NCT02000648

Brief Summary

Observation study of patients with chronic rhinitis or chronic urticaria in Thailand

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

3.1 years

First QC Date

November 24, 2013

Last Update Submit

February 15, 2019

Conditions

Keywords

Allergic RhinitisNon-allergic RhinitisChronic urticaria

Outcome Measures

Primary Outcomes (1)

  • The recalcitrant symptoms of chronic rhinitis or chronic urticaria

    The alteration of symptoms at 2 months compared to baseline. Patient's complaining symptoms will be graded as likert scale system (0, 1, 2, 3). Any symptoms at 2 months after treatment that decrease less than 25% from base line based on average likert scale will be defined as "recalcitrant".

    Baseline and 2 months after treatment

Secondary Outcomes (1)

  • The correlation between symptom severity and quality of life

    At baseline

Other Outcomes (1)

  • Factors affecting therapeutic outcome (composite outcome measure)

    At baseline

Study Arms (1)

Patients diagnosed with chronic rhinitis or chronic urticaria

Patients diagnosed with chronic rhinitis/urticaria and followed-up at Allergy Clinics, Chulalongkorn University

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic rhinitis or chronic urticaria

You may qualify if:

  • Have symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per year or symptoms of chronic urticaria for at least 6 weeks

You may not qualify if:

  • Less than 15 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Jaruvongvanich V, Mongkolpathumrat P, Chantaphakul H, Klaewsongkram J. Extranasal symptoms of allergic rhinitis are difficult to treat and affect quality of life. Allergol Int. 2016 Apr;65(2):199-203. doi: 10.1016/j.alit.2015.11.006. Epub 2016 Jan 19.

Related Links

MeSH Terms

Conditions

Rhinitis, AllergicCommon ColdChronic Urticaria

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jettanong Klaewsongkram, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Jettanong Klaewsongkram, MD.

Study Record Dates

First Submitted

November 24, 2013

First Posted

December 4, 2013

Study Start

January 1, 2012

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations