Overview

Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol PE Capsule) in COPD

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined by the SGRQ and the effect on COPD exacerbations.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Salmeterol Xinafoate
Tiotropium Bromide
Criteria
Inclusion criteria:

Main:

Diagnosis of COPD Post-bronchodilator FEV1<80% predicted and FEV1/FVC<70% predicted

Exclusion criteria:

Main:

Significant other diseases then COPD Recent MI Unstable or life-threatening arrythmia
requiring intervention or change in drug therapy Hospitalisation for cardiac failure in
past year History of asthma