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

February 21, 2012 updated by: Sunovion

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States
    • Virginia
      • Burke, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
levalbuterol HFA MDI 90 mcg QID
levalbuterol MDI 90 mcg QID
Other Names:
  • Xopenex MDI
Placebo Comparator: 2
Placebo MDI QID
Placebo MDI QID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum percent FEV1 decrease from visit postdose/prechallenge
Time Frame: Days 1, 4, 7
Days 1, 4, 7

Secondary Outcome Measures

Outcome Measure
Time Frame
FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)
Time Frame: Days 1, 4, 7
Days 1, 4, 7
time to FEV1 recovery
Time Frame: Days 1, 4, 7
Days 1, 4, 7
minimum percent change in FEV1 from visit postdose/prechallenge
Time Frame: Days 1, 4, 7
Days 1, 4, 7
minimum percent change in FEV1 from visit predose
Time Frame: Days 1, 4, 7
Days 1, 4, 7
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
Days 1, 4, 7
percent change in FEV1 from predose to postdose/prechallenge
Time Frame: Days 1, 4, 7
Days 1, 4, 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

December 20, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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