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| Sponsor: | Sunovion |
|---|---|
| Information provided by: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00268723 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Exercise-Induced Bronchospasm |
Drug: Levalbuterol tartrate HFA MDI Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 15 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
levalbuterol HFA MDI 90 mcg QID
|
Drug: Levalbuterol tartrate HFA MDI
levalbuterol MDI 90 mcg QID
Other Name: Xopenex MDI
|
|
Placebo Comparator: 2
Placebo MDI QID
|
Drug: Placebo
Placebo MDI QID
|
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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
More Information
| Responsible Party: | Xopenex Medical Affairs Director, Sunovion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00268723 History of Changes |
| Other Study ID Numbers: | 051-925 |
| Study First Received: | December 20, 2005 |
| Last Updated: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Bronchial Spasm Asthma, Exercise-Induced Bronchial Diseases Respiratory Tract Diseases Asthma Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |