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

Tracking Information

First Received Date ^ICMJE

November 12, 2004

Last Updated Date

September 27, 2009

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00096616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Combivent® CFC MDI
Drug: Albuterol HFA MDI

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

108

Completion Date

August 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00096616

Responsible Party

Study ID Numbers ^ICMJE

1012.50

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP