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

NCT ID: NCT02150499

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

levalbuterol tartrate HFA inhalation aerosol

Intervention Type: DRUG

placebo

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

levalbuterol tartrate HFA inhalation aerosol

Intervention Type: DRUG

Interventions

levalbuterol tartrate HFA inhalation aerosol

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Xopenex HFA® (Levalbuterol tartrate) Inhalation Aerosol

Eligibility Criteria

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.

• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Respiratory Medical Director, MD

Role: STUDY_DIRECTOR

Sumitomo Pharma America, Inc.

Locations

Score Physician Alliance, LLC

St. Petersburg, Florida, United States

Northern Illinios Research Associates

DeKalb, Illinois, United States

Northern Illinois Associates

DeKalb, Illinois, United States

Michael W. Simon, MD, PSC

Nicholasville, Kentucky, United States

Willis-Knighton Physician Network / Portico Pediatrics

Shreveport, Louisiana, United States

Mid Michigan Sleep Center

Grand Blanc, Michigan, United States

Craig Spiegel, MD

Bridgeton, Missouri, United States

St. Peter's University Hospital

New Brunswick, New Jersey, United States

Capital Pediatrics & Adolescent Center PLLC

Raleigh, North Carolina, United States

Capitol Pediatric & Adolescent Center PLLC

Raleigh, North Carolina, United States

Dayton Clinical Research

Dayton, Ohio, United States

Charleston Allergy & Asthma Research

Summerville, South Carolina, United States

Holston Medical Group

Kingsport, Tennessee, United States

TTS Research

Boerne, Texas, United States

Allergy Asthma Research Institute

Waco, Texas, United States

PI-Coor Clinical Research

Burke, Virginia, United States

Advanced Pediatrics

Vienna, Virginia, United States

Countries

United States

Other Identifiers

SEP051-361

Identifier Type: -

Identifier Source: org_study_id