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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Combivent® CFC MDI; Drug: Albuterol HFA MDI

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General 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. doi: 10.1016/j.pupt.2008.02.005. Epub 2008 Mar 5.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: November 12, 2004
• First Submitted That Met QC Criteria: November 12, 2004
• First Posted (Estimate): November 15, 2004

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: 1012.50