Comparing Budesonide and Fluticasone Propionate in Children with Moderate to Severe Asthma: A Pilot Randomized Controlled Trial
-
Mansour Sadeghzadeh
,
Parisa Khoshnevisasl
,
Akefeh Ahmadiafshar
,
Nima Motamed
,
Azadeh Pourmarjani
Abstract
The aim of asthma treatment is to reduce airway inflammation by avoiding environmental triggers and using daily anti-inflammatory medications. This study aimed to compare the effects of fluticasone propionate (FP) and budesonide (Bud) on the clinical symptoms and control of asthma in children with moderate to severe asthma.
In this open-label study, children with moderate to severe asthma were randomly selected to receive either FP 250 mcg or Bud 400 mcg for 3 months. Asthma control test scores were measured in both groups monthly. The clinical symptoms, drug adherence, and rescue medication were also evaluated.
A total of 50 patients with ages between 4 and 7 years old were included in the study (25 cases received Bud and 25 cases received FP). Asthma control test scores, daily and nocturnal symptoms, and cough rates were significantly improved in both groups. The average asthma control scores for the fluticasone group were 21.68±3.32 in the second month and 24.84±2.67 in the third month, whereas the budesonide group had scores of 18.52±3.32 and 22.48±4.12 during the same periods. These variances were statistically significant. Additionally, the requirement for salbutamol use was notably reduced in the fluticasone group compared to the budesonide group throughout all three months.
The efficacy of fluticasone propionate in decreasing the need for rescue medication and enhancing asthma control test scores was markedly superior to that of budesonide.
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15. Von Berg A, Engelstatter R, Minic P, Sreckovic M, Garcia Garcia ML, Latos T,et al. Comparison of the efficacy and safety of ciclesonide 160 microg once daily vs. budesonide 400 microg once daily in children with asthma. Pediatr Allergy Immunol. 2007;18(5):391-400.
16. Karakoç F1, Karadag B, Kut A, Ersu R, Bakaç S, Cebeci D, Dagli E. A comparison of the efficacy and safety of a half dose of fluticasone propionate with beclamethasone dipropionate and budesonide in childhood asthma. J Asthma. 2001;38(3):229-37.
17. Rao MR, Thota RK, Senthi M, Mogadati P, Arutla S. A Mass Compatible Uplc Method For The Quantification Of Impurities In Fluticasone Propionate Nasal Spray. International Journal of Pharmacy and Pharmaceutical Sciences. 2020 Nov 1:80-7. PMID: 32104218 PMCID: PMC7027130 DOI: 10.3892/etm.2019.8401.
18. Lin J, Chen P, Liu C, Kang J, Xiao W, Chen Z, et al. Comparison of fluticasone propionate with budesonide administered via nebulizer: a randomized controlled trial in patients with severe persistent asthma. J Thorac Dis. 2017;9(2):372. PMID: 28275486 PMCID: PMC5334096 DOI: 10.21037/jtd.2017.02.51.
19. Pelaia G, Vatrella A, Busceti MT, Fabiano F, Terracciano R, Matera MG, Maselli R. Molecular and cellular mechanisms underlying the therapeutic effects of budesonide in asthma. Pulm Pharmacol Ther. 2016;40(6):15-21. PMID: 27381656 DOI: 10.1016/j.pupt.2016.07.001.
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21. National Asthma Education and Prevention Program Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007 J Allergy Clin Immunol. 2007;120(5 Suppl):S94-138. PMID: 17983880 DOI: 10.1016/j.jaci.2007.09.043
22. Kaya A, Erkocoglu M, Akan A, Vezir E, Azkur D, Ozcan C, Civelek E, Toyran M, Giniş T, Misirlioglu ED, Kocabas CN. TRACK as a complementary tool to GINA and NAEPP guidelines for assessing asthma control in pre-school children. J Asthma. 2014;51(5):530-5. PMID: 24494666 DOI: 10.3109/02770903.2014.887729.
23.Maisonneuve MH, Grasemann H. Diagnosis and management of preschool asthma. CURR ALLERGY CLIN IM.2018 Jun 1;31(2):80-4.
24. Kuo LY, Hung CH, Tseng HI, Wu JR, Jong YJ, Chu YT. Effects of budesonide and fluticasone propionate in pediatric asthma patients. Pediatr Neonatol. 2010;51(1):31-6.
25. Jenkins C, Woolcock AJ, Saarelainen P, Lundback B, James MH. Salmeterol/fluticasone propionate combination therapy 50/250 μg twice daily is more effective than budesonide 800 μ g twice daily in treating moderate to severe asthma. Respir Med. 2000;94(7):715-23. PMID: 10926345 DOI: 10.1053/rmed.2000.0875.
