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

This study has been completed.

First Received: November 12, 2004 Last Updated: September 27, 2009 History of Changes

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

Show 27 Study Locations

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