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Completed

NCT Number: NCT02000648

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

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Key information

Conditions

Allergic Rhinitis Chronic Disease Chronic Urticaria Common Cold Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Non-allergic Rhinitis Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Picornaviridae Infections RNA Virus Infections Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Virus Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The recalcitrant symptoms of chronic rhinitis or chronic urticaria

    Time frame: 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 outcomes

  1. The correlation between symptom severity and quality of life

    Time frame: 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 outcomes

  1. Factors affecting therapeutic outcome (composite outcome measure)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2013
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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