Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma

NCT ID: NCT00096616

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Combivent® CFC MDI

Intervention Type DRUG

Albuterol HFA MDI

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

620 South 20th Street, NHB 104

Birmingham, Alabama, United States

Site Status

Cooper Green Hospital

Birmingham, Alabama, United States

Site Status

Southern California Clinical Trials

Lakewood, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Palmdale, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

University of Miami School of Medicine

Miami, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Coeur d'Arlene, Idaho, United States

Site Status

Boehringer Ingelheim Investigational Site

River Forest, Illinois, United States

Site Status

Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

Site Status

LSU MC-Sheveport

Shreveport, Louisiana, United States

Site Status

Boehringer Ingelheim Investigational Site

Auburn, Maine, United States

Site Status

Johns Hopkins Asthma & Allergy

Baltimore, Maryland, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Boehringer Ingelheim Investigational Site

Berlin, New Jersey, United States

Site Status

Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

NYU School of Medicine

New York, New York, United States

Site Status

Division of Pulmonary & Critical Care Medicine

Durham, North Carolina, United States

Site Status

Wake Forest University, Center for Human Genomics

Winston-Salem, North Carolina, United States

Site Status

Penn State University, Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Ben Taul General Hospital

Houston, Texas, United States

Site Status

University of Texas Health Center at Tyler

Tyler, Texas, United States

Site Status

University of Wisconsin Hospital

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 18403223 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1012.50

Identifier Type: -

Identifier Source: org_study_id