Open-Label Trial of the Use of Minocycline in the Treatment of Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Minocycline

• Registration Number: NCT00536042
• Lead Sponsor: State University of New York - Downstate Medical Center

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.

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

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
minocycline	Minocycline	addition of minocycline to standard asthma care as add-on therapy: 150 mg bid to 250 mg bid for up to one year

Primary Outcome Measures

Name	Time	Method
Improvement in FEV1 on spirometry	one year

Secondary Outcome Measures

Name	Time	Method
decrease in oral steroid requirements	one year
improvement in quality of life scores	one year
decrease in total serum IgE	one year

Trial Locations

Locations (1)

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States