Inflammatory Markers in Exhaled Breath Condensates From A... | NCT01246414

Studies
Inflammatory Markers in Exhaled Breath Condensates From Asthmatic Patients

NCT01246414

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Nov 23, 2010Estimated

Enrollment

38Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Thailand

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

Nov 2010

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

Jan 2010

Primary Completion Date

Apr 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Nov 22, 2010

First Posted Date

Nov 23, 2010Estimated

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

Nov 22, 2010

Last Update Posted Date

Nov 23, 2010Estimated

Name	Class
Mahidol University	OTHER

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

This study aims to compare the inflammatory mediators in exhaled breathe condensates from allergic and non-allergic asthmatic patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Allergic asthma		Patients with allergic asthma
Non-allergic asthma		Patients with non-allergic asthma
Non-asthmatic controls		Non-asthmatic controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of inflammatory cytokines in exhaled breathe condensates		4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have been diagnosed as asthma at least 6 months before enrolled to the study
Known skin prick test results to aeroallergens ; either positive or negative
15-65 years of age

Exclusion Criteria:

On oral or inhaled corticosteroids within 1 month before the study
Having asthma exacerbation
Being pregnant
Suffering from severe systemic disease/ in bad health

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Asthmatic patients in Allergy clinic, King Chulalongkorn Memorial Hospital (10 allergic and 10 non-allergic) and 10 non-asthmatic controls will be enrolled to this study to collect exhaled breathe condensates (EBC) and measure levels of inflammatory cytokines in EBC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jettanong Klaewsongkram, MD	Chulalongkorn University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chulalongkorn University		Bangkok		10330	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23998235	Derived	Boonpiyathad S, Pornsuriyasak P, Buranapraditkun S, Klaewsongkram J. Interleukin-2 levels in exhaled breath condensates, asthma severity, and asthma control in nonallergic asthma. Allergy Asthma Proc. 2013 Sep-Oct;34(5):e35-41. doi: 10.2500/aap.2013.34.3680.

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