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 bt the SGRQ and the effect on COPD...
Date First Received: April 17, 2008
Last Updated: October 30, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, October 2008
Clinical Trial Phase: Phase 3 | Start Date: April 2008
Overall Status: Terminated
Estimated Enrollment: 205
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 bt the SGRQ and the effect on COPD exacerbations
Study Type: Interventional
Study Design: Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: October 2008
Intervention(s) in this Clinical Trial
- Drug: Tiotropium/Salmeterol
- Drug: Tiotropium
- Drug: Salmeterol
Outcome Measures for this Clinical Trial
Primary Measures
- Trough FEV1 response
FEV1AUC 0 8hr 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
- Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year
- Hospitalisation for cardiac failure during the 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
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668772
Study ID Number: 1184.15
ClinicalTrials.gov Identifier: NCT00668772
Health Authority: Brazil: National Health Surveillance Agency
Clinical Trials Authorship and Review
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