Asthma Clinical Trial
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
| NCT number | NCT00096616 |
| Other study ID # | 1012.50 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | November 12, 2004 |
| Last updated | October 31, 2013 |
| Start date | November 2004 |
| Verified date | October 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 113 |
| Est. completion date | |
| Est. primary completion date | March 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Boehringer Ingelheim Investigational Site | Auburn | Maine |
| United States | Johns Hopkins Asthma & Allergy | Baltimore | Maryland |
| United States | Boehringer Ingelheim Investigational Site | Berlin | New Jersey |
| United States | 620 South 20th Street, NHB 104 | Birmingham | Alabama |
| United States | Cooper Green Hospital | Birmingham | Alabama |
| United States | Brigham & Women's Hospital | Boston | Massachusetts |
| United States | Boehringer Ingelheim Investigational Site | Charleston | South Carolina |
| United States | Boehringer Ingelheim Investigational Site | Cherry Hill | New Jersey |
| United States | Boehringer Ingelheim Investigational Site | Coeur d'Arlene | Idaho |
| United States | Division of Pulmonary & Critical Care Medicine | Durham | North Carolina |
| United States | Penn State University, Hershey Medical Center | Hershey | Pennsylvania |
| United States | Ben Taul General Hospital | Houston | Texas |
| United States | Southern California Clinical Trials | Lakewood | California |
| United States | University of Wisconsin Hospital | Madison | Wisconsin |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | University of Miami School of Medicine | Miami | Florida |
| United States | NYU School of Medicine | New York | New York |
| United States | Norwalk Hospital | Norwalk | Connecticut |
| United States | Boehringer Ingelheim Investigational Site | Olathe | Kansas |
| United States | Boehringer Ingelheim Investigational Site | Palmdale | California |
| United States | Boehringer Ingelheim Investigational Site | Panama City | Florida |
| United States | Boehringer Ingelheim Investigational Site | River Forest | Illinois |
| United States | LSU MC-Sheveport | Shreveport | Louisiana |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | University of Texas Health Center at Tyler | Tyler | Texas |
| United States | Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado |
| United States | Wake Forest University, Center for Human Genomics | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1 | |||
| Secondary | FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs |
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