A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma

NCT ID: NCT00809757

Last Updated: 2014-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-06-30

Brief Summary

A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.

Detailed Description

This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to <48 months with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

Asthma

Study Design

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

Study Groups

1

90 ug Levalbuterol (2 actuations)

Group Type: EXPERIMENTAL

Levalbuterol

Intervention Type: DRUG

90 ug Levalbuterol (2 actuations)

2

0.31 ug Levalbuterol UDV TID

Group Type: ACTIVE_COMPARATOR

Levalbuterol UDV TID

Intervention Type: DRUG

0.31 ug Levalbuterol UDV TID

3

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (2 actuations)

Interventions

Levalbuterol

90 ug Levalbuterol (2 actuations)

Intervention Type: DRUG

Levalbuterol UDV TID

0.31 ug Levalbuterol UDV TID

Intervention Type: DRUG

Placebo

Placebo (2 actuations)

Intervention Type: DRUG

Other Intervention Names

Xopenex HFA Inhalation Aerosol; Xopenex Inhalation Solution

Eligibility Criteria

Inclusion Criteria

• Subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. Complete documentation regarding the consent process must be recorded in the case report form (CRF) and source documentation.
• Subject's parent/legal guardian must be willing and able to comply with the study procedures and visit schedules.
• Subject, male or female, must be between the ages of birth and <48 months, exclusive, at the time of consent.
• Subjects 24 to <48 months of age must have a history of physician-diagnosed asthma (defined as at least 3 episodes of respiratory symptoms consistent with asthma symptoms including, but not limited to, cough, wheeze, or dyspnea).
• Subjects 0 to <24 months of age must have a history of 3 episodes of respiratory symptoms that in the judgement of the investigator could be consistent with asthma or reactive airways disease.
• Subject must be in good health and not affected by any other chronic conditions, including respiratory disorders other than asthma.
• In subjects with a chest radiograph (taken 12 months prior to screening visit), no evidence of any chronic cardiopulmonary condition other than asthma should be present as discerned by the Investigator.
• Subject's parent/legal guardian must be able to complete the diary cards and medical event calendars (MEC) reliably on a daily basis and understand dosing instructions and questionnaire completion.

Exclusion Criteria

• Subject who requires or is expected to require any disallowed medications
• Subject who has participated in an investigational drug study within 30 days prior to screening, or who is currently participating in another clinical trial.
• Subject or parent/legal guardian who has daily commitments during the study that would interfere with trial measurements, compliance, or both.
• Subject who has a history of hospitalization for asthma, reactive airways disease, or bronchospasm within 4 weeks prior to screening or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial.
• Subject who has experienced significant blood loss within 60 days of study drug.
• Subject with a clinical diagnosis of cystic fibrosis.
• Subject who was born prematurely, defined as less than 38 weeks gestational age at birth, and is <1 year of age at screening
• Subject whose body weight is less than 7.0 kg at screening. This minimum weight requirement is based upon standard pediatric growth charts [CDC 2000].
• 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 with which levalbuterol or racemic albuterol sulfate administration is contraindicated.
• Subject with a history of life-threatening asthma, defined as previous asthma episodes requiring intubation or associated with hypercapnia, respiratory arrest, or hypoxic seizures.
• Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drugs or study participation (eg, abnormalities of renal, hepatic, metabolic, or endocrine function).
• Subject with a history of cancer.
• Subject with any chronic or congenital cardiorespiratory condition other than asthma including, but not limited to, bronchopulmonary dysplasia, congenital heart disease, and cystic fibrosis.
• Subject affected by an upper or lower respiratory tract infection in the 3 weeks prior to screening.
• Subject with a history of ventilation for a respiratory condition occurring at or near birth, including those associated with prematurity or bronchopulmonary dysplasia. Ventilatory support for elective non-cardiopulmonary surgery is not exclusionary. - Subject with any clinically significant abnormal laboratory values (hematology, blood chemistry).
• Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects.
• Subject who is a relative of a staff member.

• 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

Little Rock Allergy & Asthma Clinical Research Center

Little Rock, Arkansas, United States

West Coast Clinical Trials, LLC

Cypress, California, United States

Allergy & Asthma Care Center of Southern California

Long Beach, California, United States

Clinical Trials of Orange County, Inc.

Orange, California, United States

Allergy and Asthma Consultants

Redwood City, California, United States

IMMUNOe International Research Centers

Centennial, Colorado, United States

All Seasons Allergy and Asthma Center, P.A.

Fort Walton Beach, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Brookstone Centre Parkway

Columbus, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Northern Illinois Research Associates

DeKalb, Illinois, United States

Sneeze, Wheeze & Itch Associates LLC

Normal, Illinois, United States

Nassim, McMonigle, Mescia & Associates

New Albany, Indiana, United States

Grand Blanc Medical

Grand Blanc, Michigan, United States

Craig A. Spiegel MD

Bridgeton, Missouri, United States

Midwest Allergy and Asthma center

Omaha, Nebraska, United States

The Asthma & Allergy Center, P.C.

Papillion, Nebraska, United States

Maimonides Medical Center

Brooklyn, New York, United States

St. Elizabeth Health Center

Utica, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Dayton Clinical Research

Dayton, Ohio, United States

Allergy, Asthma and clinical Research Center

Oklahoma City, Oklahoma, United States

Eminence Research, LLC

Oklahoma City, Oklahoma, United States

Asthma and Allergy Research Associates

Upland, Pennsylvania, United States

National Allergy, Asthma, and Uticaria Centers

Charleston, South Carolina, United States

AAC Research - PC

Charleston, South Carolina, United States

ADAC Research, PA

Greenville, South Carolina, United States

The Asthma Institute, PLLC

Chattanooga, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Isis Clinical Research, LLC

Austin, Texas, United States

Sirius Clinical Research, LLC

Austin, Texas, United States

Hill Country Family Medical Center

Boerne, Texas, United States

TTS Research

Boerne, Texas, United States

Allergy/Immunology Research Center of North Texas

Dallas, Texas, United States

Dallas Allergy Immunology Research

Dallas, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Breath of Life Research Institute

Katy, Texas, United States

Live Oak Allergy and Asthma Clinic

Live Oak, Texas, United States

Quality Assurance Research Center, Inc.

San Antonio, Texas, United States

Southwest Allergy and Asthma, P.A.

San Antonio, Texas, United States

Sylvana Research Associates

San Antonio, Texas, United States

Allergy & Asthma Care of Waco

Waco, Texas, United States

Allergy and Asthma Research Institute

Waco, Texas, United States

PI-Coor Clinical Research, LLC

Burke, Virginia, United States

Colonial Heights Pediatrics

Colonial Heights, Virginia, United States

Bellingham Asthma, Allergy, & Immunology Clinic

Bellingham, Washington, United States

Countries

United States

Other Identifiers

051-359

Identifier Type: -

Identifier Source: org_study_id