Evaluation of the Utility of Minocycline as an Anti-Infla... | NCT00456677

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

NCT00456677

Sponsor

State University of New York - Downstate Medical Center

Status

Completed

Last Update Posted

Apr 18, 2017Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Asthma

Interventions

minocycline
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1996

Primary Completion Date

Oct 1, 2007Actual

Completion Date

Oct 1, 2007Actual

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2017

Last Update Posted Date

Apr 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rauno Joks, Associate Professor of Clinical Medicine, State University of New York - Downstate Medical CenterPrincipal Investigator

Lead Sponsor

State University of New York - Downstate Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
minocycline	Drug	addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.	Minocycline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease in oral steroid therapy requirements.		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
improvement in symptoms scores	Asthma Quality of Lifes Scores (AQLQ)	8 weeks
improvement in spriometric parameters	improvement in spirometric parameters including FEV1, FVC, FEV1/FVC, FEF25-75

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rauno Joks, MD	State University of New York - Downstate Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Downstate Medical Center		Brooklyn	New York	11203	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
C562573	cyclopia sequence

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008911	Minocycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided