Delivery of a beta2 agonist by metered dose inhaler with a bottle spacer was equivalent to delivery by conventional spacer in young children with acute lower airway obstruction.

In young children with acute lower airway obstruction, is response to bronchodilator treatment given using a metered dose inhaler (MDI) with a bottle spacer equivalent to that given using a conventional spacer?METHODSDesign: randomised controlled equivalence trial. Allocation: concealed.Blinding: blinded ({healthcare providers, data collectors},* and clinical outcome assessors).Follow up period: after completion of 3 bronchodilator treatments.Setting: a children's hospital in Cape Town, South Africa.Patients: 400 children aged 2 months to 5 years (median age 12 mo, 39% boys) who presented with clinical signs of acute lower airway obstruction (expiratory wheeze on auscultation or hyperinflation of the chest) and had cough or difficulty breathing within the previous 5 days. Exclusion criteria were bronchodilator use in the previous 4 hours, underlying cardiac or chronic pulmonary disease (other than asthma), stridor, or daily oral corticosteroid treatment for >2 days before presentation.Intervention: salbutamol, 500 microg, 5 puffs given at 1 puff every 10 seconds from an MDI using a modified 500 ml plastic bottle spacer, where the end of the bottle was held in the mouth simulating a mouthpiece (n = 200), or using a conventional spacer (Aerochamber, Trudell Medical, London, Ontario) (n = 200). A facemask was used for children <3 years of age. Children were reassessed 15 minutes after bronchodilator administration; if no improvement, a repeat inhalation was given, and if no improvement after 15 minutes, a third inhalation was given, and condition was reassessed after 15 minutes. If further treatment was required, children received nebulised salbutamol, 5 mg in 2.5 ml normal saline, using a jet nebuliser, and were reassessed after 15 minutes.Outcomes: admission to hospital (criteria for admission: room air oxygen saturation <92% after 3 bronchodilator treatments, persistent subcostal retractions, cyanosis, or social circumstances precluding safe home care of the acute episode). Equivalence was defined as </=10% absolute increase in hospital admission with the bottle spacer. Secondary outcomes included change in Asthma Severity Scale clinical score, change in oximetry, number of bronchodilator treatments, and need for systemic corticosteroids.Patient follow up: 100% (intention to treat analysis).MAIN RESULTS60 children (15%) were admitted to hospital. 15% of children in each of the bottle spacer and conventional spacer groups were admitted to hospital. The upper limit of the 90% confidence interval (ie, the largest benefit that could reasonably be expected with a conventional spacer) was 5.9%, and so the criteria for equivalence (<10% difference between groups) was met. Assuming this maximal difference of 5.9% (as above), 1 additional child would be admitted to hospital for every 17 children treated with a bottle spacer. The groups did not differ any of the secondary outcomes.CONCLUSIONIn young children with acute lower airway obstruction, )32 agonist administration using a metered dose inhaler with a bottle spacer was equivalent to administration using a metered dose inhaler with a conventional spacer for hospital admissions.* Information provided by author. [ABSTRACT FROM AUTHOR]