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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by State University of New York - Downstate Medical Center.
Recruitment status was:  Active, not recruiting
Information provided by:
State University of New York - Downstate Medical Center Identifier:
First received: September 26, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
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
Drug: minocycline
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Resource links provided by NLM:

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:
    Drug: minocycline
    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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00536042

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
Principal Investigator: Rauno Joks, MD State University of New York - Downstate Medical Center
  More Information Identifier: NCT00536042     History of Changes
Other Study ID Numbers: open mino
Study First Received: September 26, 2007
Last Updated: September 26, 2007

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents processed this record on March 24, 2017