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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combivent® CFC MDI
Albuterol HFA MDI
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 620 South 20th Street, NHB 104
  • Cooper Green Hospital
  • Southern California Clinical Trials
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Norwalk Hospital
  • University of Miami School of Medicine
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • LSU MC-Sheveport
  • Boehringer Ingelheim Investigational Site
  • Johns Hopkins Asthma & Allergy
  • Brigham & Women's Hospital
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • North Shore University Hospital
  • NYU School of Medicine
  • Division of Pulmonary & Critical Care Medicine
  • Wake Forest University, Center for Human Genomics
  • Penn State University, Hershey Medical Center
  • Boehringer Ingelheim Investigational Site
  • Spartanburg Medical Research
  • Ben Taul General Hospital
  • University of Texas Health Center at Tyler
  • University of Wisconsin Hospital

Outcomes

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

Full Information

First Posted
November 12, 2004
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00096616
Brief Title
Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Combivent® CFC MDI
Intervention Type
Drug
Intervention Name(s)
Albuterol HFA MDI
Primary Outcome Measure Information:
Title
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
Secondary Outcome Measure Information:
Title
FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
620 South 20th Street, NHB 104
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Cooper Green Hospital
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Southern California Clinical Trials
City
Lakewood
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Palmdale
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Panama City
State/Province
Florida
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Coeur d'Arlene
State/Province
Idaho
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
River Forest
State/Province
Illinois
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Olathe
State/Province
Kansas
Country
United States
Facility Name
LSU MC-Sheveport
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Auburn
State/Province
Maine
Country
United States
Facility Name
Johns Hopkins Asthma & Allergy
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
State/Province
New Jersey
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
Country
United States
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Division of Pulmonary & Critical Care Medicine
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Wake Forest University, Center for Human Genomics
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Penn State University, Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Ben Taul General Hospital
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
Country
United States
Facility Name
University of Wisconsin Hospital
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18403223
Citation
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1012/1012.50_U06-3585.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1012/1012.50_literature.pdf
Description
Related Info

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

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