Clinical trial NCT05708157: Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis
Official title: Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Hallym University Kangnam Sacred Heart Hospital
name: Gangneung Asan Hospital
name: Bundang Jesaeng Hospital
name: Chung-Ang University Gwangmyeong Hospital
name: Hallym University Medical Center
First posted: 2023-02-01
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with perennial allergic rhinitis whose symptoms are not controlled by 2-week treatement with intranasal corticosteroid.

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.

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

Primary outcomes:
measure: TNSS
timeFrame: 2 week
Secondary outcomes:
measure: TOSS
timeFrame: 2 week
measure: RQLQ
timeFrame: 2 week
measure: VAS
timeFrame: 2 week
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Sang Min Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim M, Ryu G, Kang SY, Kim MA, Yang SI, Lee IH, Choi GS, Kim HJ, Lee SM, Kim DK, Choi JH, Yang HJ, Kim SW; Work Group for Rhinitis, the Korean Academy of Asthma, Allergy and Clinical Immunology. Intranasal antihistamine and corticosteroid to treat allergic rhinitis: A systematic review and meta-analysis. Allergy. 2022 Nov;77(11):3436-3440. doi: 10.1111/all.15415. Epub 2022 Jul 8. No abstract available.