Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

This study is ongoing, but not recruiting participants.

First Received: April 4, 2007 No Changes Posted

Sponsor:	State University of New York - Downstate Medical Center
Information provided by:	State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:	NCT00456677

Purpose

Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.

Condition	Intervention	Phase
Asthma	Drug: minocycline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Decrease in oral steroid therapy requirements.

Secondary Outcome Measures:

improvement in symptoms scores
improvement in spirometric outcomes
improvement in morning and evening peak flow
decrease in rescue inhaler usage

Estimated Enrollment:	20
Study Start Date:	June 1996
Estimated Study Completion Date:	October 2007

Detailed Description:

This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).

Eligibility

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

Criteria

Inclusion Criteria:

Adult asthmatics
History of or current use of oral steroids to control symptoms

Exclusion Criteria:

Pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456677

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

No publications provided

Study ID Numbers:	Heikki31
Study First Received:	April 4, 2007
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00456677 History of Changes
Health Authority:	United States: Institutional Review Board

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

minocycline
asthma
oral corticosteroids

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Minocycline
Bronchial Diseases
Immune System Diseases
Asthma
Pharmacologic Actions
Anti-Bacterial Agents

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010