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

NCT00456677 | Completed Phase 2

• 1 other identifier: Heikki31
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

minocycline; asthma; oral corticosteroids

Outcome Measures

Primary Outcomes (1)

• Decrease in oral steroid therapy requirements.

  8 weeks

Secondary Outcomes (4)

• improvement in symptoms scores

  8 weeks

• improvement in spriometric parameters

  8 weeks

• improvement in morning and evening peak flow

  8 weeks

• decrease in rescue inhaler usage

  8 weeks

Study Arms (2)

Minocycline

EXPERIMENTAL

Addition of minocycline 150 mg po twice daily to current asthma treatment regimen.

Drug: minocycline

Placebos

PLACEBO COMPARATOR

Addition of placebo capsules po twice daily to current asthma treatment regimen

Drug: Placebos

Interventions

minocycline DRUG

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

Also known as: Minocin

Minocycline

Placebos DRUG

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

Also known as: oral placebo capsules

Placebos

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Asthma; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Rauno Joks, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Model Details: Double blind, placebo-controlled. crossover study

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 5, 2007
• Study Start: June 1, 1996
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)