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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00096616
First received: November 12, 2004
Last updated: October 31, 2013
Last verified: October 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


Further study details as provided by Boehringer Ingelheim:

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

Enrollment: 113
Study Start Date: November 2004
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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
University of Miami School of Medicine
Miami, Florida, United States
Boehringer Ingelheim Investigational Site
Panama City, 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
Berlin, New Jersey, United States
Boehringer Ingelheim Investigational Site
Cherry Hill, 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
Division of Pulmonary & Critical Care Medicine
Durham, North Carolina, United States
Wake Forest University, Center for Human Genomics
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Penn State University, Hershey Medical Center
Hershey, Pennsylvania, United States
United States, South Carolina
Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
Spartanburg Medical Research
Spartanburg, 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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00096616     History of Changes
Other Study ID Numbers: 1012.50
Study First Received: November 12, 2004
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014