Clinical trial NCT00096616: Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2004-11-15
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
Secondary outcomes:
measure: FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 620 South 20th Street, NHB 104
state: Alabama
city: Birmingham
country: United States
facility: Cooper Green Hospital
state: Alabama
city: Lakewood
country: United States
facility: Southern California Clinical Trials
state: California
city: Palmdale
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Panama City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Coeur d'Arlene
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Idaho
city: River Forest
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Illinois
city: Olathe
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: LSU MC-Sheveport
state: Louisiana
city: Auburn
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins Asthma & Allergy
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Berlin
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Cherry Hill
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Durham
country: United States
facility: Division of Pulmonary & Critical Care Medicine
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University, Center for Human Genomics
state: North Carolina
city: Hershey
country: United States
facility: Penn State University, Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Houston
country: United States
facility: Ben Taul General Hospital
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Center at Tyler
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
citation: 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.