Open-Label Trial of the Use of Minocycline in the Treatment of Asthma
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 26, 2007 | ||||
| Last Updated Date | September 26, 2007 | ||||
| Start Date ICMJE | October 1997 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Improvement in FEV1 on spirometry [ Time Frame: one year ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Open-Label Trial of the Use of Minocycline in the Treatment of Asthma | ||||
| Official Title ICMJE | 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 Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Drug: minocycline
add-on therapy: 150 mg bid to 250 mg bid for up to one year |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | March 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00536042 | ||||
| Other Study ID Numbers ICMJE | open mino | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | State University of New York - Downstate Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | State University of New York - Downstate Medical Center | ||||
| Verification Date | September 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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