Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis

Recruiting

• Conditions: Allergic Rhinitis
• Interventions: Drug: concomitant intranasal antihistamine and corticosteroid

• Registration Number: NCT05708157
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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.

Detailed 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. In addition to VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be measured before treatment (baseline) and 2 week after treatment. The differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p\<0.05 was considered statistically significant.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-17
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Study First Posted: 2023-02-01
• Last Update Posted: 2023-02-01
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active group	concomitant intranasal antihistamine and corticosteroid	Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.

Primary Outcome Measures

Name	Time	Method
TNSS	2 week	total nasal symptom score

Secondary Outcome Measures

Name	Time	Method
VAS	2 week	visual analogue scale
TOSS	2 week	total nasal symptom score
RQLQ	2 week	rhinoconjunctivitis quality-of-life questionnares

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of