Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease...
Date First Received: April 4, 2007
Last Updated: April 4, 2007
Verified by: State University of New York - Downstate Medical Center, April 2007
Clinical Trial Phase: Phase 2 | Start Date: June 1996
Overall Status: Active, not recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma”
Condition Keyword(s):
Intervention(s):
Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded.
A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).
Intervention(s) in this Clinical Trial
- Drug: minocycline
Outcome Measures for this Clinical Trial
Primary Measures
- Decrease in oral steroid therapy requirements.
Secondary Measures
- improvement in symptoms scores
- improvement in spirometric outcomes
- improvement in morning and evening peak flow
- decrease in rescue inhaler usage
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adult asthmatics
- History of or current use of oral steroids to control symptoms
Exclusion Criteria:
- Pregnant women
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: State University of New York - Downstate Medical Center
Overall Clinical Trial Officials and Contacts
Rauno Joks, MD Principal Investigator State University of New York - Downstate Medical Center
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00456677
Study ID Number: Heikki31
ClinicalTrials.gov Identifier: NCT00456677
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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