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
1 other identifier
interventional
18
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Jul 2014
Shorter than P25 for phase_3 asthma
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
February 3, 2016
CompletedApril 8, 2016
March 1, 2016
5 months
May 27, 2014
November 18, 2015
March 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
Change From Baseline in Pulmonary Score (Total Score) to End of Treatment
Day 1
Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment
Day 1
Change From Baseline in Pulmonary Score (Total Score) After Each Dose
20 minutes, 40 minutes, 60 minutes
Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose
20 minutes, 40 minutes, 60 minutes
Number and Percentage of Subjects Determined to be Stabilized After Treatment
Day 1
Study Arms (2)
levalbuterol tartrate HFA inhalation aerosol plus placebo HFA
EXPERIMENTALThree 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
levalbuterol tartrate HFA inhalation aerosol plus levalbuterol
EXPERIMENTALThree 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- Subject experiencing acute bronchospasm requiring a bronchodilator and who have a history of wheezing.
You may not qualify if:
- Subject with a severe illness that, in the opinion of the Investigator, could jeopardize subject safety.
- 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.
- Subject received ipratropium within 4 hours prior to ED or physician's office admittance.
- Subject who participated in an investigational drug study within 30 days prior to enrollment, or who previously participated in the current study.
- 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 (including beta-blockers) with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
- 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).
- Subject with a history of cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Score Physician Alliance, LLC
St. Petersburg, Florida, 33710, United States
Northern Illinios Research Associates
DeKalb, Illinois, 60115, United States
Northern Illinois Associates
DeKalb, Illinois, 60115, United States
Michael W. Simon, MD, PSC
Nicholasville, Kentucky, 40356, United States
Willis-Knighton Physician Network / Portico Pediatrics
Shreveport, Louisiana, 71105, United States
Mid Michigan Sleep Center
Grand Blanc, Michigan, 48439, United States
Craig Spiegel, MD
Bridgeton, Missouri, 63044, United States
St. Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Capital Pediatrics & Adolescent Center PLLC
Raleigh, North Carolina, 27609, United States
Capitol Pediatric & Adolescent Center PLLC
Raleigh, North Carolina, 27609, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Charleston Allergy & Asthma Research
Summerville, South Carolina, 29485, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
TTS Research
Boerne, Texas, 78006, United States
Allergy Asthma Research Institute
Waco, Texas, 76712, United States
PI-Coor Clinical Research
Burke, Virginia, 22015, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Respiratory Medical Director
- Organization
- Sunovion Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Respiratory Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2014
First Posted
May 30, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 8, 2016
Results First Posted
February 3, 2016
Record last verified: 2016-03