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

Asthma Clinical Trial

Official title:

Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536042
• Other study ID #: open mino
• Status: Completed
• Phase: Phase 2
• Start date: October 1997
• Est. completion date: June 2009

Study information

• Verified date: March 2020
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Minocycline
addition of 150 mg to 250 mg po bid to standard asthma care regiment

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in FEV1 on spirometry		one year
Secondary	decrease in total serum IgE		one year
Secondary	decrease in oral steroid requirements		one year
Secondary	improvement in quality of life scores		one year