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OpenTrials
Completed

NCT Number: NCT00456677

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

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.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant women

Treatment and study plan

Minocycline

Drug

addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.

Other names: Minocin

Placebos

Drug

Addition of oral placebo capsule in addition to standard of care regimen

Other names: oral placebo capsules

Primary outcomes

  1. Decrease in oral steroid therapy requirements.

    Time frame: 8 weeks

Secondary outcomes

  1. improvement in symptoms scores

    Time frame: 8 weeks

    Asthma Quality of Lifes Scores (AQLQ)

  2. improvement in spriometric parameters

    Time frame: 8 weeks

    improvement in spirometric parameters including FEV1, FVC, FEV1/FVC, FEF25-75

  3. improvement in morning and evening peak flow

    Time frame: 8 weeks

  4. decrease in rescue inhaler usage

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

State University of New York - Downstate Medical Center

Other

Registry information

Acronym: Mino

Important dates

Study start
1996
Primary completion
2007
Study completion
2007
First posted
Apr 5, 2007
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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