Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00268723
First received: December 20, 2005
Last updated: February 21, 2012
Last verified: February 2012
  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 3

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

Resource links provided by NLM:


Further study details as provided by Sunovion:

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
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

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. 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
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
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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
Sunovion
  More Information

No publications provided

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00268723     History of Changes
Other Study ID Numbers: 051-925
Study First Received: December 20, 2005
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014