Skip to main content


Log in

Once-Daily vs. Twice-Daily Administration of Inhaled Budesonide for Mild and Moderate Well-Controlled Childhood Asthma: A Randomized, Controlled Trial

  • Original Article
  • Published:
Indian Journal of Pediatrics Aims and scope Submit manuscript



To compare median change in morning peak expiratory flow rate (PEFR) and clinical asthma control in children receiving total daily dosage of inhaled budesonide administered either as once-daily or divided twice-daily dose.


It was a randomized, parallel group, open label, noninferiority trial on 80 children aged 5–12 y with mild or moderate well-controlled asthma. Baseline parameters were recorded and subjects received inhaled budesonide either as once-daily or divided twice-daily dose. Primary outcome was median change in morning PEFR. Secondary outcomes included median change in evening and diurnal variation in PEFR, asthma symptom control as per Global Initiative for Asthma, 2017 and Asthma Control Questionnaire, and spirometric measurements taken at the clinic.


The median [interquartile range (IQR)] increase in morning PEFR was more in children receiving once-daily as compared to those receiving twice-daily inhaled budesonide (by 6:00 L/min; IQR: −44.00–63.00 L/min vs. 4:00 L/min; IQR: −67.50–67.50 L/min, p 0.222; 95% CI: −1.37 to 19.08). Other spirometric variables and symptoms scores were also nonsignificant except median change in evening PEFR which was in favor of twice-daily regimen.


Once-daily administration of inhaled budesonide is noninferior to twice-daily administration of equivalent daily dosage of inhaled budesonide.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Subscribe and save

Springer+ Basic
EUR 32.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or Ebook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

Data Availability



  1. Global Initiative for Asthma; Global Strategy for Asthma Management and Prevention, 2017. Available at: Accessed on 1 Oct 2017.

  2. Van Aalderen WMC, Sprikkelman AB. Inhaled corticosteroids in childhood asthma: the story continues. Eur J Pediatr. 2011;170:709–18.

    Article  CAS  Google Scholar 

  3. Chauhan BF, Ducharme FM. Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children. Cochrane Database Syst Rev. 2012;5:CD002314.

    Google Scholar 

  4. Park G-M, Han HW, Kim JY, et al. Association of symptom control with changes in lung function, bronchial hyperresponsiveness, and exhaled nitric oxide after inhaled corticosteroid treatment in children with asthma. Allergol Int. 2016;65:439–43.

    Article  CAS  Google Scholar 

  5. Reddel HK, Busse WW, Pedersen S, et al. Should recommendations about starting inhaled corticosteroid treatment for mild asthma be based on symptom frequency: a post-hoc efficacy analysis of the START study. Lancet. 2017;389:157–66.

    Article  Google Scholar 

  6. Singh V, Chugh K, Kabra SK, Parakh A, Sehgal V. Asthma By Consensus. Consensus Guidelines for Diagnosis and Management of Asthma in Children. New Delhi: Indian Academy of Pediatrics; 2016.

  7. Weiner P, Weiner M, Azgad Y. Long term clinical comparison of single versus twice daily administration of inhaled budesonide in moderate asthma. Thorax. 1995;50:1270–3.

    Article  CAS  Google Scholar 

  8. Boulet LP, Cowie RL, Negro RD, et al. Comparison of once- with twice-daily dosing of fluticasone propionate in mild and moderate asthma. Can Respir J. 2000;7:239–47.

    Article  CAS  Google Scholar 

  9. Möller C, Strömberg L, Oldaeus G, Arweström E, Kjellman M. Efficacy of once-daily versus twice-daily administration of budesonide by Turbuhaler(R) in children with stable asthma. Pediatr Pulmonol. 1999;28:337–43.

    Article  Google Scholar 

  10. Woodcock A, Bleecker ER, Busse WW, et al. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011;12:160.

    Article  CAS  Google Scholar 

  11. Mallol J, Aguirre V. Once versus twice daily budesonide metered-dose inhaler in children with mild to moderate asthma: effect on symptoms and bronchial responsiveness. Allergol Immunopathol (Madr). 2007;35:25–31.

    Article  CAS  Google Scholar 

  12. Price D, Robertson A, Bullen K, Rand C, Horne R, Staudinger H. Improved adherence with once-daily versus twice-daily dosing of mometasonefuroate administered via a dry powder inhaler: a randomized open-label study. BMC Pulm Med. 2010;10:1.

    Article  Google Scholar 

  13. Reinberg A, Halberg F, Falliers CJ. Circadian timing of methylprednisolone effects in asthmatic boys. Chronobiologia. 1974;1:333–47.

    CAS  PubMed  Google Scholar 

  14. Pincus DJ, Szefler SJ, Ackerson LM, Martin RJ. Chronotherapy of asthma with inhaled steroids: the effect of dosage timing on drug efficacy. J Allergy Clin Immunol. 1995;95:1172–8.

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations



MG: Acquisition of data; MG, PK: Analysis and interpretation of data; MG, PK, SR: Drafting of the manuscript; VG, PK: Conception and design; VG, PK, SR: Critical revision of the manuscript for important intellectual content; MG, VG, PK, SR: Final approval of the version to be published and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. VG will act as guarantor for this paper.

Corresponding author

Correspondence to Pankaj Kumar.

Ethics declarations

Ethics Approval

The study was conducted in line with the ethical guidelines for biomedical research on human subjects as given by Central Ethics Committee on Human Research (CECHR), ICMR, New Delhi, 2006, and followed the tenets of Declaration of Helsinki, 2008. The trial was approved by the Institutional Ethics Committee, Government Medical College and Hospital, Chandigarh, India (Date: 08.12.2017).

Consent to Participate and/or Consent for Publication

Written informed consent was obtained from parents or legal guardian.

Conflict of Interest


Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Goyal, M., Guglani, V., Kumar, P. et al. Once-Daily vs. Twice-Daily Administration of Inhaled Budesonide for Mild and Moderate Well-Controlled Childhood Asthma: A Randomized, Controlled Trial. Indian J Pediatr 89, 13–18 (2022).

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: