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

Primary Purpose

Perennial Allergic Rhinitis, Child, Only

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

As needed INCs

Regular INCs

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
VAS score (Visual analog scale score for rhinitis)
change in VAS score Score is 0 - 10 mm higher scores mean worse outcome.

Secondary Outcome Measures

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.
Peak nasal inspiratory flow (PNIF)
Change in peak nasal inspiratory flow (PNIF)
Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)
Change in rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)
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.
Nasal FENO (nasal nitric oxide)
Change in nasal FENO
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.
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
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)
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

Full Information

First Posted
March 8, 2022
Last Updated
October 17, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05299086
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis, Child, Only

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double-blinded placebo controlled randomized controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
As needed INCs
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Regular INCs
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray)
Other Intervention Name(s)
As needed Fluticasone furoate nasal spray, Regular Fluticasone furoate nasal spray
Intervention Description
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.
Primary Outcome Measure Information:
Title
TNSS (total nasal symptoms score)
Description
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.
Time Frame
8 week
Title
VAS score (Visual analog scale score for rhinitis)
Description
change in VAS score Score is 0 - 10 mm higher scores mean worse outcome.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Ocular symptoms score
Description
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.
Time Frame
8 week
Title
Peak nasal inspiratory flow (PNIF)
Description
Change in peak nasal inspiratory flow (PNIF)
Time Frame
8 week
Title
Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)
Description
Change in rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)
Time Frame
8 week
Title
Medications score Medications score
Description
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.
Time Frame
8 week
Title
Nasal FENO (nasal nitric oxide)
Description
Change in nasal FENO
Time Frame
8 week
Title
Nasal cytology
Description
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.
Time Frame
8 week
Title
Combined symptom and medication score
Description
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
Time Frame
8 week
Title
Correlation VAS versus TNSS, PNIF and RCQ-36
Description
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)
Time Frame
8 week
Title
Cumulative INCs dose
Description
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
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ongon Boonnijasin
Phone
0839797522
Email
Ongonprojectfellow@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Orathai Piboonpocanun, Professor
Phone
+66815818803
Email
jirapongo@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orathai Piboonpocanun
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orathai Piboonpocanun, Assoc.Prof.
Phone
662-419-7000
Ext
5942
Email
jirapongo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Orathai Piboonpocanun, Assoc.Prof.

12. IPD Sharing Statement

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

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