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

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ClinicalTrials.gov Identifier: NCT00536042
Recruitment Status : Enrolling by invitation
First Posted : September 27, 2007
Last Update Posted : April 17, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Minocycline Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 1997
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: minocycline
addition of minocycline to standard asthma care as add-on therapy: 150 mg bid to 250 mg bid for up to one year
Drug: Minocycline
addition of 150 mg to 250 mg po bid to standard asthma care regiment
Other Name: Minocin

Outcome Measures

Primary Outcome Measures :
  1. Improvement in FEV1 on spirometry [ Time Frame: one year ]

Secondary Outcome Measures :
  1. decrease in total serum IgE [ Time Frame: one year ]
  2. decrease in oral steroid requirements [ Time Frame: one year ]
  3. improvement in quality of life scores [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rauno Joks, Associate Professor of Clinical Medicine, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT00536042     History of Changes
Other Study ID Numbers: open mino
First Posted: September 27, 2007    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rauno Joks, 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