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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2007 by State University of New York - Downstate Medical Center. Recruitment status was Active, not recruiting

First Received on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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

ClinicalTrials.gov Identifier:	NCT00456677 History of Changes
Other Study ID Numbers:	Heikki31
Study First Received:	April 4, 2007
Last Updated:	April 4, 2007
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:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Anti-Inflammatory Agents
Minocycline
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012