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

NCT ID: NCT00536042

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-10-31
• Study Completion Date: 2009-06-30

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

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

minocycline

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

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

addition of 150 mg to 250 mg po bid to standard asthma care regiment

Interventions

Minocycline

addition of 150 mg to 250 mg po bid to standard asthma care regiment

Intervention Type: DRUG

Other Intervention Names

Minocin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rauno Joks, MD

Associate Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rauno Joks, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Downstate Medical Center

Locations

SUNY Downstate Medical Center

Brooklyn, New York, United States

Countries

United States

Other Identifiers

open mino

Identifier Type: -

Identifier Source: org_study_id