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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096616
Recruitment Status : Completed
First Posted : November 15, 2004
Last Update Posted : November 1, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Combivent® CFC MDI Drug: Albuterol HFA MDI Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : November 2004
Actual Primary Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1

Secondary Outcome Measures :
  1. FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096616


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00096616    
Other Study ID Numbers: 1012.50
First Posted: November 15, 2004    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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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
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action