be evaluated in this trial as well as after combining the data from this and the replicate trial 1237.26. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secundary study parameters/ outcome in this study which are analysed after 12 weeks of treatment are: * FVC (forced vital capacity) AUC0-3h response (L) * Trough FVC response (L) * FEV1 peak 0-3h response * FVC peak 0-3h response * FEV1 response (L) at 5,15 and 30 minutes, and at 1,2 and 3 hours after inhalation of study medication, and * FVC response (L) at 5,15 and 30 minutes, and at 1,2 and 3 hours after inhalation of study medication. | — |
Countries
Netherlands
Outcome results
None listed