26. Ahmadiafshar A, Mogimi Hadji M, Rezaei N. Comparison of Effectiveness between Beclomethasone Dipropionate and Fluticasone Propionate in Treatment of Children with Moderate Asthma. World Allergy Organ J .2010;3(12):250–252. PMID: 23282900 PMCID: PMC3651060 DOI: 10.1097/WOX.0b013e3181f68d92
27. Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015;115(6):516-22.
28. Harrison TW, Wisniewski A, Honour J, Tattersfield AE Comparison of the systemic effects of fluticasone propionate and budesonide given by dry powder inhaler in healthy and asthmatic subjects .Thorax. 2001;56(3):186-91.
29. Axelsson I, Naumburg E, Prietsch SO, Zhang L. Inhaled corticosteroids in children with persistent asthma: effects of different drugs and delivery devices on growth. Cochrane Database Syst Rev. 2019;6(6):CD010126. PMID: 31194879 PMCID: PMC6564081 DOI: 10.1002/14651858.CD010126.pub2.
2. Luo G, Nkoy FL, Stone BL, Schmick D, Johnson MD. A systematic review of predictive models for asthma development in children. BMC Med Inform Decis Mak. 2015;15:99. PMID: 26615519 PMCID: PMC4662818 DOI: 10.1186/s12911-015-0224-9
3. Papadopoulos NG, Arakawa H, Carlsen KH, et al. International consensus on (ICON) pediatric asthma. Allergy. 2012;67(8):976-97.
4. Urbano FL. Review of the NAEPP 2007 Expert Panel Report (EPR-3) on Asthma Diagnosis and Treatment Guidelines. J Manag Care Pharm. 2008;14:41–49.
5. Xiaojing Guo, Zhuoying Li, Weijun Ling, Jianxiong Long, Cuilin Su, Jinglin Li, et al. Epidemiology of childhood asthma in mainland China (1988–2014): A meta-analysis. Allergy Asthma Proc. 2018;39(3):e15–29.
6. Lara J Akinbami 1, Jeanne E Moorman, Xiang Liu. Asthma Prevalence, Health Care Use, and Mortality: United States, 2005-2009. Natl Health Stat Report. 2011;(32):1-14.
7. Jang J, Chan KCG, Huang H, Sullivan SD. Trends in cost and outcomes among adult and pediatric patients with asthma 2000-2009. Ann Allergy Asthma Immunol. 2013;111(12):516–22.
8. Bacharier LB, Guilbert TW. New Directions in Pediatric Asthma. Immunol Allergy Clin North Am. 2019;39(2):283-95.
9. Ahmadiafshar A, Ahmadiafshar S. Efficacy and Safety of Inhaled and Intranasal Corticosteroids. Antiinflamm Antiallergy Agents Med Chem. 2014;13(6):83-7. PMID: 25175908 DOI: 10.2174/1871523013666140826115204.
10. Hossny E, Rosario N, Lee Bh, Singh M, El-Ghoneimy D, Soh JY, et al. The use of inhaled corticosteroids in pediatric asthma: update. World Allergy Organ J.2016;9:26 . PMID: 27551328 PMCID: PMC4982274 DOI: 10.1186/s40413-016-0117-0.
11. Gulliver T, Morton R, Eid N. Inhaled corticosteroids in children with asthma: pharmacologic determinants of safety and efficacy and other clinical considerations. Paediatr Drugs. 2007;9(3):185-94. PMID: 17523699 DOI: 10.2165/00148581-200709030-00007.
12. Lin-Yu K, Chih-Hsing H, Hsing-I T, Jiunn-Ren W, Yuh-Jyh J, Yu-Te C. Effects of Budesonide and Fluticasone Propionate in Pediatric Asthma Patients. Pediatr Neonatol 2010;51(1):31−6.
13. Tunceli O, Williams SA, Kern DM, Elhefni H, Pethick N, Wessman C, Zhou S, Trudo F. Comparative effectiveness of budesonide-formoterol combination and fluticasone-salmeterol combination for asthma management: a United States retrospective database analysis. J Allergy Clin Immunol Pract. 2014 Nov-Dec;2(6):719-26. PMID: 25439363.doi: 10.1016/j.jaip.2014.07.016.
14. Wu Z, Bian X, Hui L, Zhang J. Nebulized step‑down budesonide vs. fluticasone in infantile asthma: A retrospective cohort study Corrigendum in/10.3892/etm. 2020.9140. Exp Ther Med. 2020;19(3):1665-72. PMID: 32104218 PMCID: PMC7027130 DOI: 10.3892/etm.2019.8401.
15. Von Berg A, Engelstatter R, Minic P, Sreckovic M, Garcia Garcia ML, Latos T,et al. Comparison of the efficacy and safety of ciclesonide 160 microg once daily vs. budesonide 400 microg once daily in children with asthma. Pediatr Allergy Immunol. 2007;18(5):391-400.
