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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05708157
Acronym
INCS/INAH
Enrollment
240
Registered
2023-02-01
Start date
2023-01-17
Completion date
2024-02-29
Last updated
2023-02-01

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

Conditions

Allergic Rhinitis

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.

Interventions

DRUGconcomitant intranasal antihistamine and corticosteroid

concomitant intranasal administration with antihistamine and corticosteroid

Sponsors

Hallym University Kangnam Sacred Heart Hospital
CollaboratorOTHER
Gangneung Asan Hospital
CollaboratorOTHER
Bundang Jesaeng Hospital
CollaboratorUNKNOWN
Chung-Ang University Gwangmyeong Hospital
CollaboratorOTHER
Hallym University Medical Center
CollaboratorOTHER
Gachon University Gil Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TNSS2 weektotal nasal symptom score

Secondary

MeasureTime frameDescription
RQLQ2 weekrhinoconjunctivitis quality-of-life questionnares
VAS2 weekvisual analogue scale
TOSS2 weektotal nasal symptom score

Countries

South Korea

Contacts

Primary ContactSang Min Lee, MD, PhD
sangminlee77@naver.com82324582713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026