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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rauno Joks, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier:
NCT00456677
First received: April 4, 2007
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Asthma
Drug: minocycline
Drug: Placebos
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Double blind, placebo-controlled. crossover study
Masking: Participant, Care Provider
Primary Purpose: Treatment
Official Title: Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma

Resource links provided by NLM:


Further study details as provided by State University of New York - Downstate Medical Center:

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

Secondary Outcome Measures:
  • improvement in symptoms scores [ Time Frame: 8 weeks ]
    Asthma Quality of Lifes Scores (AQLQ)

  • improvement in spriometric parameters [ Time Frame: 8 weeks ]
    improvement in spirometric parameters including FEV1, FVC, FEV1/FVC, FEF25-75

  • improvement in morning and evening peak flow [ Time Frame: 8 weeks ]
  • decrease in rescue inhaler usage [ Time Frame: 8 weeks ]

Enrollment: 20
Study Start Date: June 1996
Study Completion Date: October 1, 2007
Primary Completion Date: October 1, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: April 4, 2007
Last Updated: April 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on April 28, 2017