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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02150499
• Other study ID #: SEP051-361
• Status: Terminated
• Phase: Phase 3
• First received: May 27, 2014
• Last updated: January 4, 2016
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• levalbuterol tartrate HFA inhalation aerosol

• placebo

Locations

Country	Name	City	State
United States	TTS Research	Boerne	Texas
United States	Craig Spiegel, MD	Bridgeton	Missouri
United States	PI-Coor Clinical Research	Burke	Virginia
United States	Dayton Clinical Research	Dayton	Ohio
United States	Northern Illinios Research Associates	Dekalb	Illinois
United States	Northern Illinois Associates	Dekalb	Illinois
United States	Mid Michigan Sleep Center	Grand Blanc	Michigan
United States	Holston Medical Group	Kingsport	Tennessee
United States	St. Peter's University Hospital	New Brunswick	New Jersey
United States	Michael W. Simon, MD, PSC	Nicholasville	Kentucky
United States	Capital Pediatrics & Adolescent Center PLLC	Raleigh	North Carolina
United States	Capitol Pediatric & Adolescent Center PLLC	Raleigh	North Carolina
United States	Score Physician Alliance, LLC	Saint Petersburg	Florida
United States	Willis-Knighton Physician Network / Portico Pediatrics	Shreveport	Louisiana
United States	Charleston Allergy & Asthma Research	Summerville	South Carolina
United States	Advanced Pediatrics	Vienna	Virginia
United States	Allergy Asthma Research Institute	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number and Percentage 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	No
Primary	The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number and Percentage 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	No
Primary	The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number and Percentage 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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No