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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

Tracking Information
First Submitted Date  ICMJE November 12, 2004
First Posted Date  ICMJE November 15, 2004
Last Update Posted Date November 1, 2013
Study Start Date  ICMJE November 2004
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2005)
  • FEV1 area under the curve (AUC) 0 to 6 hours
  • Peak FEV1
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2005)
  • FEV1 at each timepoint
  • Peak FVC
  • FVC at each timepoint
  • FVC AUC 0-6
  • Adverse events
  • Vital signs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Combivent® CFC MDI
  • Drug: Albuterol HFA MDI
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
113
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00096616
Other Study ID Numbers  ICMJE 1012.50
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP