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

NCT ID: NCT05299086

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2025-04-30

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.

Conditions

Perennial Allergic Rhinitis; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

As needed Fluticasone furoate nasal spray; Regular Fluticasone furoate nasal spray

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

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Orathai Piboonpocanun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Orathai Piboonpocanun

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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

Bangkok, Bangkok, Thailand

Countries

Thailand

References

Tewfik TL, Mazer B. The links between allergy and otitis media with effusion. Curr Opin Otolaryngol Head Neck Surg. 2006 Jun;14(3):187-90. doi: 10.1097/01.moo.0000193190.24849.f0.

Reference Type: BACKGROUND

PMID: 16728898 (View on PubMed)

Lunn M, Craig T. Rhinitis and sleep. Sleep Med Rev. 2011 Oct;15(5):293-9. doi: 10.1016/j.smrv.2010.12.001. Epub 2011 Feb 11.

Reference Type: BACKGROUND

PMID: 21316270 (View on PubMed)

Fokkens W, Lund V, Mullol J; European Position Paper on Rhinosinusitis and Nasal Polyps group. European position paper on rhinosinusitis and nasal polyps 2007. Rhinol Suppl. 2007;20:1-136.

Reference Type: BACKGROUND

PMID: 17844873 (View on PubMed)

Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

Reference Type: BACKGROUND

PMID: 20816182 (View on PubMed)

Brozek 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, Lodrup 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, Roldan 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-Nunez JJ, Zhang L, Zhang Y, Zidarn M, Zuberbier T, Schunemann 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.

Reference Type: BACKGROUND

PMID: 28602936 (View on PubMed)

Bousquet J, Schunemann 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, Bosse 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, Lourenco O, Marien G, Carreiro-Martins P, Melen 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.

Reference Type: BACKGROUND

PMID: 31627910 (View on PubMed)

Skoner DP, Rachelefsky GS, Meltzer EO, Chervinsky P, Morris RM, Seltzer JM, Storms WW, Wood RA. Detection of growth suppression in children during treatment with intranasal beclomethasone dipropionate. Pediatrics. 2000 Feb;105(2):E23. doi: 10.1542/peds.105.2.e23.

Reference Type: BACKGROUND

PMID: 10654983 (View on PubMed)

Lee LA, Sterling R, Maspero J, Clements D, Ellsworth A, Pedersen S. Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis. J Allergy Clin Immunol Pract. 2014 Jul-Aug;2(4):421-7. doi: 10.1016/j.jaip.2014.04.008. Epub 2014 May 21.

Reference Type: BACKGROUND

PMID: 25017530 (View on PubMed)

Skoner DP, Berger WE, Gawchik SM, Akbary A, Qiu C. Intranasal triamcinolone and growth velocity. Pediatrics. 2015 Feb;135(2):e348-56. doi: 10.1542/peds.2014-1641.

Reference Type: BACKGROUND

PMID: 25624374 (View on PubMed)

Juniper EF, Guyatt GH, O'Byrne PM, Viveiros M. Aqueous beclomethasone diproprionate nasal spray: regular versus "as required" use in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 1990 Sep;86(3 Pt 1):380-6. doi: 10.1016/s0091-6749(05)80101-0.

Reference Type: BACKGROUND

PMID: 2212409 (View on PubMed)

Juniper EF, Guyatt GH, Archer B, Ferrie PJ. Aqueous beclomethasone dipropionate in the treatment of ragweed pollen-induced rhinitis: further exploration of "as needed" use. J Allergy Clin Immunol. 1993 Jul;92(1 Pt 1):66-72. doi: 10.1016/0091-6749(93)90039-i.

Reference Type: BACKGROUND

PMID: 8335858 (View on PubMed)

Jen A, Baroody F, de Tineo M, Haney L, Blair C, Naclerio R. As-needed use of fluticasone propionate nasal spray reduces symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol. 2000 Apr;105(4):732-8. doi: 10.1067/mai.2000.105225.

Reference Type: BACKGROUND

PMID: 10756223 (View on PubMed)

Kaszuba SM, Baroody FM, deTineo M, Haney L, Blair C, Naclerio RM. Superiority of an intranasal corticosteroid compared with an oral antihistamine in the as-needed treatment of seasonal allergic rhinitis. Arch Intern Med. 2001 Nov 26;161(21):2581-7. doi: 10.1001/archinte.161.21.2581.

