As Needed Versus Regular Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis

Study Overview
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Brief Summary
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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 increasing to 40.1% and the prevalence of allergic rhinitis in Bangkok area in 2018, among children aged 6-7 and 13-14 years was 16.32%. This disease is a global health problem affecting quality of life of patients in daily life, work, study and sleep. Intranasal corticosteroid is the most effective treatment for allergic rhinitis. From real world evidence; most of allergic rhinitis patient use the drug when symptoms worsen. In children, the use of intranasal corticosteroid may cause minor local side effects such as dryness, burning sensation or epistaxis. In some intranasal corticosteroid, long-term use may result in decreased growth compared to placebo which make parents concern. The investigators interested in studying the efficacy of intranasal corticosteroid comparing between daily use and as needed use in children with allergic rhinitis. To study the appropriate form of treatment to increase cooperation. Patient will have a better quality of life and reduce the risk of side effects from prolonged use of intranasal corticosteroid. From the literature review, it was found that most studies were conducted among adult patients with seasonal allergic rhinitis In Thailand in 2020, Thongngam et al. studied the efficacy of intranasal corticosteroid was compared between daily use and as needed use in adult patients with perennial allergic rhinitis. The results of the study concluded that the daily use group can reduced more TNSS (total nasal symptoms score) but was not statistically significant and had a greater increase in peak nasal inspiratory flow (PNIF) compared to as needed group. Interestingly, the quality of life assessment (RCQ-36 score) in both2 groups improved equally, In as needed group, the cumulative dose was 51% lower than the daily dose group. The investigators want to compare the efficacy of intranasal corticosteroid between daily versus as needed use in children with perennial allergic rhinitis which had not been studied before.

Detailed Description
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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.

Official Title
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As Needed Versus Regular Use of Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis: A Randomized Controlled Trial

Conditions
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Perennial Allergic Rhinitis, Child, Only

Intervention / Treatment
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* Drug: Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double-blinded placebo controlled randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: As needed INCs<br>Use placebo everyday, and INCs as needed when the nasal symptom aggravated INCs = Fluticasone furoate nasal spray Placebo = Normal saline nasal spray Doses Fluticasone furoate nasal spray (27.5 mg/spray) age<12 yr:1 spray once daily 12 yr and older: 2 sprays once daily Normal saline nasal spray age<12 yr:1 spray once daily 12 yr and older: 2 sprays once daily | Drug: Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray)<br>* The investigators want to compare the efficacy of intranasal corticosteroid between daily versus as needed use in children with perennial allergic rhinitis which had not been studied before.<br>* Other names: Regular Fluticasone furoate nasal spray;|
| Active Comparator: Regular INCs<br>Use INCs everyday, and placebo as needed when the nasal symptom aggravated INCs = Fluticasone furoate nasal spray Placebo = Normal saline nasal spray Doses Fluticasone furoate nasal spray (27.5 mg/spray) age<12 yr:1 spray once daily 12 yr and older: 2 sprays once daily Normal saline nasal spray age<12 yr:1 spray once daily 12 yr and older: 2 sprays once daily | Drug: Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray)<br>* The investigators want to compare the efficacy of intranasal corticosteroid between daily versus as needed use in children with perennial allergic rhinitis which had not been studied before.<br>* Other names: Regular Fluticasone furoate nasal spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNSS (total nasal symptoms score) | change in TNSS 4 nose symptoms (sneezing, itching nose, watery running nose and blockage) The minimum score is 0 and maximum score is 3 each symptoms (__/12) higher scores mean worse outcome. | 8 week | 
| VAS score (Visual analog scale score for rhinitis) | change in VAS score Score is 0 - 10 mm higher scores mean worse outcome. | 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular symptoms score | Change in ocular symptoms score 2 eye symptoms (tearing eyes, itching eyes/red eyes) The minimum score is 0 and maximum score is 3 each symptoms (__/6) Higher scores mean worse outcome. | 8 week | 
| Peak nasal inspiratory flow (PNIF) | Change in peak nasal inspiratory flow (PNIF) | 8 week | 
| Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36) | Change in rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36) | 8 week | 
| Medications score Medications score | Change in medications score Medication score Oral and/or topical (eyes or nose) non-sedative H1 antihistamines (H1A)=1 Intranasal corticosteroids (INS) with/without H1A =2 Oral corticosteroids with/without INS, with/without H1A =3 Total daily medication score (dMS) 0-3 Higher scores mean worse outcome. | 8 week | 
| Nasal FENO (nasal nitric oxide) | Change in nasal FENO | 8 week | 
| Nasal cytology | Change in nasal cytology Grading Nasal Cytograms A. Epithelial cells Normal morphology N Abnormal morphology A Ciliocytophthoria CCP B. Eosinophils, neutrophils 0* None 0 0.1-1.0* ½+ 1.1-5.0* 1+ 6.0-15.0* 2+ 16.0-20.0* 3+ >20.0* 4+ C. Basophilic cells 0 None 0 0.1-0.3* ½+ 0.4-1.0* 1+ 1.1-3.0* 2+ 3.1-6.0* 3+ >6.0* 4+ D. Bacteria N/A+ None 0 N/A+ 1+ N/A+ 2+ N/A+ 3+ N/A+ 4+ E. Goblet cells# 0-24% 1+ 25-49% 2+ 50-74% 3+ 75-100% 4+ Mean of cells per 10 high power fields (x1000). + Note presence of intracellular bacteria. # Ratio of goblet cells to epithelial cells, expressed as percent. | 8 week | 
| Combined symptom and medication score | Change in combined symptom and medication score Cumulative of (nasal symptoms score + ocular symptoms score)/3 and medication score The minimum score is 0 maximum score is 6, (__/6) Higher scores mean worse outcome. Pfaar et al., EAACI Position Paper: 'clinical outcomes used in allergen immunotherapy trials, Allergy 69 (2014) 854-867 | 8 week | 
| Correlation VAS versus TNSS, PNIF and RCQ-36 | VAS score (Visual analog scale score for rhinitis) total nasal symptoms score Peak nasal inspiratory flow (PNIF) Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36) | 8 week | 
| Cumulative INCs dose | weight the nasal spray bottles (both Fluticasone furoate nasal spray and normal saline nasal spray) on digital scale each visit and record to compare INCS used in each group | 8 week |