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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
ClinicalTrials.gov Identifier:
NCT00096616
First received: November 12, 2004
Last updated: October 31, 2013
Last verified: October 2013

November 12, 2004
October 31, 2013
November 2004
March 2006   (final data collection date for primary outcome measure)
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
  • FEV1 area under the curve (AUC) 0 to 6 hours
  • Peak FEV1
Complete list of historical versions of study NCT00096616 on ClinicalTrials.gov Archive Site
FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
  • FEV1 at each timepoint
  • Peak FVC
  • FVC at each timepoint
  • FVC AUC 0-6
  • Adverse events
  • Vital signs
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
  • Drug: Combivent® CFC MDI
  • Drug: Albuterol HFA MDI
Not Provided
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. Epub 2008 Mar 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
Not Provided
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00096616
1012.50
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Boehringer Ingelheim
October 2013

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