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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 because the information has not been verified recently.
Verified September 2007 by State University of New York - Downstate Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:
NCT00536042
First received: September 26, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

  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

No publications provided

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

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

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 May 22, 2013