Efficacy of Metered Dose Inhaler (MDI) with attached Bottle spacer for bronchodilator therapy in infants and young children with acute lower airways obstruction (South Africa)

INTERVENTION: This is an equivalence study. Equivalence will be regarded as not more than an absolute 10% increase in hospitalisation with the bottle spacer. Assuming that hospitalisation with the conventional spacer will occur in 20% of children and that the spacers are equally effective, 198 children will be required in each group (total sample of 396 children) to demonstrate that hospitalisation with the bottle spacer is not more than 10% higher, with 80% power and a one‐tailed a of 0.0505 i.e. given the above assumptions, the upper 90% confidence limit for a difference favouring the conventional spacer will be less than 10%. Three different delivery systems will be compared: 1. Conventional spacer with MDI ‐ a small volume (150 ml) valved spacer with an attached mask for children less than 3 years, and a mouthpiece for those 3 ‐ 5 years 2. Modified 500 ml plastic bottle with MDI with attached mask for children less than 3 years 3. Jet nebuliser with attached mask or mouthpiece depending upon child's age CONDITION: Acute lower airways obstruction ; Respiratory ; Acute lower airways obstruction PRIMARY OUTCOME: The need for hospitalisation: this outcome has been chosen as this is clinically important and can be reliably measured. Differences between the two treatment groups for this primary outcome as a result of bias should be minimised by use of random allocation of treatment group with adequate allocation concealment and adequate blinding of the investigators deciding on hospitalisation. SECONDARY OUTCOME: 1. Change in clinical score, measured as the difference between the clinical score at presentation to the clinical score recorded after the final bronchodilator treatment prior to discharge or hospitalisation; 2. Change in oximetry, measured as the difference between oximetry recorded at presentation the room air to that recorded after the final bronchodilator treatment prior to discharge or hospitalisation; 3. Number of bronchodilator treatments required prior to discharge (if not hospitalised). A bronchodilator treatment will be regarded as 5 puffs of salbutamol or a nebulisation; 4. Need for systemic corticosteroids. Systemic steroids will be indicated for children with recurrent wheeze who require hospitalisation or who have required two or more bronchodilator treatments INCLUSION CRITERIA: 1. Age 3 months to 5 years 2. Able to use MDI ‐ spacer as assessed by the researcher administering inhaled treatment 3. Acute episode of lower airway obstruction (wheezing or hyperinflation) 4. Informed consent of parent/guardian