Clinical trial NCT00809757: A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 197
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA)
timeFrame: Baseline, Visit 4 (Week 4)
Secondary outcomes:
measure: Change From Baseline to Visit 3 in Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
timeFrame: Baseline, Visit 3 (Week 3)
measure: Change From Baseline to Visit 2 to Visit 3 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
timeFrame: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
measure: Change From Baseline to Visit 3 to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessment
timeFrame: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
measure: 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)
timeFrame: Baseline, Visit 3 (Week 3)
measure: 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
timeFrame: Baseline, Visit 4 (Week 4)
measure: 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
timeFrame: The days from Visit 2 (inclusive) to the day prior to Visit 3 - approximately 14 days
measure: 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
timeFrame: The days from Visit 3 (inclusive) to the day prior to Visit 4 - approximately 14 days
measure: Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
timeFrame: Baseline, Visit 2: 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
measure: Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 3
timeFrame: Baseline, Visit 3, pre-dose (approximately 14 days after randomization)
measure: Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoint at Visit 4
timeFrame: 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
measure: Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 2
timeFrame: Baseline, Visit 2: , 30 minutes post-dose (on the day of randomization), 1 hour post-dose, 4 hours post-dose, 6 hours post-dose
measure: Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 3
timeFrame: Baseline, Visit 3, pre -dose (approximately 14 days after randomization)
measure: Percent Change From Baseline in In-Clinic Peak Expiratory Flow to Postdose Timepoints at Visit 4
timeFrame: Baseline, Visit 4, pre -dose (approximately 28 days after randomization)
measure: Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4
timeFrame: Baseline, Visit 3 (the week prior to Visit 3) and Visit 4
measure: Percent Change From Baseline in the At-Home Mean Daily Peak Expiratory Flow (PEF to Postdose Timepoint at Visit 3 and Visit 4)
timeFrame: Visit 3 (the week prior to Visit 3), Visit 4 (the week prior to Visit 4)
measure: Investigator Global Assessment - Question 1
timeFrame: Visit 4 (End of 28 day treatment period)
measure: Investigator Global Assessment - Question 2
timeFrame: Visit 4 (End of 28 day treatment period)
measure: Caregiver Global Assessment - Question 1
timeFrame: Visit 4 (End of 28 day treatment period)
measure: Caregiver Global Assessment - Question 2
timeFrame: Visit 4 (End of 28 day treatment period)
measure: Caregiver Global Assessment - Question 3
timeFrame: Visit 4 (End of 28 day treatment period)
measure: Rescue Medication Use: Number of Subjects Using Rescue Medication During the Treatment Period
timeFrame: 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)
measure: Rescue Medication Use - Change From Baseline in Mean Number of Days Used Per Week When Used
timeFrame: 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)
measure: Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week
timeFrame: 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)
measure: Rescue Medication Use - Change From Baseline in Mean Number of Doses Used Per Week During Weeks When Used
timeFrame: 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)
measure: Change From Baseline to Visit 3 and Visit 4 in the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLA) Composite Score
timeFrame: Visit 3 and Visit 4 (End of 28 day treatment period)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma Clinical Research Center
state: Arkansas
city: Cypress
country: United States
facility: West Coast Clinical Trials, LLC
state: California
city: Long Beach
country: United States
facility: Allergy & Asthma Care Center of Southern California
state: California
city: Orange
country: United States
facility: Clinical Trials of Orange County, Inc.
state: California
city: Redwood
country: United States
facility: Allergy and Asthma Consultants
state: California
city: Centennial
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Fort Walton Beach
country: United States
facility: All Seasons Allergy and Asthma Center, P.A.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Columbus
country: United States
facility: Brookstone Centre Parkway
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: DeKalb
country: United States
facility: Northern Illinois Research Associates
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates LLC
state: Illinois
city: New Albany
country: United States
facility: Nassim, McMonigle, Mescia & Associates
state: Indiana
city: Grand Blanc
country: United States
facility: Grand Blanc Medical
state: Michigan
city: Bridgeton
country: United States
facility: Craig A. Spiegel MD
state: Missouri
city: Omaha
country: United States
facility: Midwest Allergy and Asthma center
state: Nebraska
city: Papillion
country: United States
facility: The Asthma & Allergy Center, P.C.
state: Nebraska
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Utica
country: United States
facility: St. Elizabeth Health Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Eminence Research, LLC
state: Oklahoma
city: Upland
country: United States
facility: Asthma and Allergy Research Associates
state: Pennsylvania
city: Charleston
country: United States
facility: National Allergy, Asthma, and Uticaria Centers
state: South Carolina
city: Charleston
country: United States
facility: AAC Research - PC
state: South Carolina
city: Greenville
country: United States
facility: ADAC Research, PA
state: South Carolina
city: Chattanooga
country: United States
facility: The Asthma Institute, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Isis Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research, LLC
state: Texas
city: Boerne
country: United States
facility: Hill Country Family Medical Center
state: Texas
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: Dallas
country: United States
facility: Allergy/Immunology Research Center of North Texas
state: Texas
city: Dallas
country: United States
facility: Dallas Allergy Immunology Research
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Katy
country: United States
facility: Breath of Life Research Institute
state: Texas
city: Live Oak
country: United States
facility: Live Oak Allergy and Asthma Clinic
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Center, Inc.
state: Texas
city: San Antonio
country: United States
facility: Southwest Allergy and Asthma, P.A.
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy & Asthma Care of Waco
state: Texas
city: Waco
country: United States
facility: Allergy and Asthma Research Institute
state: Texas
city: Burke
country: United States
facility: PI-Coor Clinical Research, LLC
state: Virginia
city: Colonial Heights
country: United States
facility: Colonial Heights Pediatrics
state: Virginia
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy, & Immunology Clinic
state: Washington
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Respiratory Medical Director, MD
role: STUDY_DIRECTOR
References: