We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536042
First Posted: September 27, 2007
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rauno Joks, State University of New York - Downstate Medical Center
  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: 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

Resource links provided by NLM:


Further study details as provided by Rauno Joks, 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: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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

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 Submitted: September 26, 2007
First Posted: September 27, 2007
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:
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
Minocycline
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents