Status:
COMPLETED
As Needed Versus Regular Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis
Lead Sponsor:
Mahidol University
Conditions:
Perennial Allergic Rhinitis
Child, Only
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
Allergic rhinitis in children is common. According to the international study of asthma and allergies in childhood (ISAAC) phase III, the global prevalence of allergic rhinitis among children is incre...
Detailed Description
8 week Double-blinded placebo controlled randomized controlled trial to compare the efficacy between as-needed and regular use of INCS in children with perennial allergic rhinitis.
Eligibility Criteria
Inclusion
- Children patient (age 6 - 18 yr)
- Mild persistent, Moderate to severe intermittent and persistent perennial allergic rhinitis
- Rhinitis proven sensitization to aeroallergen by positive skin prick test or specific IgE result within 12 month before study recruitment
- Mean TNSS = 4 during 7 day duration before randomization (after a washout period, discontinuation of the medications listed in exclusion criteria
Exclusion
- Patients with rhinosinusitis, nasal polyps, or significant deviated nasal septum
- Patients with a history of uncontrolled asthma, chronic lung disease, cardiovascular, hepatic, or renal diseases
- Patients taking oral or nasal decongestants within 7 d
- Patients taking INCS within 4 week
- Patients taking systemic corticosteroid within 8 week
- Patients taking H1 antihistamine within 1 week
- Patients taking antileukotriene within 4 week
- Patients who were currently or previously treated with allergen immunotherapy
- Patients with a history of upper respiratory tract infection within 14 d
- Patients with primary and secondary immune deficiency
Key Trial Info
Start Date :
April 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05299086
Start Date
April 4 2022
End Date
April 30 2025
Last Update
November 18 2025
Active Locations (1)
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1
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, Thailand, 10700