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

Last updated: January 23, 2023
Sponsor: Gachon University Gil Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Common Cold

Allergy

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT05708157
GCIRB2022-327
  • Ages > 19
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Perinnial allergic rhinitis diagnosed by a doctor
  • Positive for one or more of inhalant perinneal allergen in skin prick test or serumspecific IgE measurement
  • Age: 19 years or older
  • Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasalcorticosteroid

Exclusion

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 disorderswhich investigators judge to affect on the study significantly.
  • Patients' rejection
  • Pregenancy or lactation

Study Design

Total Participants: 240
Study Start date:
January 17, 2023
Estimated Completion Date:
February 29, 2024

Study 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.

Connect with a study center

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

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