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

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: Levalbuterol
Drug: Placebo
Drug: Levalbuterol UDV TID

Registration Number: NCT00809757

Lead Sponsor: Sumitomo Pharma America, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 197

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Levalbuterol	90 ug Levalbuterol (2 actuations)
3	Placebo	Placebo
2	Levalbuterol UDV TID	0.31 ug Levalbuterol UDV TID

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)	Baseline, Visit 4 (Week 4)	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.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3	Baseline, Visit 3, pre -dose (approximately 14 days after randomization)
Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4	Baseline, Visit 3 (the week prior to Visit 3) and Visit 4	Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers.
Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period	Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)	Number of subjects using rescue medication during the treatment period
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	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 from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3	Baseline, Visit 3, pre-dose (approximately 14 days after randomization)
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4	Visit 4: pre-dose (approximately 28 days after randomization) , 30 minutes post-dose, 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2	Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
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)	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 3 is defined as the mean daily composite scores for 7 days prior to Visit 3.
Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2	Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose	Peak expiratory flow (PEF) measures how fast a person can breathe out using the greatest effort
Investigator Global Assessment - Question 1	Visit 4 (End of 28 day treatment period)	Since the start of the study, how would you evaluate the child's asthma symptoms?
Investigator Global Assessment - Question 2	Visit 4 (End of 28 day treatment period)	Since the start of the study, how would you evaluate your ability to manage the subject's asthma?
Change From Baseline to Visit 2 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	The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 2 to Visit 3 is defined as the mean of the daily composite scores from Visit 2 (inclusive) to the day prior to Visit 3.
Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Daytime and Nighttime Asthma Symptom Score as Measured by the Pediatric Asthma Questionnaire	The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
Caregiver Global Assessment - Question 1	Visit 4 (End of 28 day treatment period)	Since the start of the study, how would you evaluate your child's asthma symptoms?
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used	Visit 2 to Visit 3 (the first 2 weeks of the study), Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score	Visit 3 and Visit 4 (End of 28 day treatment period)	The PACQLQ composite score was calculated as the mean of the scores of the 13 individual questions. Composite scores could range from 1 to 7. Lower scores indicated greater impact of disease on quality of life.
Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment	Baseline, Visit 3 (Week 3)	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 3 is defined as the mean of the daily composite scores in the 7 days prior to Visit 3.
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	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 from Visit 3 to Visit 4 is defined as the mean of the daily composite scores from Visit 3 (inclusive) to the day prior to Visit 4.
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)	The daily composite score is the sum of the scores of 7 items: Difficulty Breathing, Cough, Wheeze, Activity Limitation, Level of Activity Limitation, Overall Symptom Score, and Nighttime Asthma. The range for the PAQ is 0 (no symptoms) to 27 (severe symptoms). The mean daily composite score at Visit 4 is defined as the mean daily composite scores in the 7 days prior to Visit 4.
Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4	Baseline, Visit 4, pre -dose (approximately 28 days after randomization)
Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)	Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)	Mean of the daily pre-dose PEF values in the week prior to visit in those subjects aged 24 to \<48 months capable of performing acceptable and reproducible PEF maneuvers.
Caregiver Global Assessment - Question 3	Visit 4 (End of 28 day treatment period)	Overall I was: Very satisfied with the control of the child's asthma symptoms while enrolled in this study, Moderately satisfied with the control of the child's asthma symptoms while enrolled in this study, Slightly satisfied with the control of the child's asthma symptoms while enrolled in this study, Not satisfied with the control of the child's asthma symptoms while enrolled in this study or answer Missing
Caregiver Global Assessment - Question 2	Visit 4 (End of 28 day treatment period)	Since the start of the study, how would you evaluate your ability to manage your child's asthma?
Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used	Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)
Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week	Visit 2 to Visit 3 (the first 2 weeks of the study) , Visit 3 to Visit 4 (the second 2 weeks of the study), Visit 2 to Visit 4 (the entire 4 weeks of the study)

Trial Locations

Locations (46): Dayton Clinical Research
🇺🇸
Dayton, Ohio, United States
ADAC Research, PA
🇺🇸
Greenville, South Carolina, United States
Sneeze, Wheeze & Itch Associates LLC
🇺🇸
Normal, Illinois, United States
St. Elizabeth Health Center
🇺🇸
Utica, New York, United States
National Allergy, Asthma, and Uticaria Centers
🇺🇸
Charleston, South Carolina, United States
Asthma and Allergy Research Associates
🇺🇸
Upland, Pennsylvania, United States
The Asthma & Allergy Center, P.C.
🇺🇸
Papillion, Nebraska, United States
Isis Clinical Research, LLC
🇺🇸
Austin, Texas, United States
Northern Illinois Research Associates
🇺🇸
DeKalb, Illinois, United States
Grand Blanc Medical
🇺🇸
Grand Blanc, Michigan, United States
The Asthma Institute, PLLC
🇺🇸
Chattanooga, Tennessee, United States
Live Oak Allergy and Asthma Clinic
🇺🇸
Live Oak, Texas, United States
AAC Research - PC
🇺🇸
Charleston, South Carolina, United States
Craig A. Spiegel MD
🇺🇸
Bridgeton, Missouri, United States
Allergy & Asthma Care of Waco
🇺🇸
Waco, Texas, United States
Brookstone Centre Parkway
🇺🇸
Columbus, Georgia, United States
Allergy and Asthma Research Institute
🇺🇸
Waco, Texas, United States
Nassim, McMonigle, Mescia & Associates
🇺🇸
New Albany, Indiana, United States
Sirius Clinical Research, LLC
🇺🇸
Austin, Texas, United States
Western Sky Medical Research
🇺🇸
El Paso, Texas, United States
Maimonides Medical Center
🇺🇸
Brooklyn, New York, United States
Midwest Allergy and Asthma center
🇺🇸
Omaha, Nebraska, United States
Breath of Life Research Institute
🇺🇸
Katy, Texas, United States
Hill Country Family Medical Center
🇺🇸
Boerne, Texas, United States
Bellingham Asthma, Allergy, & Immunology Clinic
🇺🇸
Bellingham, Washington, United States
PI-Coor Clinical Research, LLC
🇺🇸
Burke, Virginia, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Dallas Allergy Immunology Research
🇺🇸
Dallas, Texas, United States
Cincinnati Children's Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Allergy, Asthma and clinical Research Center
🇺🇸
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Eminence Research, LLC
🇺🇸
Oklahoma City, Oklahoma, United States
Allergy/Immunology Research Center of North Texas
🇺🇸
Dallas, Texas, United States
Quality Assurance Research Center, Inc.
🇺🇸
San Antonio, Texas, United States
Sylvana Research Associates
🇺🇸
San Antonio, Texas, United States
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, California, United States
All Seasons Allergy and Asthma Center, P.A.
🇺🇸
Fort Walton Beach, Florida, United States
TTS Research
🇺🇸
Boerne, Texas, United States
Southwest Allergy and Asthma, P.A.
🇺🇸
San Antonio, Texas, United States
Colonial Heights Pediatrics
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Colonial Heights, Virginia, United States
Palm Beach Research Center
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West Palm Beach, Florida, United States
IMMUNOe International Research Centers
🇺🇸
Centennial, Colorado, United States