Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

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

Intervention(s) in this Clinical Trial

• Drug: minocycline
  • add-on therapy: 150 mg bid to 250 mg bid for up to one year

Primary Measures

• Improvement in FEV1 on spirometry
  • Time Frame: one year
    

Secondary 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
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: State University of New York - Downstate Medical Center

Overall Clinical Trial Officials and Contacts

Rauno Joks, MD Principal Investigator State University of New York - Downstate Medical Center  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00536042

Study ID Number: open mino

ClinicalTrials.gov Identifier: NCT00536042

Health Authority: United States: Institutional Review Board