Reference Type: BACKGROUND

PMID: 11718589 (View on PubMed)

Dykewicz MS, Kaiser HB, Nathan RA, Goode-Sellers S, Cook CK, Witham LA, Philpot EE, Rickard K. Fluticasone propionate aqueous nasal spray improves nasal symptoms of seasonal allergic rhinitis when used as needed (prn). Ann Allergy Asthma Immunol. 2003 Jul;91(1):44-8. doi: 10.1016/S1081-1206(10)62057-1.

Reference Type: BACKGROUND

PMID: 12877448 (View on PubMed)

Wartna JB, Bohnen AM, Elshout G, Pijnenburg MW, Pols DH, Gerth van Wijk RR, Bindels PJ. Symptomatic treatment of pollen-related allergic rhinoconjunctivitis in children: randomized controlled trial. Allergy. 2017 Apr;72(4):636-644. doi: 10.1111/all.13056. Epub 2016 Oct 28.

Reference Type: BACKGROUND

PMID: 27696447 (View on PubMed)

Thongngarm T, Wongsa C, Phinyo P, Assanasen P, Tantilipikorn P, Sompornrattanaphan M. As-Needed Versus Regular Use of Fluticasone Furoate Nasal Spray in Patients with Moderate to Severe, Persistent, Perennial Allergic Rhinitis: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1365-1373.e6. doi: 10.1016/j.jaip.2020.09.057. Epub 2020 Oct 10.

Reference Type: BACKGROUND

PMID: 33049392 (View on PubMed)

Bunnag C, Leurmarnkul W, Jareoncharsri P, Ungkanont K, Tunsuriyawong P, Kosrirukvongs P, Sriussadaporn P, Musiksukont S, Kosawanon S, Chairojkanjana K. Development of a health-related quality of life questionnaire for Thai patients with rhinoconjunctivitis. Asian Pac J Allergy Immunol. 2004 Jun-Sep;22(2-3):69-79.

Reference Type: BACKGROUND

PMID: 15565942 (View on PubMed)

Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mosges R, Papadopoulos NG, Rak S, Rodriguez del Rio P, Valovirta E, Wahn U, Calderon MA; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014 Jul;69(7):854-67. doi: 10.1111/all.12383. Epub 2014 Apr 25.

Reference Type: BACKGROUND

PMID: 24761804 (View on PubMed)

Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.

Reference Type: BACKGROUND

PMID: 28217433 (View on PubMed)

Aneeza WH, Husain S, Rahman RA, Van Dort D, Abdullah A, Gendeh BS. Efficacy of mometasone furoate and fluticasone furoate on persistent allergic rhinoconjunctivitis. Allergy Rhinol (Providence). 2013 Fall;4(3):e120-6. doi: 10.2500/ar.2013.4.0065.

Reference Type: BACKGROUND

PMID: 24498516 (View on PubMed)

Jirapongsananuruk O, Vichyanond P. Nasal cytology in the diagnosis of allergic rhinitis in children. Ann Allergy Asthma Immunol. 1998 Feb;80(2):165-70. doi: 10.1016/S1081-1206(10)62950-X.

Reference Type: BACKGROUND

PMID: 9494449 (View on PubMed)

Bjorksten B, Clayton T, Ellwood P, Stewart A, Strachan D; ISAAC Phase III Study Group. Worldwide time trends for symptoms of rhinitis and conjunctivitis: Phase III of the International Study of Asthma and Allergies in Childhood. Pediatr Allergy Immunol. 2008 Mar;19(2):110-24. doi: 10.1111/j.1399-3038.2007.00601.x. Epub 2007 Jul 25.

Reference Type: RESULT

PMID: 17651373 (View on PubMed)

Chinratanapisit S, Suratannon N, Pacharn P, Sritipsukho P, Vichyanond P. Prevalence and risk factors of allergic rhinitis in children in Bangkok area. Asian Pac J Allergy Immunol. 2019 Dec;37(4):232-239. doi: 10.12932/AP-120618-0337.

Reference Type: RESULT

PMID: 30525743 (View on PubMed)

Katelaris CH, Lee BW, Potter PC, Maspero JF, Cingi C, Lopatin A, Saffer M, Xu G, Walters RD. Prevalence and diversity of allergic rhinitis in regions of the world beyond Europe and North America. Clin Exp Allergy. 2012 Feb;42(2):186-207. doi: 10.1111/j.1365-2222.2011.03891.x. Epub 2011 Nov 3.

Reference Type: RESULT

PMID: 22092947 (View on PubMed)

Other Identifiers

059/2565

Identifier Type: -

Identifier Source: org_study_id