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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Sponsored by
State University of New York - Downstate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring minocycline, asthma, oral steroids, IgE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SUNY Downstate Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

minocycline

Arm Description

addition of minocycline to standard asthma care as add-on therapy: 150 mg bid to 250 mg bid for up to one year

Outcomes

Primary Outcome Measures

Improvement in FEV1 on spirometry

Secondary Outcome Measures

decrease in total serum IgE
decrease in oral steroid requirements
improvement in quality of life scores

Full Information

First Posted
September 26, 2007
Last Updated
March 9, 2020
Sponsor
State University of New York - Downstate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00536042
Brief Title
Open-Label Trial of the Use of Minocycline in the Treatment of Asthma
Official Title
Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Downstate Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
minocycline, asthma, oral steroids, IgE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
minocycline
Arm Type
Experimental
Arm Description
addition of minocycline to standard asthma care as add-on therapy: 150 mg bid to 250 mg bid for up to one year
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Minocin
Intervention Description
addition of 150 mg to 250 mg po bid to standard asthma care regiment
Primary Outcome Measure Information:
Title
Improvement in FEV1 on spirometry
Time Frame
one year
Secondary Outcome Measure Information:
Title
decrease in total serum IgE
Time Frame
one year
Title
decrease in oral steroid requirements
Time Frame
one year
Title
improvement in quality of life scores
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rauno Joks, MD
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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