Clinical trial NCT02150499: A Study of Levalbuterol Tartrate HFA Inhalation Aerosol Metered Dose Inhaler (MDI) in Pediatric Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma
Keywords: Acute Asthma exacerbation
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 18
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.
timeFrame: Week 1
measure: The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.
timeFrame: Week 1
measure: 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.
timeFrame: Week 1
Secondary outcomes:
measure: Change From Baseline in Pulmonary Score (Total Score) to End of Treatment
timeFrame: Day 1
measure: Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment
timeFrame: Day 1
measure: Change From Baseline in Pulmonary Score (Total Score) After Each Dose
timeFrame: 20 minutes, 40 minutes, 60 minutes
measure: Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose
timeFrame: 20 minutes, 40 minutes, 60 minutes
measure: Number and Percentage of Subjects Determined to be Stabilized After Treatment
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Score Physician Alliance, LLC
state: Florida
city: Dekalb
country: United States
facility: Northern Illinios Research Associates
state: Illinois
city: Dekalb
country: United States
facility: Northern Illinois Associates
state: Illinois
city: Nicholasville
country: United States
facility: Michael W. Simon, MD, PSC
state: Kentucky
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network / Portico Pediatrics
state: Louisiana
city: Grand Blanc
country: United States
facility: Mid Michigan Sleep Center
state: Michigan
city: Bridgeton
country: United States
facility: Craig Spiegel, MD
state: Missouri
city: New Brunswick
country: United States
facility: St. Peter's University Hospital
state: New Jersey
city: Raleigh
country: United States
facility: Capital Pediatrics & Adolescent Center PLLC
state: North Carolina
city: Raleigh
country: United States
facility: Capitol Pediatric & Adolescent Center PLLC
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Summerville
country: United States
facility: Charleston Allergy & Asthma Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Burke
country: United States
facility: PI-Coor Clinical Research
state: Virginia
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Respiratory Medical Director, MD
role: STUDY_DIRECTOR
References: