Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Chronic Urticaria; Non-allergic Rhinitis

Detailed Description

All patients presenting with symptoms of chronic rhinitis for at least 12 consecutive or non-consecutive weeks per years or symptoms of chronic urticaria for at least 6 weeks will be asked to complete the case report forms asking for details of symptom characteristics, risk factors, personal habits, underlying diseases, and quality of life at the first visit. Investigation results, final diagnosis, and therapeutic interventions will also be recorded by the responsible allergist. On every follow-up appointment, patient symptoms, aggravating factors, medication use and side effects will be completed by patients. New findings, associated diseases, and prescriptions will be completed by allergist. The unfilled variables by patients will be asked in the following visit. Any "non-reported" variables those are unable to retrieve will be treated as missing data for data analysis. The estimated sample size is about 200 new cases per year.

Patient demographic data, clinical presentations, and associated diseases will be reported. The association between clinical characteristics and quality of life will be analyzed. The relationship between clinical manifestations and therapeutic outcomes will be determined.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic rhinitis or chronic urticaria

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Less than 15 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between symptom severity and quality of life	Pearson correlation between total nasal symptom score in patients with rhinitis or urticaria activity score in patients with chronic urticaria and 12-item short form survey version 2 (SF-12 v2) will be analyzed	At baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors affecting therapeutic outcome (composite outcome measure)	Multivariate analysis will be analyzed between age group, gender, allergic status, symptom severity and the magnitude of symptom alteration at 2 months after treatment	At baseline

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Extranasal symptoms of allergic rhinitis are difficult to treat and affect quality of life

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 24, 2013
• First Submitted That Met QC Criteria: December 3, 2013
• First Posted (Estimate): December 4, 2013

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Chronic urticaria; Non-allergic Rhinitis
• Additional Relevant MeSH Terms: Skin Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Skin Diseases, Vascular; Picornaviridae Infections; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Common Cold; Urticaria; Chronic Urticaria
• Other Study ID Numbers: Chula-ARC 001/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO