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

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ClinicalTrials.gov Identifier: NCT00456677
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Rauno Joks, State University of New York - Downstate Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: minocycline Drug: Placebos Phase 2

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double blind, placebo-controlled. crossover study
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
Study Start Date : June 1996
Actual Primary Completion Date : October 1, 2007
Actual Study Completion Date : October 1, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Minocycline
Addition of minocycline 150 mg po twice daily to current asthma treatment regimen.
Drug: minocycline
addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
Other Name: Minocin
Placebo Comparator: Placebos
Addition of placebo capsules po twice daily to current asthma treatment regimen
Drug: Placebos
Addition of oral placebo capsule in addition to standard of care regimen
Other Name: oral placebo capsules



Primary Outcome Measures :
  1. Decrease in oral steroid therapy requirements. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women

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): NCT00456677


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

Responsible Party: Rauno Joks, Associate Professor of Clinical Medicine, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT00456677     History of Changes
Other Study ID Numbers: Heikki31
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rauno Joks, State University of New York - Downstate Medical Center:
minocycline
asthma
oral corticosteroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents