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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00096616
First received: November 12, 2004
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  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:

MedlinePlus related topics: Asthma
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
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

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: May 18, 2012
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
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013