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Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB
This study has been completed.
First Received: December 20, 2005   Last Updated: June 6, 2008   History of Changes
Sponsored by: Sepracor, Inc.
Information provided by: Sepracor, Inc.
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

MedlinePlus related topics: Exercise and Physical Fitness
Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
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

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:
  • maximum percent FEV1 decrease from visit postdose/prechallenge [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge) [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ]
  • time to FEV1 recovery [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ]
  • minimum percent change in FEV1 from visit postdose/prechallenge [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ]
  • minimum percent change in FEV1 from visit predose [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ]
  • protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1) [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ]
  • percent change in FEV1 from predose to postdose/prechallenge [ Time Frame: Days 1, 4, 7 ] [ Designated as safety issue: No ]

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
1: Experimental
levalbuterol HFA MDI 90 mcg QID
Drug: Levalbuterol tartrate HFA MDI
levalbuterol MDI 90 mcg QID
2: Placebo Comparator
Placebo MDI QID
Drug: Placebo
Placebo MDI QID

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Subjects were males or females and 18 years of age or older at the time of consent.
  • Female subjects considered not of childbearing potential were either surgically sterile or greater than one-year postmenopausal, defined as a complete cessation of menstruation for at least one year.
  • Female subjects of child-bearing potential had a negative urine pregnancy test at screening.
  • Female subjects of child-bearing potential agreed to use an acceptable method of birth control throughout the study.
  • Subjects were in good health and were not suffering from any chronic condition that might affect their respiratory or cardiac function (including cardiac arrhythmias).
  • Subjects had a documented diagnosis of exercise-induced bronchospasm for a minimum of 6 months prior to study start.
  • Subjects had stable baseline asthma and had been using a beta2-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months prior to study start.

Exclusion Criteria

  • Subjects with currently diagnosed life-threatening asthma defined as a history of: asthma episodes requiring intubation, associated hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
  • Subjects with a history of hospitalization for asthma within 4 weeks prior to study start, or who were scheduled for in-patient hospitalization, including elective surgery, during the course of the trial.
  • Subjects with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
  • Subjects who suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
  • Subjects with any clinically significant unstable medical abnormality, chronic disease (other than asthma), or history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, renal, endocrine, or central nervous systems that was not currently well controlled by medication or that may have interfered with the successful completion of the protocol.
  • Subjects with a history of cancer (exception: basal-cell carcinoma in remission for a minimum of 5 years).
  • Subjects with a known sensitivity to levalbuterol, racemic albuterol, or any of the excipients contained in any of these formulations.
  • Subjects using any prescription drug with which levalbuterol tartrate administration is contraindicated.
  • Subjects with a history of substance abuse or drug abuse within 12 months preceding study start.
  • Subjects who participated in an investigational drug study within 30 days prior to study start, or who were currently participating in another clinical trial.
  • Subjects with a greater than 10-pack-year history of cigarette smoking or use of any tobacco products within 6 months of study start.
  • Subject was a staff member or relative of a staff member.
  • Subjects with unstable asthma, or had a change in asthma therapy, or a visit to the emergency department or hospital for worsening asthma within 4 weeks of study start.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268723

Locations
United States, Colorado
Denver, Colorado, United States
United States, Virginia
Burke, Virginia, United States
Sponsors and Collaborators
Sepracor, Inc.
  More Information

No publications provided

Responsible Party: Sepracor Inc. ( Xopenex Medical Affairs Director )
Study ID Numbers: 051-925
Study First Received: December 20, 2005
Last Updated: June 6, 2008
ClinicalTrials.gov Identifier: NCT00268723     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Spasm
Neurotransmitter Agents
Bronchial Spasm
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Albuterol
Asthma
Anti-Asthmatic Agents
Adrenergic Agonists
Asthma, Exercise-Induced
Hypersensitivity
Respiratory Tract Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Bronchial Spasm
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Adrenergic Agonists
Hypersensitivity
Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Asthma, Exercise-Induced
Autonomic Agents
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 06, 2009