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Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy

Descriptive Information
Brief Title † Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy
Official Title †
Brief Summary 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.
Detailed Description 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
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Muscular Dystrophy, Facioscapulohumeral
Intervention † Drugalbuterol
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 90
Start Date † January 1998
Completion Date September 2000
Primary Completion Date
Eligibility Criteria † PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Facioscapulohumeral dystrophy Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris Weakness of scapular stabilizers or foot dorsiflexors Weakness of grade 2 or worse in the arm using the upper extremity grading scale No other neuromuscular diseases that may mimic the clinical presentation of facioscapulohumeral dystrophy: Ptosis or ophthalmoparesis (other than congenital strabismus) Elbow contractures Strictly unilateral weakness Dermatomyositis-like skin rash Symmetric distal sensory loss Muscle biopsy findings of mitochondrial myopathy, chronic denervation, dermatomyositis, inclusion body myositis, or congenital myopathy Electromyographic (EMG) findings of myotonia, fasciculations, or neurogenic motor unit potentials --Prior/Concurrent Therapy-- Endocrine therapy: No prior long term use of oral corticosteroids for more than 1 year At least 3 months since prior use of corticosteroids No concurrent use of immunosuppressive agents Surgery: No concurrent surgeries Other: No concurrent use of sympathomimetic agents, antidepressants, or beta receptor blockers --Patient Characteristics-- Age: 18 to 80 Performance status: Ambulatory Cardiovascular: No cardiovascular disease, including hypertension and coronary artery disease Other: Not pregnant or nursing No concurrent uncontrolled medical or psychological condition
Gender Both
Ages 18 Years - 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT00004685
Organization ID 199/13285
Secondary IDs †† OSURF-96H0022, OSURF-FDR001293
Responsible Party
Study Sponsor † Ohio State University
Collaborators ††
Investigators † Study Chair: John T. Kissel, Ohio State University
Information Provided By
Verification Date March 1999
First Received Date † February 24, 2000
Last Updated Date March 24, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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