Doxofylline as a steroid-sparing treatment in Mexican children with asthma

Abstract

Objective

The aim of this pilot study was to assess the efficacy of doxofylline as an ICS-sparing agent in the treatment of Mexican children with asthma.

Methods

10-week, open-label, crossover, pilot study, we examined the steroid-sparing effect of doxofylline in Mexican children with asthma. Patients aged 6–16 years treated with inhaled corticosteroids (ICS) for at least 8 wk before enrollment were divided randomly into two groups at the baseline visit. Group A (n = 31) received doxofylline (18 mg/kg/day) plus standard-dose budesonide (D + SDB) for the first 4-week period followed by doxofylline plus reduced-dose budesonide (D + RDB) for the second 4-week period. Group B (n = 30) received D + RDB followed by D + SDB. Clinical outcomes assessed included lung function (forced expiratory volume; in 1 s, FEV1), fractional exhaled nitric oxide (FeNO), asthma control, number of exacerbations and use of rescue medication (salbutamol).

Results

It was shown that combined use of doxofylline and ICS may allow children with asthma to reduce their daily dose of ICS while maintaining lung function and improving asthma control (p = 0.008). There were few asthma exacerbations and only one patient required treatment with systemic corticosteroids. Rescue medication use decreased significantly in patients receiving D + SDB during the first 4-week period.

Conclusions

Our results suggest that doxofylline may be a steroid-sparing treatment in asthma, but longer-term, controlled studies are needed to confirm these observations.

Keywords:

• xanthine
• asthma
• corticosteroids
• budesonide
• exacerbations
• allergy
• lung function

Acknowledgements

The authors would like to acknowledge Dr Deirdre Elmhirst (Elmhirst Medical Writing Services) for medical writing assistance with the preparation of this manuscript, funded by Eurodrug Laborotories B.V.

Disclosure statement

Sandra Nora González-Díaz MD, PhD, reports personal fees from Astra Zeneca, Faes Farma, and Sanofi, outside the submitted work. Ignacio J. Ansotegui MD, Ph.D., reports personal fees outside the submitted work from Abbott, Amgen, Bayer, Bial, Faes Farma, Hypera, Menarini, Organon, Roxall, Sanofi, and UCB. Macouzet-Sánchez C, Acuña-Ortega N, de la Cruz-de la Cruz C report no known conflicts of interest.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.