Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
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This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.
Condition or disease
Drug: AlbuterolDrug: Oxandrolone
Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable side effects occur. Patients will undergo testing of muscle function. All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Presence of 4q35 "small fragment" of less than 40 kb by standard DNA testing
Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris
Weakness of scapular stabilizers or foot dorsiflexors
Weakness grade 2 or worse in the arm using upper extremity grading scale
Prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months
Concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers
Known hypersensitivity to anabolic steroids
Any medical or psychological condition that would interfere with the study