NCT05708157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

January 23, 2023

Last Update Submit

January 23, 2023

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • TNSS

    total nasal symptom score

    2 week

Secondary Outcomes (3)

  • TOSS

    2 week

  • RQLQ

    2 week

  • VAS

    2 week

Study Arms (1)

Active group

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

Drug: concomitant intranasal antihistamine and corticosteroid

Interventions

concomitant intranasal antihistamine and corticosteroidDRUG

concomitant intranasal administration with antihistamine and corticosteroid

Active group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with perennial allergic rhinitis whose symptoms are not controlled by 2-week treatement with intranasal corticosteroid.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 21565, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35716356BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Sang Min Lee, MD, PhD

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Min Lee, MD, PhD

CONTACT

82324582713sangminlee77@naver.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 1, 2023

Study Start

January 17, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)