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

NCT00809757 | Completed Phase 3 Results

• 1 other identifier: 051-359
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 46

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)

  The daily composite score is the sum of the scores of 5 domains: Nocturnal Awakenings Due to Wheeze and Cough, Daytime Wheeze, Daytime Cough, Shortness of Breath, and Asthma Symptom Score. A possible score of 0 (no symptoms) to 19 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean of the daily composite scores in the week prior to Visit 4.

  Baseline, Visit 4 (Week 4)

Secondary Outcomes (25)

• Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

  Baseline, Visit 3 (Week 3)

• Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

  The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days

• Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment

  The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days

• Change From Baseline to Visit 3 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by the Pediatric Asthma Questionnaire (PAQ)

  Baseline, Visit 3 (Week 3)

• Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Scores as Measured by Pediatric Asthma Questionnaire

  Baseline, Visit 4 (Week 4)

Study Arms (3)

1

EXPERIMENTAL

90 ug Levalbuterol (2 actuations)

Drug: Levalbuterol

2

ACTIVE COMPARATOR

0.31 ug Levalbuterol UDV TID

Drug: Levalbuterol UDV TID

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Levalbuterol DRUG

90 ug Levalbuterol (2 actuations)

Also known as: Xopenex HFA Inhalation Aerosol

1

Levalbuterol UDV TID DRUG

0.31 ug Levalbuterol UDV TID

Also known as: Xopenex Inhalation Solution

2

Placebo DRUG

Placebo (2 actuations)

3

Eligibility Criteria

• Age: Up to 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (46)

Little Rock Allergy & Asthma Clinical Research Center

Little Rock, Arkansas, 72205, United States

Location

West Coast Clinical Trials, LLC

Cypress, California, 90630, United States

Location

Allergy & Asthma Care Center of Southern California

Long Beach, California, 90808, United States

Location

Clinical Trials of Orange County, Inc.

Orange, California, 92868, United States

Location

Allergy and Asthma Consultants

Redwood City, California, 94063, United States

Location

IMMUNOe International Research Centers

Centennial, Colorado, 80112, United States

Location

All Seasons Allergy and Asthma Center, P.A.

Fort Walton Beach, Florida, 32547, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Brookstone Centre Parkway

Columbus, Georgia, 31904, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Northern Illinois Research Associates

DeKalb, Illinois, 60115, United States

Location

Sneeze, Wheeze & Itch Associates LLC

Normal, Illinois, 61761, United States

Location

Nassim, McMonigle, Mescia & Associates

New Albany, Indiana, 47150, United States

Location

Grand Blanc Medical

Grand Blanc, Michigan, 48439, United States

Location

Craig A. Spiegel MD

Bridgeton, Missouri, 63044, United States

Location

Midwest Allergy and Asthma center

Omaha, Nebraska, 68130, United States

Location

The Asthma & Allergy Center, P.C.

Papillion, Nebraska, 68046, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

St. Elizabeth Health Center

Utica, New York, 13502, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Allergy, Asthma and clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Eminence Research, LLC

Oklahoma City, Oklahoma, 73139, United States

Location

Asthma and Allergy Research Associates

Upland, Pennsylvania, 19013, United States

Location

National Allergy, Asthma, and Uticaria Centers

Charleston, South Carolina, 29407, United States

Location

AAC Research - PC

Charleston, South Carolina, 29414, United States

Location

ADAC Research, PA

Greenville, South Carolina, 29607, United States

Location

The Asthma Institute, PLLC

Chattanooga, Tennessee, 37421, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Isis Clinical Research, LLC

Austin, Texas, 78731, United States

Location

Sirius Clinical Research, LLC

Austin, Texas, 78759, United States

Location

Hill Country Family Medical Center

Boerne, Texas, 78006, United States

Location

TTS Research

Boerne, Texas, 78006, United States

Location

Allergy/Immunology Research Center of North Texas

Dallas, Texas, 75230, United States

Location

Dallas Allergy Immunology Research

Dallas, Texas, 75230, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Breath of Life Research Institute

Katy, Texas, 77450, United States

Location

Live Oak Allergy and Asthma Clinic

Live Oak, Texas, 78233, United States

Location

Quality Assurance Research Center, Inc.

San Antonio, Texas, 78205, United States

Location

Southwest Allergy and Asthma, P.A.

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

Allergy & Asthma Care of Waco

Waco, Texas, 76712, United States

Location

Allergy and Asthma Research Institute

Waco, Texas, 76712, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Colonial Heights Pediatrics

Colonial Heights, Virginia, 23834, United States

Location

Bellingham Asthma, Allergy, & Immunology Clinic

Bellingham, Washington, 98225, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Levalbuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion

1-866-503-6351

Study Officials

• Respiratory Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 28, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-07

Locations

US (46)