16. Karakoç F1, Karadag B, Kut A, Ersu R, Bakaç S, Cebeci D, Dagli E. A comparison of the efficacy and safety of a half dose of fluticasone propionate with beclamethasone dipropionate and budesonide in childhood asthma. J Asthma. 2001;38(3):229-37.
17. Rao MR, Thota RK, Senthi M, Mogadati P, Arutla S. A Mass Compatible Uplc Method For The Quantification Of Impurities In Fluticasone Propionate Nasal Spray. International Journal of Pharmacy and Pharmaceutical Sciences. 2020 Nov 1:80-7. PMID: 32104218 PMCID: PMC7027130 DOI: 10.3892/etm.2019.8401.
18. Lin J, Chen P, Liu C, Kang J, Xiao W, Chen Z, et al. Comparison of fluticasone propionate with budesonide administered via nebulizer: a randomized controlled trial in patients with severe persistent asthma. J Thorac Dis. 2017;9(2):372. PMID: 28275486 PMCID: PMC5334096 DOI: 10.21037/jtd.2017.02.51.
19. Pelaia G, Vatrella A, Busceti MT, Fabiano F, Terracciano R, Matera MG, Maselli R. Molecular and cellular mechanisms underlying the therapeutic effects of budesonide in asthma. Pulm Pharmacol Ther. 2016;40(6):15-21. PMID: 27381656 DOI: 10.1016/j.pupt.2016.07.001.
20. Adams NP, Lasserson TJ, Cates CJ, Jones P. Fluticasone versus beclomethasone or budesonide for chronic asthma in adults and children. Cochrane Database Syst Rev. 2007(4). PMID: 17943772 PMCID: PMC8447218 DOI: 10.1002/14651858.CD002310.pub4.
21. National Asthma Education and Prevention Program Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007 J Allergy Clin Immunol. 2007;120(5 Suppl):S94-138. PMID: 17983880 DOI: 10.1016/j.jaci.2007.09.043
22. Kaya A, Erkocoglu M, Akan A, Vezir E, Azkur D, Ozcan C, Civelek E, Toyran M, Giniş T, Misirlioglu ED, Kocabas CN. TRACK as a complementary tool to GINA and NAEPP guidelines for assessing asthma control in pre-school children. J Asthma. 2014;51(5):530-5. PMID: 24494666 DOI: 10.3109/02770903.2014.887729.
23.Maisonneuve MH, Grasemann H. Diagnosis and management of preschool asthma. CURR ALLERGY CLIN IM.2018 Jun 1;31(2):80-4.
24. Kuo LY, Hung CH, Tseng HI, Wu JR, Jong YJ, Chu YT. Effects of budesonide and fluticasone propionate in pediatric asthma patients. Pediatr Neonatol. 2010;51(1):31-6.
25. Jenkins C, Woolcock AJ, Saarelainen P, Lundback B, James MH. Salmeterol/fluticasone propionate combination therapy 50/250 μg twice daily is more effective than budesonide 800 μ g twice daily in treating moderate to severe asthma. Respir Med. 2000;94(7):715-23. PMID: 10926345 DOI: 10.1053/rmed.2000.0875.
26. Ahmadiafshar A, Mogimi Hadji M, Rezaei N. Comparison of Effectiveness between Beclomethasone Dipropionate and Fluticasone Propionate in Treatment of Children with Moderate Asthma. World Allergy Organ J .2010;3(12):250–252. PMID: 23282900 PMCID: PMC3651060 DOI: 10.1097/WOX.0b013e3181f68d92
27. Meltzer EO, Pearlman DS, Eckerwall G, Uryniak T, DePietro M, Lampl K. Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma. Ann Allergy Asthma Immunol. 2015;115(6):516-22.
28. Harrison TW, Wisniewski A, Honour J, Tattersfield AE Comparison of the systemic effects of fluticasone propionate and budesonide given by dry powder inhaler in healthy and asthmatic subjects .Thorax. 2001;56(3):186-91.
29. Axelsson I, Naumburg E, Prietsch SO, Zhang L. Inhaled corticosteroids in children with persistent asthma: effects of different drugs and delivery devices on growth. Cochrane Database Syst Rev. 2019;6(6):CD010126. PMID: 31194879 PMCID: PMC6564081 DOI: 10.1002/14651858.CD010126.pub2.
| Files | ||
| Issue | Vol 22 No 6 (2023) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijaai.v22i6.14642 | |
| Keywords | ||
| Asthma Budesonide Children Clinical trial Fluticasone propionate | ||
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How to Cite
1.
Sadeghzadeh M, Khoshnevisasl P, Ahmadiafshar A, Motamed N, Pourmarjani A. Comparing Budesonide and Fluticasone Propionate in Children with Moderate to Severe Asthma: A Pilot Randomized Controlled Trial. Iran J Allergy Asthma Immunol. 2023;22(6):527-535.
