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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

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 ^†

decrease in total serum IgE [ Time Frame: one year ]
decrease in oral steroid requirements [ Time Frame: one year ]
improvement in quality of life scores [ Time Frame: one year ]

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.

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 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.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Estimated Completion Date

March 2008

Primary Completion Date

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

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 ^†

Principal Investigator:

Rauno Joks, MD

State University of New York - Downstate Medical Center

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.