Open-Label Trial of the Use of Minocycline in the Treatment of Asthma
Information source: State University of New York - Downstate Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: minocycline (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: State University of New York - Downstate Medical Center Official(s) and/or principal investigator(s):
Rauno Joks, MD, Principal Investigator, Affiliation: State University of New York - Downstate Medical Center
Summary
The tetracycline minocycline has, in addition to its anti-infective properties,
anti-inflammatory properties which may be of use in the treatment of asthma. This study
evaluates the benefit of minocycline as add-on therapy for adults with asthma.
Clinical Details
Official title: Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Primary outcome: Improvement in FEV1 on spirometry
Secondary outcome: decrease in total serum IgEdecrease in oral steroid requirements improvement in quality of life scores
Detailed description:
Adult asthmatic (ages 18 to 75 years) with a history of moderate to severe persistent asthma
are given minocycline capsules as add-on therapy for treatment of asthma. Treatment is for
one year. Dosing begins at 150 mg twice daily and can increase every eight weeks by 50mg BID
to a maximum of 250 mg twice daily. This is as per patient tolerance as minocycline can cause
dizziness and stomach upset, as well as effects of liver enzymes. Patients undergo routine
blood toxicity screens every two months, at which time spirometry is performed Exclusion
criteria: pregnant women (adequate contraception in mandated) previous history of
hypersensitivity to tetracyclines, chronic liver disease Outcome measures: improvement in
FEV1 and other spirometric parameters, decrease in oral steroid requirements, change in total
serum IgE, improvement in quality of life
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults (ages 18 to 75 yrs)
- Mild to severe asthma
- History of or current oral steroid use to control asthma atopy
Exclusion Criteria:
- Pregnant women
Locations and Contacts
SUNY Downstate Medical Center, Brooklyn, New York 11203, United States
Additional Information
Starting date: October 1997
Ending date: March 2008
Last updated: September 26, 2007
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