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

Sponsored by:	State University of New York - Downstate Medical Center
Information provided by:	State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:	NCT00536042

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: minocycline	Phase II

MedlinePlus related topics: Asthma

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Further study details as provided by State University of New York - Downstate Medical Center:

Primary Outcome Measures:

Improvement in FEV1 on spirometry [ Time Frame: one year ]

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 ]

Estimated Enrollment:	20
Study Start Date:	October 1997
Estimated Study Completion Date:	March 2008

Intervention Details:

add-on therapy: 150 mg bid to 250 mg bid for up to one year

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536042

Locations

United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203

Sponsors and Collaborators

State University of New York - Downstate Medical Center

Investigators

Principal Investigator:

Rauno Joks, MD

State University of New York - Downstate Medical Center

More Information

Study ID Numbers:	open mino
Study First Received:	September 26, 2007
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00536042
Health Authority:	United States: Institutional Review Board

Keywords provided by State University of New York - Downstate Medical Center:

minocycline
asthma
oral steroids
IgE

Study placed in the following topic categories:

Minocycline
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Immune System Diseases

Bronchial Diseases
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009