Comparative efficacy of nebulised salbutamol, salbutamol plus budesonide and salbutamol plus fluticasone in the management of  acute exacerbation of bronchial asthma in children: a study protocol of a randomized controlled trial

Rachna Pasi; Thirunavukkarasu Arun Babu

doi:10.18203/2349-3259.ijct20263759

Authors

Rachna Pasi Department of Pediatrics, AIIMS Delhi, New Delhi, India https://orcid.org/0000-0003-4889-7905
Thirunavukkarasu Arun Babu Department of Pediatrics, AIIMS, Mangalagiri, Andhra Pradesh, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20263759

Keywords:

Budesonide, Fluticasone, Asthma, Salbutamol, Corticosteroids

Abstract

Background: Acute exacerbation of asthma in children is one of the most common emergencies in children. Use of inhaled corticosteroids (ICS) in combination with bronchodilator as initial therapy has shown to be beneficial when compared to oral corticosteroids. ICS commonly used in acute exacerbation in children are budesonide and fluticasone. Pediatric respiratory assessment measure (PRAM) Score is widely used standardized score in clinical and as well in research studies for 2-17years children. It has five parameters with total scores from 0-10 where higher scores indicate sicker patient.

Methods: This study is planned to study efficacy of nebulised salbutamol vs salbutamol plus budesonide vs salbutamol plus fluticasone in management of acute exacerbation of asthma in children. After written informed consent, participants will be enrolled by computerized block randomization list to three groups. Each group will be administered the medication as per their allocation and weight band. Vitals and PRAM score will be recorded 0, 2 and 4 hours from the start of treatment. PEFR will be recorded with help of peak flowmeter at 2 hours and 4 hours from initiation of treatment. At the end of 4 hours, patient outcome will be noted. After 3 months, child will be followed to know level of control of symptoms as per GINA guidelines. Concealment will be disclosed after statistical analysis performed and results are locked.

Conclusions: If this intervention study shows evidence of a significant difference between three arms of treatment, then it may guide first line of treatment of acute exacerbation of paediatric asthma.

Trial Registration: CTRI/2023/07/054624 registered prospectively.

References

Andrew HL, Ronina AC, Joseph DS, Scott HS. Childhood asthma. In: Kliegman R, Stanton B, Behrman RE, St. Geme JW, Schor NF editors. Nelson’s textbook of pediatrics. 20th ed. Philadelphia: Saunders. 2016;1095-115.

GBD compare, Viz hub. Available at: https://vizhub.healthdata.org/gbdcompare/. Accessed on 03 July 2026.

Singh MS, Sundeep, Singh V. Prevalence, time trends and treatment practices of asthma in India: Global Asthma Network study. ERJ Open Res. 2022;8(2):00528-2021.

Inayat N, Shah RH, Rahu QA, Sahito R. Nebulized salbutamol with and without ipratropium bromide in the treatment of acute severe asthma. Pak J Chest Med. 2016;22:102-6.

Aaron SD. The use of ipratropium bromide for the management of acute asthma exacerbation in adults and children: a systematic review. J Asthma. 2001;38:521-30.

Sawanyawisuth K, Chattakul P, Khamsai S. Role of Inhaled Corticosteroids for Asthma Exacerbation in Children: An Updated Meta-Analysis. J Emerg Trauma Shock. 2020;13(2):161-6.

Arulparithi CS, Babu TA, Ravichandran C. Efficacy of Nebulised Budesonide versus Oral Prednisolone in Acute Severe Asthma. Indian J Pediatr. 2015;82:328-32.

Edmonds ML, Milan SJ, Camargo CA Jr, Pollack CV, Rowe BH. Early use of inhaled corticosteroids in the emergency department treatment of acute asthma. Cochrane Database Syst Rev. 2012;12(12):CD002308.

Demirca BP, Cagan H, Kiykim A. Nebulized fluticasone propionate, a viable alternative to systemic route in the management of childhood moderate asthma attack: A double-blind, double-dummy study. Respir Med. 2015;109(9):1120-5.

Alnaji F, Zemek R, Barrowman N, Plint A. PRAM score as predictor of pediatric asthma hospitalization. Acad Emerg Med. 2014;21(8):872-8.

British Thoracic Society Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma Quick Reference Guide. 2016.

Amir Najim Abood HA, Al-Musawi ZM, Hussein AM, Hameed RM. Effects of nebulized budesonide plus salbutamol and nebulized salbutamol monotherapy on mild to moderate acute exacerbation of asthma in children: A comparative study. J Pak Med Assoc. 2021;71(9)12:S29-S34.

Global initiative for asthma. Global Strategy for Asthma Management and Prevention 2022. GINA Report. 2022.

Direkwattanachai C, Aksilp C, Chatchatee P, Jirapongsananuruk O, Kamalaporn H, Kamchaisatian W, et al. Practical considerations of nebulized corticosteroid in children with acute asthmatic exacerbation: A consensus. Asian Pac J Allergy Immunol. 2021;39(3):168-76.

Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019;321(16):1610-20.