NCT00536042

Brief Summary

The tetracycline minocycline has, in addition to its anti-infective properties, anti-inflammatory properties which may be of use in the treatment of asthma. This study evaluates the benefit of minocycline as add-on therapy for adults with asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Oct 1997

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

11.7 years

First QC Date

September 26, 2007

Last Update Submit

March 9, 2020

Conditions

Asthma

Keywords

minocyclineasthmaoral steroidsIgE

Outcome Measures

Primary Outcomes (1)

  • Improvement in FEV1 on spirometry

    one year

Secondary Outcomes (3)

  • decrease in total serum IgE

    one year

  • decrease in oral steroid requirements

    one year

  • improvement in quality of life scores

    one year

Study Arms (1)

minocycline

EXPERIMENTAL

addition of minocycline to standard asthma care as add-on therapy: 150 mg bid to 250 mg bid for up to one year

Drug: Minocycline

Interventions

MinocyclineDRUG

addition of 150 mg to 250 mg po bid to standard asthma care regiment

Also known as: Minocin
minocycline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (ages 18 to 75 yrs)
  • Mild to severe asthma
  • History of or current oral steroid use to control asthma atopy

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Asthmacyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Medicine

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

October 1, 1997

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

US(1)