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

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT02000648

Collaborator

(none)

500

Enrollment

Location

Actual Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Non-allergic Rhinitis Chronic Urticaria

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The recalcitrant symptoms of chronic rhinitis or chronic urticaria [Baseline and 2 months after treatment]
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".

Secondary Outcome Measures

The correlation between symptom severity and quality of life [At baseline]
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

Other Outcome Measures

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