Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Asthma Clinical Trial

— Mino  

Official title:

Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456677
• Other study ID #: Heikki31
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: April 14, 2017
• Start date: June 1996
• Est. completion date: October 1, 2007

Study information

• Verified date: April 2017
• Source: State University of New York - Downstate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.

Description:

This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2007
• Est. primary completion date: October 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adult asthmatics

• History of or current use of oral steroids to control symptoms

Exclusion Criteria:

• Pregnant women

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• minocycline
addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
• Placebos
Addition of oral placebo capsule in addition to standard of care regimen

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in oral steroid therapy requirements.		8 weeks
Secondary	improvement in symptoms scores	Asthma Quality of Lifes Scores (AQLQ)	8 weeks
Secondary	improvement in spriometric parameters	improvement in spirometric parameters including FEV1, FVC, FEV1/FVC, FEF25-75	8 weeks
Secondary	improvement in morning and evening peak flow		8 weeks
Secondary	decrease in rescue inhaler usage		8 weeks