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

NCT ID: NCT05708157

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-17

Study Completion Date

2024-02-29

Brief Summary

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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

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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.

Conditions

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Allergic Rhinitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Active group

Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.

concomitant intranasal antihistamine and corticosteroid

Intervention Type DRUG

concomitant intranasal administration with antihistamine and corticosteroid

Interventions

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concomitant intranasal antihistamine and corticosteroid

concomitant intranasal administration with antihistamine and corticosteroid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Gangneung Asan Hospital

OTHER

Sponsor Role collaborator

Bundang Jesaeng Hospital

UNKNOWN

Sponsor Role collaborator

Chung-Ang University Gwangmyeong Hospital

OTHER

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role collaborator

Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sangmin Lee, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Min Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

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Gachon University Gil Medical Center

Incheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang Min Lee, MD, PhD

Role: CONTACT

82324582713

Facility Contacts

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Sang Min Lee, MD, PhD

Role: primary

82324582713

References

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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.

Reference Type BACKGROUND
PMID: 35716356 (View on PubMed)

Other Identifiers

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GCIRB2022-327

Identifier Type: -

Identifier Source: org_study_id

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