Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma

February 21, 2012 updated by: Sunovion

A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatric Subjects With Asthma

The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-blind, active-controlled multicenter, two-way crossover study of HFA levalbuterol (with and without a spacer) in subjects 4-11 years of age with asthma. 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)

31

Phase

  • Phase 2

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

  • United States
    • California
      • Madera, California, United States
      • San Diego, California, United States
    • Georgia
      • Savannah, Georgia, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • New York
      • Cortland, New York, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Chester, Pennsylvania, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, 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

4 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject, male or female, must be between the ages of 4 to 11 years, inclusive, at the time of consent.
  • Female subjects who are 8 years of age or older will have a negative serum pregnancy test at study start.
  • 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 or have one taken within 12 months prior to randomization may be used.
  • 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 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 prior to study start, or who is currently participating in another clinical trial.
  • Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM.
  • 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.
  • 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 2 weeks prior to study start.
  • Subject 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 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A

Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (8 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (8 cumulative doses).

The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects.
Drug: Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI
(a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)
Other Names:
  • Xopenex HFA MDI
  • albuterol HFA MDI
ACTIVE_COMPARATOR: B
Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses) The first treatment will be administered, followed by a 7 ±2 days washout period, after which the second of the two treatments will be administered. Cumulative dosing will occur according to the following schedule: 1 puff at 0 and 30 minutes, 2 puffs at 60 minutes, 4 puffs at 90 minutes and 8 puffs at 120 minutes. Treatment will be administered with an AeroChamber Plus ™ spacer for the first cohort (spacer cohort) of subjects and without the AeroChamber Plus ™ spacer (non-spacer cohort) for the second cohort of subjects.
Drug: Racemic Albuterol followed by levalbuterol HFA MDI
(a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)
Other Names:
  • Xopenex HFA MDI
  • albuterol HFA MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic), potassium and glucose
Time Frame: 0, 7, 10 days
0, 7, 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in FEV1 (from visit pre-dose to each post dose measure)
Time Frame: Days 0, 7, 10
Days 0, 7, 10
Number of cumulative actuations received
Time Frame: Days 0, 7, 10
Days 0, 7, 10
Percent change in FVC (from visit pre-dose to each post dose measure)
Time Frame: Days 0, 7, 10
Days 0, 7, 10
Percent change in FEF25-75% (from visit pre-dose to each post dose measure)
Time Frame: Days 0, 7, 10
Days 0, 7, 10

Collaborators and Investigators

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

Sponsor

Sunovion

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

January 1, 2003

Primary Completion (ACTUAL)

July 1, 2003

Study Completion (ACTUAL)

July 1, 2003

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (ESTIMATE)

May 28, 2008

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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051-311

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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