Guidance on the use of inhaler systems (devices) in children under the age of 5 years with chronic asthma

The evidence base for pressurised metered dose inhalers (pMDIs) plus spacer versus dry-powder inhalation systems (DPI) for the delivery of corticosteroids in children with chronic asthma is relatively small and of poor quality. Two randomised controlled trials were identified, which recruited children of 5 years or under. These trials involved a total of 140 children, although the majority of these recruited children of 5 years or older. One of these trials was inadequately powered and compared a pMDI alone (not recommended by current BTS guidelines) versus DPI. The second and largest trial demonstrated no difference in steroid delivery via a pMDI plus spacer compared to DPI (at half MDI dosage).

The evidence base for pressurised metered dose inhalers (pMDIs) alone or pMDI plus spacer compared to dry-powder inhalation systems (DPI) in children with chronic asthma is poor. Four randomised controlled trials were identified that recruited children of 5 years or less. These trials involved a total of 278 children, some of whom were aged 5 years or more. The remaining 3 studies demonstrated no difference when comparing beta-2 agonist delivery via pMDI plus spacer with beta-2 agonist delivery by DPI.

The evidence for nebulised bronchodilators compared with bronchodilator delivery via hand-held device in children with chronic asthma is also poor. Three randomised controlled trials which recruited children aged 5 years or less, were identified. These trials were small and involved a total of 51 children, although many of the children were aged 5 years or older. No differences were found between nebulisation, pMDIs or dry powder devices. These trials are likely to be of insufficient size to detect small differences between devices.

There is currently a wide range in the cost of drug and inhaler combinations. No cost-effectiveness studies were identified that make direct comparison between asthma devices in children under the age of 5 years with chronic asthma.

See the section on sources of evidence for documentation and opinions available to the appraisal committee.