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

October 17, 2023 updated by: Orathai Piboonpocanun, Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
          • Orathai Piboonpocanun, Assoc.Prof.
          • Phone Number: 5942 662-419-7000
          • Email: jirapongo@yahoo.com
        • Principal Investigator:
          • Orathai Piboonpocanun, Assoc.Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: As needed INCs

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)
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.
Other Names:
  • As needed Fluticasone furoate nasal spray
  • Regular Fluticasone furoate nasal spray
Active Comparator: Regular INCs

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)
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.
Other Names:
  • As needed Fluticasone furoate nasal spray
  • Regular Fluticasone furoate nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNSS (total nasal symptoms score)
Time Frame: 8 week
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)
Time Frame: 8 week
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
Time Frame: 8 week
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)
Time Frame: 8 week
Change in peak nasal inspiratory flow (PNIF)
8 week
Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)
Time Frame: 8 week
Change in rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)
8 week
Medications score Medications score
Time Frame: 8 week
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)
Time Frame: 8 week
Change in nasal FENO
8 week
Nasal cytology
Time Frame: 8 week

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
Time Frame: 8 week

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
Time Frame: 8 week
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
Time Frame: 8 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Orathai Piboonpocanun, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 059/2565

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perennial Allergic Rhinitis

Clinical Trials on Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe