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Multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study of up to four weeks in duration. The study consisted of a screening visit followed by a one-week single blind placebo period. At next visit, each subject was randomized to one of four treatment groups: 90 mcg levalbuterol, 180 mcg levalbuterol, 180 mcg racemic albuterol, or placebo. All study medication was administered as 2 actuations 4 times a day for 21 days.
Full description
This was a multicenter, randomized, double-blind, placebo- and active-controlled, Phase II, parallel-group study up to four weeks in duration. Seven days of QID (four times a day) single-blind, placebo administration (via metered dose inhaler (MDI)) was followed by 21 days of QID double-blind treatment. During the single-blind period, rescue medication consisted of racemic albuterol MDI (90 mcg per actuation) for all subjects. During the double-blind period, rescue medication consisted of double-blind levalbuterol MDI (45 mcg per actuation) for all subjects in the levalbuterol treatment groups or double-blind racemic albuterol MDI (90 mcg per actuation) for all subjects in the racemic albuterol and placebo treatment groups.The study consisted of two periods, an optional follow-up visit, and a final telephone evaluation. This study was previously conducted 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.
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Exclusion criteria
Corticosteroids - Parenteral = 30 days wash out period. Adrenergic bronchodilators - Inhaled, short-acting = greater than or equal to 7 hours wash out period, Nebulized, short acting = greater than or equal to 10 hours wash out period, Inhaled, long acting = greater than or equal to 24 hours wash out period, Oral QID or TID preparation =greater than or equal to 24 hours wash out period, Oral BID preparations = greater than or equal to 36 hours wash out period, Nonprescription asthma medications = greater than or equal to 48 hours wash out period, Ipratropium bromide = greater than or equal to 48 hours wash out period (Study medication and rescue medication were allowed to be used as needed but were required to be with-held prior to Study visits according to the schedule noted above)
Primary purpose
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Interventional model
Masking
146 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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