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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Rauno Joks, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:
NCT00536042
First received: September 26, 2007
Last updated: April 13, 2017
Last verified: April 2017

September 26, 2007
April 13, 2017
October 1997
June 2017   (Final data collection date for primary outcome measure)
Improvement in FEV1 on spirometry [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00536042 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Open-Label Trial of the Use of Minocycline in the Treatment of Asthma
Open-Label Trial of the Use of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
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.
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
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Asthma
Drug: Minocycline
addition of 150 mg to 250 mg po bid to standard asthma care regiment
Other Name: Minocin
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
Intervention: Drug: Minocycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
June 2017
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00536042
open mino
No
Not Provided
Undecided
Not Provided
Rauno Joks, State University of New York - Downstate Medical Center
State University of New York - Downstate Medical Center
Not Provided
Principal Investigator: Rauno Joks, MD State University of New York - Downstate Medical Center
State University of New York - Downstate Medical Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP