Status:
TERMINATED
Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea...
Eligibility Criteria
Inclusion
- Main Inclusion criteria:
- Diagnosis of COPD
- Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted
- Main Exclusion criteria:
- Significant other diseases then COPD
- Recent myocardial infarction (MI)
- Unstable or life-threatening arrythmia requiring intervention or change in drug therapy
- Hospitalisation for cardiac failure in past year
- History of asthma
Exclusion
Key Trial Info
Start Date :
April 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2008
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00662740
Start Date
April 15 2008
End Date
November 21 2008
Last Update
August 23 2023
Active Locations (72)
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1
1184.14.01013 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
2
1184.14.01018 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
3
1184.14.01006 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
4
1184.14.01003 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States