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

• ClinicalTrials.gov Identifier: NCT00096616
• Recruitment Status: Completed
• First Posted: November 15, 2004
• Last Update Posted: November 1, 2013
• Sponsor: Boehringer Ingelheim
• Information provided by: Boehringer Ingelheim

Tracking Information

• First Submitted Date: November 12, 2004
• First Posted Date: November 15, 2004
• Last Update Posted Date: November 1, 2013
• Study Start Date: November 2004
• Actual Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 7, 2005): FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1

Original Primary Outcome Measures (submitted: June 27, 2005)

• FEV1 area under the curve (AUC) 0 to 6 hours
• Peak FEV1

• Current Secondary Outcome Measures (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 (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: Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Asthma

Intervention

• Drug: Combivent® CFC MDI
• Drug: Albuterol HFA MDI

• Study Arms: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 31, 2013): 113
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00096616
• Other Study ID Numbers: 1012.50
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Boehringer Ingelheim
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim Study Coordinator; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: October 2013