Clinical trial NCT05299086: As Needed Versus Regular Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis
Official title: As Needed Versus Regular Use of Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perennial Allergic Rhinitis
Child, Only
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded placebo controlled randomized controlled trial
Primary purpose: TREATMENT

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 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: 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 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

Primary outcomes:
measure: TNSS (total nasal symptoms score)
timeFrame: 8 week
measure: VAS score (Visual analog scale score for rhinitis)
timeFrame: 8 week
Secondary outcomes:
measure: Ocular symptoms score
timeFrame: 8 week
measure: Peak nasal inspiratory flow (PNIF)
timeFrame: 8 week
measure: Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)
timeFrame: 8 week
measure: Medications score Medications score
timeFrame: 8 week
measure: Nasal FENO (nasal nitric oxide)
timeFrame: 8 week
measure: Nasal cytology
timeFrame: 8 week
measure: Combined symptom and medication score
timeFrame: 8 week
measure: Correlation VAS versus TNSS, PNIF and RCQ-36
timeFrame: 8 week
measure: Cumulative INCs dose
timeFrame: 8 week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital
name: Orathai Piboonpocanun
role: PRINCIPAL_INVESTIGATOR
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