Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects

Condition(s) targeted: Asthma; Bronchoconstriction

Intervention: Levalbuterol HFA MDI (Drug); Racemic Albuterol (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Sepracor, Inc.

The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma

Official title: A Dose Response Study of Levalbuterol and Racemic Albuterol HFA MDI in Pediatric Subjects With Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1

Secondary outcome:

Area under the percent decrease from visit post-dose/pre-challenge FEV1 curve

Area under the percent decrease from visit pre-dose FEV1 curve.

Minimum percent change in FEV1 from visit pre-dose FEV1.

Minimum percent change in FEV1 from visit post dose/pre-challenge FEV1

percent change in FEV1 from visit predose to the post-dose/pre-challenge FEV1

Time to recovery (min), Protected/Unprotected Subjects Counts

Area under the percent decrease from visit post-dose/pre-challenge FVC,

Maximum percent decrease in FVC from visit post-dose/pre-challenge FVC

Minimum percent change in FVC from pre-dose FVC

Area under the percent decrease from visit post-dose/pre-challenge FEF25%-75% curve

Maximum percent decrease in FEF25-75% from visit post-dose/pre-challenge FEF25-75%

Minimum percent change in FEF25%-75% from visit pre-dose FEF25-75%.

Detailed description: A randomized, double-blind, active controlled, multicenter, parallel treatment, 3x3 dose level crossover study evaluating the dose response of levalbuterol in pediatric subjects between the ages of 6 and 11, inclusive with exercise induced bronchoconstriction.

Minimum age: 6 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject, male or female, must be between the ages of 6 to 11 years, inclusive, at the

time of consent.

- Female subjects who are 8 years of age or older must have a negative serum pregnancy

test.

- Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to

study start

- Subject must be in good health with the exception of their reversible airways disease

and not suffering from any chronic condition that might affect their respiratory function.

- Subject must have a chest X-ray for the study or within 12 months prior to

randomization.

- Subject's parent/legal guardian must be able to complete the diary cards and medical

event calendars reliably on a daily basis and understand dosing instructions. Any minor subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.

Exclusion Criteria:

- Female subject who is pregnant or lactating.

- Subject who has participated in an investigational drug study within 30 days of study

start, or who is currently participating in another clinical trial.

- Subject whose schedule prevents him or her from starting study visits before 2: 30-4: 00

PM.

- Subject who is unwilling or physically unable to perform the exercise challenges as

described in the protocol.

- Subject who has travel commitments during the study that would interfere with trial

measurements or compliance or both.

- Subject who has a history of hospitalization for asthma within 4 weeks prior to study

start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.

- Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the

excipients contained in any of these formulations.

- Subject using any prescription drug with which albuterol sulfate administration is

contraindicated.

- Subject with currently diagnosed life-threatening asthma defined as a history of

asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior to study start.

- Subject with a history of cancer (exception: basal cell carcinoma in remission).

- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure

disorders.

- Subject with a history of substance abuse or drug abuse within 12 months preceding

study start.

- Subject with a history of cigarette smoking or use of any tobacco products.

- Subject with a documented history of bronchopulmonary aspergillosis or any form of

allergic alveolitis.

- Subject who has suffered from a clinically significant upper or lower respiratory

tract infection in the 3 weeks prior to study start.

- Subjects with unstable asthma; or who have had a change in asthma therapy; or a visit

to the Emergency Department or hospital for worsening asthma within 4 weeks.

- Subject who is a staff member or relative of a staff member.

Long Beach, California, United States

Englewood, Colorado, United States

Denver, Colorado, United States

Dartmouth, Massachusetts, United States

Dallas, Texas, United States

Burke, Virginia, United States

Starting date: January 2003
Ending date: June 2003
Last updated: June 19, 2008