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

NCT05299086 | Completed Phase 3

• 1 other identifier: 059/2565
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Perennial Allergic Rhinitis; Child, Only

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Ocular symptoms score

  8 week

• Peak nasal inspiratory flow (PNIF)

  8 week

• Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)

  8 week

• Medications score Medications score

  8 week

• Nasal FENO (nasal nitric oxide)

  8 week

Study Arms (2)

As needed INCs

PLACEBO COMPARATOR

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)

Regular INCs

ACTIVE COMPARATOR

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)

Interventions

Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray) DRUG

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.

Also known as: As needed Fluticasone furoate nasal spray, Regular Fluticasone furoate nasal spray

As needed INCs; Regular INCs

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

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MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Orathai Piboonpocanun

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: double-blinded placebo controlled randomized controlled trial

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 28, 2022
• Study Start: April 4, 2022
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TH (1)