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...
Date First Received: April 17, 2008
Last Updated: August 18, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, August 2008
Clinical Trial Phase: Phase 3 | Start Date: April 2008
Overall Status: Recruiting
Estimated Enrollment: 1808
Brief Summary
Official Title: “1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: March 2010
Intervention(s) in this Clinical Trial
- Drug: Tiotropium/Salmeterol
- Tiotropium/Salmeterol 7.5/25 mcg
- Drug: Tiotropium
- Tiotropium 18 mcg
- Drug: Salmeterol
- Salmeterol 25 mcg
Outcome Measures for this Clinical Trial
Primary Measures
- Trough FEV1 response
FEV1AUC 0 8h response
Mahler TDI focal score
SGRQ total score
Time to first moderate to severe COPD exacerbation
- Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
- Time Frame: 12 Weeks, 24 Weeks and 48 Weeks
Secondary Measures
- Trough FVC response
FVCAUC 0 8h response
PEF
use of rescue medication
COPD related night time awakenings
- Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks
- Time Frame: 4 Weeks, 12 Weeks, 24 Weeks 36 Weeks and 48 Weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals
Overall Contact: Boehringer Ingelheim Study Coordinator clintriage@boehringer-ingelheim.com
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662740
Study ID Number: 1184.14
ClinicalTrials.gov Identifier: NCT00662740
Health Authority: Spain: Spanish Agency of Medicines
Clinical Trials Authorship and Review
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