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

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ClinicalTrials.gov Identifier: NCT05299086
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : September 13, 2022
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.


Condition or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Child, Only Drug: Intranasal Drug (INCS = Fluticasone furoate nasal spray, Placebo = Normal saline nasal spray) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded placebo controlled randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: As Needed Versus Regular Use of Intranasal Corticosteroid in Children With Perennial Allergic Rhinitis: A Randomized Controlled Trial
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Peak nasal inspiratory flow (PNIF) [ Time Frame: 8 week ]
    Change in peak nasal inspiratory flow (PNIF)

  3. Rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36) [ Time Frame: 8 week ]
    Change in rhinoconjunctivitis Quality of Life-36 Questionnaire score (RCQ-36)

  4. 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.

  5. Nasal FENO (nasal nitric oxide) [ Time Frame: 8 week ]
    Change in nasal FENO

  6. 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.

  7. 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. 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)

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05299086


Contacts
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Contact: Ongon Boonnijasin 0839797522 Ongonprojectfellow@gmail.com
Contact: Orathai Piboonpocanun, Professor +66815818803 jirapongo@yahoo.com

Locations
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Thailand
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Orathai Piboonpocanun, Assoc.Prof.    662-419-7000 ext 5942    jirapongo@yahoo.com   
Principal Investigator: Orathai Piboonpocanun, Assoc.Prof.         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Orathai Piboonpocanun Siriraj Hospital
Publications of Results:
Other Publications:
Brożek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, Brignardello-Petersen R, Canonica GW, Casale T, Chavannes NH, Correia de Sousa J, Cruz AA, Cuello-Garcia CA, Demoly P, Dykewicz M, Etxeandia-Ikobaltzeta I, Florez ID, Fokkens W, Fonseca J, Hellings PW, Klimek L, Kowalski S, Kuna P, Laisaar KT, Larenas-Linnemann DE, Lødrup Carlsen KC, Manning PJ, Meltzer E, Mullol J, Muraro A, O'Hehir R, Ohta K, Panzner P, Papadopoulos N, Park HS, Passalacqua G, Pawankar R, Price D, Riva JJ, Roldán Y, Ryan D, Sadeghirad B, Samolinski B, Schmid-Grendelmeier P, Sheikh A, Togias A, Valero A, Valiulis A, Valovirta E, Ventresca M, Wallace D, Waserman S, Wickman M, Wiercioch W, Yepes-Nuñez JJ, Zhang L, Zhang Y, Zidarn M, Zuberbier T, Schünemann HJ. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017 Oct;140(4):950-958. doi: 10.1016/j.jaci.2017.03.050. Epub 2017 Jun 8.
Bousquet J, Schünemann HJ, Togias A, Bachert C, Erhola M, Hellings PW, Klimek L, Pfaar O, Wallace D, Ansotegui I, Agache I, Bedbrook A, Bergmann KC, Bewick M, Bonniaud P, Bosnic-Anticevich S, Bossé I, Bouchard J, Boulet LP, Brozek J, Brusselle G, Calderon MA, Canonica WG, Caraballo L, Cardona V, Casale T, Cecchi L, Chu DK, Costa EM, Cruz AA, Czarlewski W, D'Amato G, Devillier P, Dykewicz M, Ebisawa M, Fauquert JL, Fokkens WJ, Fonseca JA, Fontaine JF, Gemicioglu B, van Wijk RG, Haahtela T, Halken S, Ierodiakonou D, Iinuma T, Ivancevich JC, Jutel M, Kaidashev I, Khaitov M, Kalayci O, Kleine Tebbe J, Kowalski ML, Kuna P, Kvedariene V, La Grutta S, Larenas-Linnemann D, Lau S, Laune D, Le L, Lieberman P, Lodrup Carlsen KC, Lourenço O, Marien G, Carreiro-Martins P, Melén E, Menditto E, Neffen H, Mercier G, Mosgues R, Mullol J, Muraro A, Namazova L, Novellino E, O'Hehir R, Okamoto Y, Ohta K, Park HS, Panzner P, Passalacqua G, Pham-Thi N, Price D, Roberts G, Roche N, Rolland C, Rosario N, Ryan D, Samolinski B, Sanchez-Borges M, Scadding GK, Shamji MH, Sheikh A, Bom AT, Toppila-Salmi S, Tsiligianni I, Valentin-Rostan M, Valiulis A, Valovirta E, Ventura MT, Walker S, Waserman S, Yorgancioglu A, Zuberbier T; Allergic Rhinitis and Its Impact on Asthma Working Group. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 2020 Jan;145(1):70-80.e3. doi: 10.1016/j.jaci.2019.06.049. Epub 2019 Oct 15. Review. Erratum in: J Allergy Clin Immunol. 2022 Jun;149(6):2180.

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT05299086    
Other Study ID Numbers: 059/2565
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: September 13, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Xhance
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents