Comparing as-needed versus regular use of nasal corticosteroids in children with allergic rhinitis
As Needed Versus Regular Use of Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis: A Randomized Controlled Trial
This study is testing whether using nasal sprays for allergies only when needed works as well as using them every day for kids aged 6 to 18.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT05299086 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intranasal corticosteroids (INCS) in children with perennial allergic rhinitis by comparing two treatment approaches: as-needed use versus regular daily use. The study is designed as an 8-week double-blinded, placebo-controlled randomized trial, where participants will receive either Fluticasone furoate nasal spray or a placebo. The aim is to determine which method provides better symptom relief while minimizing potential side effects associated with long-term corticosteroid use. Children aged 6 to 18 years with confirmed allergic rhinitis will be recruited for this trial.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 18 years with mild to moderate persistent or severe intermittent perennial allergic rhinitis.
Not a fit: Patients with significant nasal conditions, uncontrolled asthma, or those currently on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective and safer treatment strategies for managing allergic rhinitis in children.
How similar studies have performed: Previous studies have shown varying success with intranasal corticosteroids in treating allergic rhinitis, but this specific comparison of treatment approaches is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Bangkok
- Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Orathai Piboonpocanun — Siriraj Hospital
- Study coordinator: Ongon Boonnijasin
- Email: Ongonprojectfellow@gmail.com
- Phone: 0839797522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.