Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
was peak percent change in FEV1 from visit predose averaged over the double-blind period
Time frame: Week 0, 2, 4
under the FEV1 percent change from visit predose curve averaged over the double-blind period
Time frame: Week 0, 2, 4
peak change and peak percent change in FEV1 from visit predose to each visit
Time frame: Week 0, 2, 4
peak change in FEV1 from visit predose to each visit
Time frame: Week 0, 2, 4
peak percent change in FEV1 from study baseline over the double blind period
Time frame: Week 0, 2, 4
time to peak change
Time frame: Week 0, 2, 4
peak percent of predicted FEV1 at each visit and over the double-blind period
Time frame: Week 0, 2, 4
area under the FEV1 percent change from predose curve at each visit
Time frame: Week 0, 2, 4
area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period
Time frame: Week 0, 2, 4
percent of predicted FEV1 AUC at each visit
Time frame: Week 0, 2, 4
percent change in predose FEV1 from study baseline at each visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Adolescent & Pediatric Associates, PC
Montgomery, Alabama, United States
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, United States
Integrated Research Group
Corona, California, United States
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, United States
Asthma, Allergy & Respiratory Care Center
Long Beach, California, United States
Madera Family Medical Group
Madera, California, United States
Southern California Research
Mission Viejo, California, United States
CHOC, PSF, AMC Disision of Allergy, Asthma & Immunology
Orange, California, United States
Clinical Trials of Orange County
Orange, California, United States
Allergy Associates Medical Group
San Diego, California, United States
...and 35 more locations
Time frame: Week 0, 2, 4
number and percent of responders
Time frame: Week 0, 2, 4
time to onset of response and duration of response
Time frame: Week 0, 2, 4