Clinical trial

Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid

Name
GCIRB2022-327
Description
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \[VAS\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. After 2-week treatment, changes in clinical parameters including VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be evaluated.
Trial arms
Trial start
2023-01-17
Estimated PCD
2024-02-29
Trial end
2024-02-29
Status
Recruiting
Treatment
concomitant intranasal antihistamine and corticosteroid
concomitant intranasal administration with antihistamine and corticosteroid
Arms:
Active group
Size
240
Primary endpoint
TNSS
2 week
Eligibility criteria
Inclusion Criteria: * Perinnial allergic rhinitis diagnosed by a doctor * Positive for one or more of inhalant perinneal allergen in skin prick test or serum specific IgE measurement * Age: 19 years or older * Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasal corticosteroid Exclusion Criteria: * Compliance for one or more drugs in last 2 weeks: \<80% * Use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks * Initiation of allergen-specific immunotherapy in last 12 months * Seasonal allergic rhinitis * Chronic rhinosinusitis other than allergic rhinitis * Nasal polyposis * Comorbid diseases including infectious, respiratory, cardiologic, renal, gastrointestinal, endocrinologic, oncologic, hemotologic and immunologic disorders which investigators judge to affect on the study significantly. * Patients' rejection * Pregenancy or lactation
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}
Updated at
2023-02-01

1 organization

1 product

1 indication