Effective treatment of respiratory symptoms, airway inflammation and impairment of lung function is the goal of any asthma therapy. Although montelukast has been shown to be a possible add-on therapy for anti-inflammatory treatment in older children, its efficacy in infants and young children is not well known. The aim of this study was to investigate its effect in infants and young children with early childhood asthma.In a prospective randomised double-blind placebo-controlled study, 24 young children (10-26 months) with wheeze, allergy and a positive family history of asthma consistent with the diagnosis of early childhood asthma were randomised to receive montelukast 4 mg or placebo. The forced expiratory volume in 0.5 seconds (FEV0.5) was measured using the raised volume rapid thoracic compression technique, and fractional exhaled nitric oxide (FeNO) and symptom scores were determined.No change was noted in FEV0.5, FeNO or symptom score in the placebo group following the treatment period. In contrast, significant improvements in mean¡SD FEV0.5 (189.0¡37.8 and 214.4¡44.9 mL before and after treatment, respectively), FeNO (29.8¡10.0 and 19.0¡8.5 ppb) and median symptom score (5.5 and 1.5) were noted following treatment with montelukast.In conclusion, montelukast has a positive effect on lung function, airway inflammation and symptom scores in very young children with early childhood asthma.

There is still a lack of knowledge in the field of aerosol therapy in children, particularly in young children. The amount of drug delivered from a commercially available inhalation device that reaches the lungs of children is generally low. The choice of an optimal combination of delivery device and drug formulation based on individual patient related factors is crucial. Aerosols with a small MMAD and a narrow GSD are required for a sufficient inhalation therapy in early childhood. The development of combinations of delivery devices and drug formulations fulfilling the requirements for an efficient inhalation therapy in young children is likely to increase the therapeutical options in this age group.

We examined the effect of inhaled fluticasone diproprionate (FDP) on symptoms, lung function (FEV(0.5)), and exhaled nitric oxide (Fe(NO)) in infants with recurrent wheeze and raised Fe(NO). Thirty-one infants aged 6-19 months (mean, 12.7 months; 12 girls) completed the study. All infants had a history of recurrent wheeze and a parental history of atopy. All children had raised Fe(NO), as determined by an offline tidal breathing technique prior to randomization. Lung function and Fe(NO) were assessed before and after 4 weeks of treatment with FDP or placebo. The parents recorded daily symptoms during the treatment period. Sixteen infants received FDP and 15 the placebo for 4 weeks. At completion of the study, infants treated with FDP had a significant reduction in Fe(NO) (35.0 ppb to 16.5 ppb) compared to those that received placebo (35.2 ppb to 30.2 ppb) (P = 0.05). Small increases in FEV(0.5) were observed in both groups, but these changes were not different between groups (P = 0.8). Symptom scores were not significantly different in either group following the intervention. We showed that a moderate dose of inhaled FDP reduces levels of Fe(NO), a potential marker of airway inflammation, even in the absence of significant changes in lung function and symptoms.

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We investigated the in vitro influence of breathing patterns on lung dose (LD) and particle size distribution in an infant upper airway cast model in order to determine the optimal particle size for nebulized aerosol delivery to infants. Budesol (nebulizer solution of budesonide) delivery from a perforated vibrating membrane nebulizer (eFlow Baby functional prototype) through an upper airway cast of a nine month old infant (SAINT-model) was measured at a fixed respiratory rate (RR) of 30 breaths per minute (bpm) and a tidal volume (Vt) of 50, 100, and 200 mL, respectively, and at a fixed Vt of 100 mL and a RR of 30, 60, and 78 bpm, respectively. LD expressed as a percentage of the nominal dose (ND; range, 5.8-30.3%) decreased with increasing Vt (p < 0.001) and with increasing RR (p < 0.001). Median mass aerodynamic diameter (MMAD) after passage (range, 2.4-3.4 microm) through the upper airway cast showed a negative correlation with increasing Vt (p < 0.001) and with increasing RR (p = 0.015). Particles available as LD for all simulated breathing pattern showed a particle size distribution with a MMAD of 2.4 microm and a geometric standard deviation (GSD) of 1.56. From our in vitro study, we conclude that the optimal particle size for nebulized aerosols for inhalation therapy for infants should have a MMAD of <2.4 microm.