A Crossover Study in the Treatment of Patients With COPD
1 other identifier
interventional
100
1 country
15
Brief Summary
The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol \[2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID\], and to Compare the preference/compliance of BID nebulization to QID use of MDI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease
Started May 2007
Shorter than P25 for phase_3 chronic-obstructive-pulmonary-disease
15 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
April 17, 2007
CompletedFirst Posted
Study publicly available on registry
April 19, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMarch 4, 2009
March 1, 2009
4 months
April 17, 2007
March 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lung function after 2 weeks of treatment
Secondary Outcomes (2)
Lung function at each time point, patient questionnaires, medication compliance,
adverse events, clinical labs, vital signs, ECGs, physical exams
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD
- Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
- Meet lung function requirements
You may not qualify if:
- Diagnosis of Asthma
- Significant disease other than COPD
- Female pregnant or lactating or planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (15)
Research Site
San Diego, California, 92120, United States
Research Site
Denver, Colorado, 80206, United States
Research Site
Wheat Ridge, Colorado, 80033, United States
Research Site
Panama City, Florida, 32405, United States
Research Site
Pensacola, Florida, 32504, United States
Research Site
Coeur d'Alene, Idaho, 83814, United States
Research Site
Sunset, Louisiana, 70584, United States
Research Site
Charlotte, North Carolina, 28207, United States
Research Site
Portland, Oregon, 97213, United States
Research Site
Gaffney, South Carolina, 29340, United States
Research Site
Spartanburg, South Carolina, 29303, United States
Research Site
Johnson City, Tennessee, 37601, United States
Research Site
San Antonio, Texas, 78205, United States
Research Site
Spokane, Washington, 99204, United States
Research Site
Morgantown, West Virginia, 26505, United States
Related Publications (1)
Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185/03007990802708152.
PMID: 19232039RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 17, 2007
First Posted
April 19, 2007
Study Start
May 1, 2007
Primary Completion
September 1, 2007
Study Completion
October 1, 2007
Last Updated
March 4, 2009
Record last verified: 2009-03