Evaluation of pulsed and breath-synchronized nebulization of budesonide as a means of reducing nebulizer wastage of drug.
The aim of this open, randomized, crossover study was to compare the inhaled mass of budesonide suspension delivered by nebulization, using constant output, breath-synchronized, or pulsed jet nebulization techniques. The inhaled mass was defined as the amount of drug deposited on a filter between the inspiratory port of the nebulizer and the face mask or mouthpiece used by the subjects. The breath-synchronized nebulization delivered aerosol during the whole inspiration, whereas the pulsed nebulization was adjusted to deliver aerosol for up to 1 sec from the start of inspiration. Budesonide suspensions, 2 mL of 0.5 mg mL(-1), or 2 mL of 0.25 mg mL(-1), in single-dose respules, were used (AstraZeneca R&D Lund, Lund, Sweden). Eleven children (7 boys, age range 2.5-5.8 years) with either a clinical suspicion or a confirmed diagnosis of asthma and 11 healthy adolescents and adults (6 male, age range 13-52 years) were enrolled. With constant output nebulization, the median inhaled mass of budesonide was about 17.6% (range 9.6-21.2%) of the nominal dose (i. e., dose of drug in the respule per label claim) in adolescents and adults, and 18.1% in children (15.7-21.4%). With pulsed nebulization the median inhaled mass increased to 23.4% (22.0-28.1%) in children and to 32.8% (24.8-38.0%) in adolescents and adults (P < 0.001). With breath-synchronized nebulization median inhaled mass increased to 30.1% (21.7-28.1%) in children, but was unchanged (30.8%, 27.0-38. 0%) in adolescents and adults. The mode of nebulization (i.e., constant or breath-synchronized) had a statistically significant effect on the inhaled mass in children and adolescents or adults (P < 0.001). There was a statistically significant difference in inhaled mass between the breath-synchronized and pulsed nebulization in children only (P < 0.05). The results support the use of breath-synchronized but not pulsed nebulization with conventional nebulizers. The results of pulsed nebulization in children warrants further clinical studies.
Nikander
K
K
AstraZeneca R & D Lund, Lund, Sweden, and Department of Clinical Physiology, Malmö General Hospital, Malmö, Sweden. Kurt.Nikander@astrazeneca.com
Turpeinen
M
M
Wollmer
P
P
D000293:Adolescent; D000328:Adult; D000336:Aerosols; D001249:Asthma / Q000188:drug therapy; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D002675:Child, Preschool; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D012119:Respiration
D000336:Aerosols; D001993:Bronchodilator Agents; D019819:Budesonide