A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD
A 6-Week Double-Blind, Parallel-Group, Active-Controlled Trial to Compare the Efficacy and Safety of Concomitant Treatment of Formoterol Fumarate Inhalation Solution 20 Mcg Twice Daily and Tiotropium 18 Mcg Once Daily to Tiotropium 18 Mcg Once Daily Alone in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
128
1 country
17
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2006
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 29, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 7, 2008
March 1, 2008
1 month
March 27, 2006
March 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of lung Function
Secondary Outcomes (1)
Change in lung function, vital signs; physical examinations; clinical laboratory assessments; adverse event reporting; patient questionnaires
Interventions
Eligibility Criteria
You may qualify if:
- Medical diagnosis of COPD
- Current or prior history of cigarette smoking
You may not qualify if:
- Medical diagnosis of asthma
- Significant condition or disease other than COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (17)
Research Site
Phoenix, Arizona, 85006, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Sepulveda, California, 91343, United States
Research Site
Walnut Creek, California, 94598, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
Tamarac, Florida, 33321, United States
Research Site
Gainesville, Georgia, 30501, United States
Research Site
Auburn, Maine, 04210, United States
Research Site
Ann Arbor, Michigan, 48105, United States
Research Site
Livonia, Michigan, 48152, United States
Research Site
St Louis, Missouri, 63141, United States
Research Site
Liverpool, New York, 13088, United States
Research Site
Rochester, New York, 14618, United States
Research Site
Medford, Oregon, 97504, United States
Research Site
Collegeville, Pennsylvania, 19426, United States
Research Site
El Paso, Texas, 79902, United States
Research Site
San Antonio, Texas, 78229, United States
Related Publications (1)
Tashkin DP, Littner M, Andrews CP, Tomlinson L, Rinehart M, Denis-Mize K. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med. 2008 Apr;102(4):479-87. doi: 10.1016/j.rmed.2007.12.019. Epub 2008 Feb 6.
PMID: 18258423RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 29, 2006
Study Start
April 1, 2006
Primary Completion
May 1, 2006
Study Completion
December 1, 2006
Last Updated
March 7, 2008
Record last verified: 2008-03