Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00096616

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Combivent® CFC MDI Drug: Albuterol HFA MDI	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Combivent Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1

Secondary Outcome Measures:

FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs

Estimated Enrollment:	108
Study Start Date:	November 2004
Estimated Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096616

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Locations

United States, Alabama
Cooper Green Hospital
Birmingham, Alabama, United States
620 South 20th Street, NHB 104
Birmingham, Alabama, United States
United States, California
Southern California Clinical Trials
Lakewood, California, United States
Boehringer Ingelheim Investigational Site
Palmdale, California, United States
United States, Colorado
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States
United States, Florida
Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
United States, Idaho
Boehringer Ingelheim Investigational Site
Coeur d'Arlene, Idaho, United States
United States, Illinois
Boehringer Ingelheim Investigational Site
River Forest, Illinois, United States
United States, Kansas
Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
United States, Louisiana
LSU MC-Sheveport
Shreveport, Louisiana, United States
United States, Maine
Boehringer Ingelheim Investigational Site
Auburn, Maine, United States
United States, Maryland
Johns Hopkins Asthma & Allergy
Baltimore, Maryland, United States
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States
United States, New Jersey
Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey, United States
Boehringer Ingelheim Investigational Site
Berlin, New Jersey, United States
United States, New York
North Shore University Hospital
Manhasset, New York, United States
NYU School of Medicine
New York, New York, United States
United States, North Carolina
Wake Forest University, Center for Human Genomics
Winston-Salem, North Carolina, United States
Division of Pulmonary & Critical Care Medicine
Durham, North Carolina, United States
United States, Pennsylvania
Penn State University, Hershey Medical Center
Hershey, Pennsylvania, United States
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
United States, Texas
Ben Taul General Hospital
Houston, Texas, United States
University of Texas Health Center at Tyler
Tyler, Texas, United States
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Mar 5.

Study ID Numbers:	1012.50
Study First Received:	November 12, 2004
Last Updated:	September 27, 2009
ClinicalTrials.gov Identifier:	NCT00096616 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tocolytic Agents

Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009