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 Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||2 Years|
|Official Title:||Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand|
- The recalcitrant symptoms of chronic rhinitis or chronic urticaria [ Time Frame: Baseline and 2 months after treatment ] [ Designated as safety issue: No ]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".
- The correlation between symptom severity and quality of life [ Time Frame: At baseline ] [ Designated as safety issue: No ]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
- Factors affecting therapeutic outcome (composite outcome measure) [ Time Frame: At baseline ] [ Designated as safety issue: No ]Multivariate analysis will be analyzed between age group, gender, allergic status, symptom severity and the magnitude of symptom alteration at 2 months after treatment
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Patients diagnosed with chronic rhinitis or chronic urticaria
Adult patients diagnosed with chronic rhinitis or chronic urticaria and followed-up at Allergy Clinics, King Chulalongkorn Memorial Hospital and Chulalongkorn University Health Service Center
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02000648
|Contact: Jettanong Klaewsongkram, MD||02-2564152||Jettanong.K@chula.ac.th|
|Faculty of Medicine, Chulalongkorn University||Recruiting|
|Bangkok, Thailand, 10330|
|Principal Investigator: Jettanong Klaewsongkram, MD|
|Principal Investigator:||Jettanong Klaewsongkram, MD||Chulalongkorn University|