ClinicalTrials.gg
Status unknownNCT05708157INCS/INAHUpdated Feb 1, 2023

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

An observational study in Allergic Rhinitis, sponsored by Gachon University Gil Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Gachon University Gil Medical Center · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
240
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Allergic Rhinitis

Browse trials for

03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 240 is above the median of 120 across 143 observational studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Gachon University Gil Medical Center is the lead sponsor of 90 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Compliance for one or more drugs in last 2 weeks: \<80%
  • Use of oral , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • Active group

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

    Drug: concomitant intranasal antihistamine and corticosteroid

Interventions

  • Drugconcomitant intranasal antihistamine and corticosteroid

    concomitant intranasal administration with antihistamine and corticosteroid

06

What researchers measure

Primary outcomes

  1. TNSS

    total nasal symptom score

    Time frame: 2 week

Secondary outcomes

  1. TOSS

    total nasal symptom score

    Time frame: 2 week

  2. RQLQ

    rhinoconjunctivitis quality-of-life questionnares

    Time frame: 2 week

  3. VAS

    visual analogue scale

    Time frame: 2 week

07

Study locations

1 of 1 sites recruiting
  • Gachon University Gil Medical Center
    Incheon, 21565, Korea, Republic of
    Recruiting
    • Sang Min Lee, MD, PhD · Contactsangminlee77@naver.com · 82324582713
    • Sang Min Lee, MD, PhD · Principal investigator
08

References and documents

Publications

  • 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. PubMed 35716356 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05708157
Lead sponsor
Gachon University Gil Medical Center
Collaborators
Hallym University Kangnam Sacred Heart Hospital, Gangneung Asan Hospital, Bundang Jesaeng Hospital, Chung-Ang University Gwangmyeong Hospital, Hallym University Medical Center
Responsible party
Sangmin Lee, MD (Professor, Gachon University Gil Medical Center) — Principal investigator
First posted
Feb 1, 2023
Start date
Jan 17, 2023
Primary completion
Feb 29, 2024 (estimated)
Completion
Feb 29, 2024 (estimated)
Last update
Feb 1, 2023

Study contacts

Sang Min Lee, MD, PhD
Contact
sangminlee77@naver.com
82324582713
Sang Min Lee, MD, PhD
principal investigator · Gachon University Gil Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion