Grass Sensitisation and Allergic Rhinitis in Thai Patients | NCT01686022

Studies
Grass Sensitisation and Allergic Rhinitis in Thai Patients

NCT01686022

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Sep 14, 2016Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Allergy to Grass Pollen
Allergic Rhinitis Due to Weed Pollens

Interventions

Immunoblot

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

Sep 2016

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

Oct 2012

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Sep 14, 2012

First Posted Date

Sep 17, 2012Estimated

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

Sep 13, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Name	Class
National Research Council of Thailand	OTHER_GOV

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

Allergic rhinitis patients are the patients who have nasal symptoms when triggered by indoor or outdoor allergens. Outdoor allergen can be divided into grass, tree, or weed. The type of grass or weed are different in various part of the world. The allergens from grass and weed has never been studied in Thailand. This study will find the major allergen from Bermuda grass, Johnson grass, Para grass, sedge, and ragweed, which are very common in Thailand. In addition, the investigators will study about the cross-reactivity among these group of allergen.

Detailed Description

To find the major allergen of grass and weed, the serum of patients will be used to bind with the allergen extract by immunoblot study.

The ELISA-inhibition will be used to study about cross-reactivity among various kinds of grass and weed.

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

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pollen Allergy		Pollen allergy and control will have the same intervention, ie. Skin prick test and collect serum samples.Then measure the specificIgE, immunoblot, and ELISA inhibition	Other: Immunoblot

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunoblot	Other	serum specific IgE binds to grass extract by immunoblot	Pollen Allergy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Allergic rhinitis patients age 10-50 years old
Control: healthy volunteer age 18-50 years old

Exclusion Criteria:

Chronic illness such as cardiovascular diseases, liver diseases
History of anaphylaxis
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Allergy Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Punchama Pacharn, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj Hospital		Bangkoknoi	Bangkok	10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015151	Immunoblotting

Ancestor Terms

ID	Term
D007118	Immunoassay
D007158	Immunologic Techniques
D008919	Investigative Techniques
D015336	Molecular Probe Techniques

Browse Leaves

Not provided

Browse Branches

Not provided