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Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis (INCS/INAH)

G

Gachon University Gil Medical Center

Status

Enrolling

Conditions

Allergic Rhinitis

Treatments

Drug: concomitant intranasal antihistamine and corticosteroid

Study type

Observational

Funder types

Other

Identifiers

NCT05708157
GCIRB2022-327

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

240 participants in 1 patient group

Active group
Description:
Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.
Treatment:
Drug: concomitant intranasal antihistamine and corticosteroid

Trial contacts and locations

1

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Central trial contact

Sang Min Lee, MD, PhD

Data sourced from clinicaltrials.gov

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