Clinical trial NCT02000648: Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand
Official title: Real-life Management and Therapeutic Outcome of Patients With Chronic Rhinitis and Chronic Urticaria in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Non-allergic Rhinitis
Chronic Urticaria
Keywords: Allergic Rhinitis
Non-allergic Rhinitis
Chronic urticaria
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic rhinitis or chronic urticaria

Brief summary: Observation study of patients with chronic rhinitis or chronic urticaria in Thailand

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.

Eligibility criteria: 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

Primary outcomes:
measure: The recalcitrant symptoms of chronic rhinitis or chronic urticaria
timeFrame: Baseline and 2 months after treatment
Secondary outcomes:
measure: The correlation between symptom severity and quality of life
timeFrame: At baseline
Other outcomes:
measure: Factors affecting therapeutic outcome (composite outcome measure)
timeFrame: At baseline
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.