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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685347
• Other study ID #: 051-312
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2008
• Last updated: February 21, 2012
• Start date: January 2003
• Est. completion date: June 2003

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchoconstriction

Intervention

Drug:
• Levalbuterol HFA MDI
levalbuterol 45 µg (1 actuation of 45 µg); (b) levalbuterol 90 µg (2 actuation of 45 µg) and (c) levalbuterol 180 µg (4 actuations of 45 µg each). Arm #A Xopenex HFA MDI
• Racemic Albuterol
racemic albuterol 90 µg (1 actuation of 90 µg); (b) racemic albuterol 180 µg (2 actuations of 90 µg) and (c) racemic albuterol 360 µg (4 actuations of 90 µg). Arm #B Proventil HFA MDI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum percent decrease in FEV1 from visit post-dose/pre-challenge FEV1		Days -7, 0, 5, 10, 15	No
Secondary	Area under the percent decrease from visit post-dose/pre-challenge FEV1 curve		Days -7, 0, 5, 10, 15	No
Secondary	Area under the percent decrease from visit pre-dose FEV1 curve.		Days -7, 0, 5, 10, 15	No
Secondary	Minimum percent change in FEV1 from visit pre-dose FEV1.		Days -7, 0, 5, 10, 15	No
Secondary	Minimum percent change in FEV1 from visit post dose/pre-challenge FEV1		Days -7, 0, 5, 10, 15	No
Secondary	percent change in FEV1 from visit predose to the post-dose/pre-challenge FEV1		Days -7, 0, 5, 10, 15	No
Secondary	Time to recovery (min), Protected/Unprotected Subjects Counts		Days -7, 0, 5, 10, 15	No
Secondary	Area under the percent decrease from visit post-dose/pre-challenge FVC,		Days -7, 0, 5, 10, 15	No
Secondary	Maximum percent decrease in FVC from visit post-dose/pre-challenge FVC		Days -7, 0, 5, 10, 15	No
Secondary	Minimum percent change in FVC from pre-dose FVC		Days -7, 0, 5, 10, 15	No
Secondary	Area under the percent decrease from visit post-dose/pre-challenge FEF25%-75% curve		Days -7, 0, 5, 10, 15	No
Secondary	Maximum percent decrease in FEF25-75% from visit post-dose/pre-challenge FEF25-75%		Days -7, 0, 5, 10, 15	No
Secondary	Minimum percent change in FEF25%-75% from visit pre-dose FEF25-75%.		Days -7, 0, 5, 10, 15	No