Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy
OBJECTIVES: I. Determine whether albuterol increases strength in patients with facioscapulohumeral dystrophy as measured by quantitative voluntary isometric contraction testing.
II. Determine whether albuterol increases muscle mass in this patient population as determined by 24 hour urinary creatinine excretion and dual energy x-ray absorptiometry (DEXA).
III. Examine the long term safety of albuterol in this patient population.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||January 1998|
|Estimated Study Completion Date:||September 2000|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized into one of three treatment groups. The first group receives placebo. The second group receives low dose albuterol orally every 12 hours. The third group receives high dose albuterol orally every 12 hours. Treatment continues for 52 weeks unless unacceptable side effects occur.
All patients return for follow up assessments at weeks 4, 12, 24, and 52.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004685
|Study Chair:||John T. Kissel||Ohio State University|