Clinical trial NCT00073814: Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Official title: An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: levalbuterol
pediatric
asthma
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2003-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

Detailed description: This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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 and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules
* Subject, male or female, between the ages of 4 to 11 yrs
* Female subjects 8 yrs or older will have a negative serum pregnancy test
* Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
* Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 mos. prior to study start
* Must be in good health with the exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
* Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc
* Subject's p/l guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, and demonstrate how to use the MiniWright PEF meter

Exclusion Criteria

* Female subject who is pregnant or lactating
* Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
* Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
* Have travel commitments during the study that would interfere with trial measurements or compliance or both
* Have a history of hospitalization for asthma within 60 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
* Have 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 albuterol sulfate administration is contraindicated
* Have currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to study start
* Have a history of cancer
* Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol
* Have a history of substance abuse or drug abuse within 12 months preceding V1 or a positive urine drug screening at study start
* Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
* Has suffered from a clinically significant upper or lower respiratory tract infection in the 2 wks prior to study start
* Have a history of cigarette smoking or use of any tobacco products
* Subject who is a relative of a staff member

Primary outcomes:
measure: was peak percent change in FEV1 from visit predose averaged over the double-blind period
timeFrame: Week 0, 2, 4
Secondary outcomes:
measure: under the FEV1 percent change from visit predose curve averaged over the double-blind period
timeFrame: Week 0, 2, 4
measure: peak change and peak percent change in FEV1 from visit predose to each visit
timeFrame: Week 0, 2, 4
measure: peak change in FEV1 from visit predose to each visit
timeFrame: Week 0, 2, 4
measure: peak percent change in FEV1 from study baseline over the double blind period
timeFrame: Week 0, 2, 4
measure: time to peak change
timeFrame: Week 0, 2, 4
measure: peak percent of predicted FEV1 at each visit and over the double-blind period
timeFrame: Week 0, 2, 4
measure: area under the FEV1 percent change from predose curve at each visit
timeFrame: Week 0, 2, 4
measure: area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period
timeFrame: Week 0, 2, 4
measure: percent of predicted FEV1 AUC at each visit
timeFrame: Week 0, 2, 4
measure: percent change in predose FEV1 from study baseline at each visit
timeFrame: Week 0, 2, 4
measure: number and percent of responders
timeFrame: Week 0, 2, 4
measure: time to onset of response and duration of response
timeFrame: Week 0, 2, 4
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Adolescent & Pediatric Associates, PC
state: Alabama
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, PA
state: Arkansas
city: Corona
country: United States
facility: Integrated Research Group
state: California
city: Huntington Beach
country: United States
facility: Allergy & Asthma Specialists Medical Group
state: California
city: Long Beach
country: United States
facility: Asthma, Allergy & Respiratory Care Center
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Orange
country: United States
facility: CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology
state: California
city: Orange
country: United States
facility: Clinical Trials of Orange County
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: Signal Hill
country: United States
facility: West Coast Clinical Trials, Inc.
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Medical Group of Diablo Valley, Inc.
state: California
city: Colorado Springs
country: United States
facility: Asthma & Allergy Associates
state: Colorado
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Lawrenceville
country: United States
facility: The Allergy & Asthma Clinical Research Center
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Laboratories of Savannah, Inc.
state: Georgia
city: Louisville
country: United States
facility: Department of Pediatric Critical Care, Kosair Children's Hospital
state: Kentucky
city: Bogalusa
country: United States
facility: The Pediatric Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Doctor's Care
state: Louisiana
city: New Orleans
country: United States
facility: Dolby Providers, Inc
state: Louisiana
city: Bridgeton
country: United States
facility: Radiant Research
state: Missouri
city: Livingston
country: United States
facility: Essex-Morris Pediatric Group
state: New Jersey
city: Princeton
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Summit
country: United States
facility: Summit Pediatric Pulmonology
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico, Health Sciences Center
state: New Mexico
city: Ithaca
country: United States
facility: Pulmonary Associates of Mobile, PC
state: New York
city: Asheville
country: United States
facility: Regional Allergy & Asthma Consultants, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Rainbow Babies & Children's Hospital
state: Ohio
city: University Heights
country: United States
facility: Dr. Senders & Associates
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Lake Oswego
country: United States
facility: Allergy & Asthma and Dermatology Research Center
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: Bellevue Pediatric Association
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Allergy & Asthma Consultants
state: South Carolina
city: Knoxville
country: United States
facility: Allergy, Asthma & Sinus Center, PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University ASAP Research
state: Tennessee
city: Dallas
country: United States
facility: Pediatric Allergy/Immunology Associates
state: Texas
city: Fort Worth
country: United States
facility: North Texas Institute for Clinical Trials
state: Texas
city: Houston
country: United States
facility: Allergy & Asthma Associates
state: Texas
city: Houston
country: United States
facility: Breath of Life Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Burke
country: United States
facility: PI- Coor Clinical Research, LLC
state: Virginia
city: Kirkland
country: United States
facility: Allergy & Asthma Associates
state: Washington
Study officials:
References: