Effective Once-Daily Administration of Budesonide Inhalation Suspension by Nebulizer with Facemasks or Mouthpieces for Persistent Asthma in Infants and Young Children

Abstract

This study is a retrospective analysis comparing nebulized budesonide inhalation suspension(BIS; Pulmicort Respules™, AstraZeneca, Wilmington, DE) administered once daily by facemask or mouthpiece in 359 infants and young children with persistent asthma. The efficacy and safety of once-daily BIS (0.25, 0.5, and 1.0 mg) administered by facemask or mouthpiece were demonstrated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study reported by Kemp et al. (Ann Allergy Asthma Immunol 1999; 83:231-239). Three hundred fifty-nine children aged 6 months to 8 years with mild, persistent asthma received nebulized BIS 0.25, 0.5, or 1.0 mg once daily or placebo for 12 weeks via facemask or mouthpiece. Efficacy variables included nighttime and daytime asthma symptom scores, use of breakthrough bronchodilator medications, and pulmonary function tests (in children capable of consistently performing spirometry or peak flows). Changes in nighttime and daytime asthma symptom scores were not significantly different between children using facemasks and those using mouthpieces. Use of breakthrough medications and pulmonary function test results (in the subset of children able to perform them) also were not significantly different in facemask users and mouthpiece users. These results suggest that BIS is equally effective whether administered by facemask or mouthpiece and that young children who require the use of a facemask may be successfully treated. (Pediatr Asthma Allergy Immunol 2001; 15[1]:3-13.)

Episodic use of an inhaled corticosteroid or leukotriene receptor antagonist in preschool children with moderate-to-severe intermittent wheezing

“…Placebos were identical to active drugs in terms of appearance and taste and were also donated by the makers of the active agents. Nebulized medications were administered using a PariLC Plus® nebulizer and a tight-fitting face mask or mouth-piece depending upon the age of the child, as both delivery methods have been demonstrated to be comparably effective in improving clinical parameters in infants and young children 21, 22. All participants received albuterol inhalation treatments (Proventil HFA® via AeroChamber with Mask 180 mcg/treatment (Monhagan Medical Corp, Plattsburgh, NY) or Proventil® nebulization solution 2.5 mg/treatment, donated by ScheringPlough) four times daily while awake (plus as needed) for the first 48 hours followed by albuterol use on an as needed basis.…”

Effect of Mask Dead Space and Occlusion of Mask Holes on Delivery of Nebulized Albuterol

“…2,3 Clinical studies have demonstrated equal efficacy of inhaled corticosteroids when inhaled via either a mouthpiece or a mask. 4,5 Other studies performed in pediatric subjects experiencing an exacerbation showed either no difference or better outcomes with a mouthpiece compared with a face mask. 6,7 The use of a mouthpiece is preferred over a mask because it reduces ocular and facial exposure to inhaled drugs.…”

Nebulization Therapy for Asthma: A Practical Guide for the Busy Pediatrician

“…78 Furthermore, 2 retrospective analyses showed that nebulized BIS is similarly effective whether administered via mouthpiece or face mask. 79,80 A blow-by technique can be used for infants if absolutely necessary, but it is generally not recommended 4,81 because of poor aerosol deposition. 82 If blow-by technique has to be used, a capped T-piece delivery system, rather than a mask, appears to deliver more inhaled drug to the child.…”