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Prospective observational study for comparison of clinical efficacy and safety between combination pharmacotherapy of oral antihistamine + leukotriene modifier and mono-pharmacotherapy of intranasal corticosteroid in allergic rhinitis

Prospective observational study for comparison of clinical efficacy and safety between oral antihistamine + leukotriene modifier combination therapy and intranasal corticosteroid monotherapy in allergic rhinitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0012401
Enrollment
116
Registered
2026-08-05
Start date
2025-11-04
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Dankook Univeristy Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients aged =2 years with perennial allergic rhinitis 2) Patients who, according to study enrollment criteria, have taken oral antihistamines for more than 14 days for allergic rhinitis but still have nasal congestion 3) Patients who are able to understand the study and voluntarily consent to participate

Exclusion criteria

Exclusion criteria: 1) Patients with rhinitis symptoms caused by other conditions such as non-allergic rhinitis, nasal polyps, or sinusitis 2) Patients with malignant tumors, autoimmune diseases, or other conditions that would preclude participation in clinical research or significantly affect the study 3) Patients who have adverse reactions to, or for any reason cannot use, the oral antihistamines, leukotriene modifiers, or intranasal corticosteroids used in this study 4) Patients who require medications for allergic rhinitis other than oral antihistamines, leukotriene modifiers, or intranasal corticosteroids during the study period (e.g., antihistamine eye drops, systemic corticosteroids, or decongestants) 5) Patients who require nasal saline irrigation during the study period 6) Patients who have initiated allergen immunotherapy within 12 months prior to enrollment 7) Patients who have received or are scheduled to receive biologics that could affect allergic rhinitis symptoms (anti-IgE mAb, anti-IL5 mAb, anti-IL5R mAb, anti-IL4R mAb, anti-TSLP mAb) within 4 months prior to enrollment 8) Patients who do not consent to participate in the clinical study 9) Women who are pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
Total nasal symptom score

Secondary

MeasureTime frame
Congestion visual analogue scale (Congestion VAS);General rhinitis symptom visual analogue scale (General rhinitis symptom VAS);Total nasal symptom score;Total ocular symptom score;Treatment emergent adverse event;Nighttime nasal symptom score (NNSS)

Countries

Korea, Republic of

Contacts

Public ContactSang Min Lee

Dankook Univeristy Hospital

sangminlee77@naver.com+82-41-550-3893

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Aug 25, 2026