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Tracking Information | |||||
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First Received Date † | September 26, 2007 | ||||
Last Updated Date | September 26, 2007 | ||||
Start Date † | October 1997 | ||||
Current Primary Outcome Measures † |
Improvement in FEV1 on spirometry [ Time Frame: one year ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Open-Label Trial of the Use of Minocycline in the Treatment of Asthma | ||||
Official Title † | Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma | ||||
Brief 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. |
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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 |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study | ||||
Condition † | Asthma | ||||
Intervention † | Drug: minocycline | ||||
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. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 20 | ||||
Estimated Completion Date | March 2008 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00536042 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | State University of New York - Downstate Medical Center | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | State University of New York - Downstate Medical Center | ||||
Verification Date | September 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |