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

Information source: Sunovion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exercise-induced Bronchospasm

Intervention: Levalbuterol tartrate HFA MDI (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sunovion

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: maximum percent FEV1 decrease from visit postdose/prechallenge

Secondary outcome:

FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)

time to FEV1 recovery

minimum percent change in FEV1 from visit postdose/prechallenge

minimum percent change in FEV1 from visit predose

protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)

percent change in FEV1 from predose to postdose/prechallenge

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Denver, Colorado, United States

Burke, Virginia, United States

Additional Information

Starting date: December 2005
Last updated: February 21, 2012

Page last updated: August 23, 2015

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