A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects

A Safety and Tolerability Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects Birth to ≤ 48 Months of Age With Reactive Airways Disease in an Acute Setting

This is a study of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who go to the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: placebo; Drug: levalbuterol tartrate HFA inhalation aerosol

Detailed Description

This is a study to determine the safety and tolerability of cumulative dosing with levalbuterol tartrate HFA inhalation aerosol MDI using a valved holding chamber and facemask in pediatric subjects birth to ≤ 48 months of age with acute bronchospasm. It is a randomized, double-blind, parallel-group, multicenter, trial of 3 doses of levalbuterol tartrate HFA inhalation aerosol MDI in pediatric subjects birth to ≤ 48 months of age who present to either the Emergency Department (ED) or their physician's office with an acute bronchospasm. Subjects presenting to the ED or physician's office with an acute bronchospasm must have a history of reactive airways disease, based on subjects' parent/guardian report.

Eligible subjects whose parent(s) or legal guardian(s) provide written informed consent to participate will be randomized to 1 of 2 treatments. Treatment 1 consists of 3 doses, with each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA [cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol]); Treatment 2 consists of 3 doses, with each dose comprised of 8 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff [cumulative dose of 1080 mcg of levalbuterol tartrate HFA inhalation aerosol]). For each Treatment, study medication will be administered every 20 minutes over a period of 1 hour for three doses.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance, LLC
  • Illinois
    • Dekalb, Illinois, United States, 60115
      • Northern Illinios Research Associates
    • Dekalb, Illinois, United States, 60115
      • Northern Illinois Associates
  • Kentucky
    • Nicholasville, Kentucky, United States, 40356
      • Michael W. Simon, MD, PSC
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Willis-Knighton Physician Network / Portico Pediatrics
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Mid Michigan Sleep Center
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Craig Spiegel, MD
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • St. Peter's University Hospital
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Capital Pediatrics & Adolescent Center PLLC
    • Raleigh, North Carolina, United States, 27609
      • Capitol Pediatric & Adolescent Center PLLC
  • Ohio
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Charleston Allergy & Asthma Research
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Boerne, Texas, United States, 78006
      • TTS Research
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
  • Virginia
    • Burke, Virginia, United States, 22015
      • PI-Coor Clinical Research
    • Vienna, Virginia, United States, 22180
      • Advanced Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female from birth to 48 months of age, inclusive, whose parent(s) or legal guardian(s) provide written informed consent prior to study participation and are willing to comply with study procedures.
2. Subject experiencing acute bronchospasm requiring a bronchodilator and who have a history of wheezing.

Exclusion Criteria:

1. Subject with a severe illness that, in the opinion of the Investigator, could jeopardize subject safety.
2. Subject received ≥ 8 puffs (MDI) of a beta-2 agonist or 2.5 mg of nebulized levalbuterol, or albuterol 5.0 mg within 4 hours prior to ED or physician's office admittance.
3. Subject received ipratropium within 4 hours prior to ED or physician's office admittance.
4. Subject who participated in an investigational drug study within 30 days prior to enrollment, or who previously participated in the current study.
5. Subject with a known sensitivity to levalbuterol or racemic albuterol or any of the excipients contained in any of these formulations.
6. Subject using any prescription drug (including beta-blockers) with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
7. Subject with a history of clinically significant abnormalities that could interfere with the metabolism or excretion of the study medication (eg, renal, hepatic, metabolic, or endocrine abnormalities).
8. Subject with a history of cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: levalbuterol tartrate HFA inhalation aerosol plus placebo HFA; Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol	Drug: placebo; Drug: levalbuterol tartrate HFA inhalation aerosol; Other Names: Xopenex HFA® (Levalbuterol tartrate) Inhalation Aerosol
Experimental: levalbuterol tartrate HFA inhalation aerosol plus levalbuterol; Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.	Drug: levalbuterol tartrate HFA inhalation aerosol; Other Names: Xopenex HFA® (Levalbuterol tartrate) Inhalation Aerosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	Week 1
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	Week 1
The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation.	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Pulmonary Score (Total Score) to End of Treatment	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	Day 1
Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	Day 1
Change From Baseline in Pulmonary Score (Total Score) After Each Dose	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	20 minutes, 40 minutes, 60 minutes
Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	20 minutes, 40 minutes, 60 minutes
Number and Percentage of Subjects Determined to be Stabilized After Treatment	Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.	Day 1

Collaborators and Investigators

• Sponsor: Sunovion

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Acute Asthma exacerbation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: SEP051-361