To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.
This study is a double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in adult subjects with acute reversible airways disease. Approximately 600 subjects will be enrolled and study participation will consist of 2 periods: Period I (Acute Period): Double-blind treatment in the Emergency Department (ED) or Clinic until disposition, for a maximum of 24 hours of double-blind treatment and Period II (Post-Acute Period): Subjects discharged from the ED or Clinic will continue double blind treatment (with the same treatment provided as rescue medication as MDI) for approximately 10 days. Subjects will be contacted by telephone 30 days post discharge to assess relapse. 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
DOUBLE
Enrollment
627
levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated. Period II: TID for 3 days (same time of day), then PRN to TID for 7 days
Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated. Period II: TID for 3 days then PRN to TID for 7 days
Unnamed facility
Hoover, Alabama, United States
Unnamed facility
Montgomery, Alabama, United States
Time to meet discharge criteria (functional airway improvement)during the first 3 hours of Period I.
Time frame: 24 hours
FEV1 (Period I): Serial spirometry, maximum FEV1, time to maximum FEV1, baseline FEV1 severity on subject response; % responders, no. nebulizations to meet discharge criteria, rate of hospitalization, time to admit decision, rate for increased care
Time frame: Day 0 (5-10 min after every dose)
FEV1 (Period II): Spirometry, average FEV1; distribution of subject responses; rate of relapse; blinded study medication; length of stay in ED or Clinic during Period I; length of hospitalization, cost of care
Time frame: Days 3, 10
Investigator and subject global evaluations, subject preference
Time frame: Days 3, 10
Subject reported beta-mediated side effects
Time frame: Days 3, 10
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Unnamed facility
Encinitas, California, United States
Unnamed facility
Fresno, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Tampa, Florida, United States
...and 18 more locations