Study in Subjects Greater Than 40 Years of Age With COPD
A 6-Week Trial to Compare the Efficacy and Safety of Concomitant Treatment With 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
19
Brief Summary
This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study. The objectives of this study are:
- 1.To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
- 2.To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease
Started Mar 2007
19 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
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 24, 2007
CompletedFirst Posted
Study publicly available on registry
July 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedNovember 11, 2010
July 1, 2009
7 months
July 24, 2007
November 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint will be the standardized area under the curve for FEV1 (FEV1 AUC0-3) over the 3-hour assessment period at End Study (Week 6/ET).
6 weeks
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 (19)
Clinical Research Site
Mobile, Alabama, 36695, United States
Clinical Research Site
Phoenix, Arizona, 85006, United States
Clinical Research Site
DeLand, Florida, 32720, United States
Clinical Research Site
Atlanta, Georgia, 30330, United States
Clinical Research Site
Livonia, Michigan, 48152, United States
Clinical Research Site
Saint Charles, Missouri, 63301, United States
Clinical Research Site
St Louis, Missouri, 63141, United States
Clinical Research Site
Albany, New York, 12205, United States
Clinical Research Site
North Syracuse, New York, 13212, United States
Clinical Research Site
Williamsville, New York, 14221, United States
Clinical Research Site
Toledo, Ohio, 45560, United States
Clinical Research Site
Medford, Oregon, 97504, United States
Clinical Research Site
Portland, Oregon, 97213, United States
Clinical Research Site
Greenville, South Carolina, 29615, United States
Clinical Research Site
Spartanburg, South Carolina, 29303, United States
Clinical Research Site
San Antonio, Texas, 78229, United States
Clinical Research Site
Abingdon, Virginia, 24210, United States
Clinical Research Site
Richmond, Virginia, 23225, United States
Clinical Research Site
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
Hanania NA, Boota A, Kerwin E, Tomlinson L, Denis-Mize K. Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: Results from a 6-week, randomized, placebo-controlled, clinical trial. Drugs. 2009 Jun 18;69(9):1205-16. doi: 10.2165/00003495-200969090-00005.
PMID: 19537837RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicola A Hanania, MD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 24, 2007
First Posted
July 26, 2007
Study Start
March 1, 2007
Primary Completion
October 1, 2007
Study Completion
April 1, 2008
Last Updated
November 11, 2010
Record last verified: 2009-07