Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids
1 other identifier
interventional
113
1 country
27
Brief Summary
The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
27 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
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 12, 2004
CompletedFirst Posted
Study publicly available on registry
November 15, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedNovember 1, 2013
October 1, 2013
1.3 years
November 12, 2004
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
Secondary Outcomes (1)
FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
Interventions
Eligibility Criteria
You may qualify if:
- Patient greater than or equal to 18 years of age,
- non-smokers,
- diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
- stable use of Beta agonist
- daily use of inhaled steroids for one year
You may not qualify if:
- Patients with other significant diseases other than asthma, requiring oxygen,
- intubated within 5 years,
- asthma exacerbation within 6 weeks of trial,
- use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
- participating in another interventional trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
620 South 20th Street, NHB 104
Birmingham, Alabama, United States
Cooper Green Hospital
Birmingham, Alabama, United States
Southern California Clinical Trials
Lakewood, California, United States
Boehringer Ingelheim Investigational Site
Palmdale, California, United States
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
University of Miami School of Medicine
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
Boehringer Ingelheim Investigational Site
Coeur d'Arlene, Idaho, United States
Boehringer Ingelheim Investigational Site
River Forest, Illinois, United States
Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
LSU MC-Sheveport
Shreveport, Louisiana, United States
Boehringer Ingelheim Investigational Site
Auburn, Maine, United States
Johns Hopkins Asthma & Allergy
Baltimore, Maryland, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Boehringer Ingelheim Investigational Site
Berlin, New Jersey, United States
Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey, United States
North Shore University Hospital
Manhasset, New York, United States
NYU School of Medicine
New York, New York, United States
Division of Pulmonary & Critical Care Medicine
Durham, North Carolina, United States
Wake Forest University, Center for Human Genomics
Winston-Salem, North Carolina, United States
Penn State University, Hershey Medical Center
Hershey, Pennsylvania, United States
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Ben Taul General Hospital
Houston, Texas, United States
University of Texas Health Center at Tyler
Tyler, Texas, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Related Publications (1)
Gelb AF, Karpel J, Wise RA, Cassino C, Johnson P, Conoscenti CS. Bronchodilator efficacy of the fixed combination of ipratropium and albuterol compared to albuterol alone in moderate-to-severe persistent asthma. Pulm Pharmacol Ther. 2008 Aug;21(4):630-6. doi: 10.1016/j.pupt.2008.02.005. Epub 2008 Mar 5.
PMID: 18403223DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 12, 2004
First Posted
November 15, 2004
Study Start
November 1, 2004
Primary Completion
March 1, 2006
Last Updated
November 1, 2013
Record last verified: 2013-10