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Tracking Information | |
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First Received Date † | December 20, 2005 |
Last Updated Date | June 6, 2008 |
Start Date † | December 2005 |
Current Primary Outcome Measures † |
maximum percent FEV1 decrease from visit postdose/prechallenge [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00268723 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB |
Official Title † | An Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Versus Placebo in Prevention of EIB in Subjects 18 Years of Age and Older With EIB |
Brief Summary | To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated. |
Detailed Description | This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB. |
Study Phase | Phase III |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
Condition † | Exercise-Induced Bronchospasm |
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Enrollment † | 15 |
Completion Date | February 2006 |
Primary Completion Date | February 2006 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria
Exclusion Criteria
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00268723 |
Responsible Party | Xopenex Medical Affairs Director, Sepracor Inc. |
Secondary IDs †† | |
Study Sponsor † | Sepracor, Inc. |
Collaborators †† | |
Investigators † | |
Information Provided By | Sepracor, Inc. |
Verification Date | June 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |