Plymouth Health CommunityNICE Guidance Implementation Group

Asthma inhalers for routine treatment of chronic asthma in older children (aged 5 - 15 years)

Miss Faye DorisUniversity of Plymouth

The National Institute of Clinical ExcellenceClinical Guidelines

View arrived at after careful consideration of the available evidence

Health professionals are expected to consider these when making a clinical judgement

The National Institute of Clinical ExcellenceClinical Guidelines

do not ‘override the individual responsibility of health professionals, to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and or their guardian or carer’.

Previous Guidance: management of asthma in adults and children

British Thoracic Society (BTS) guideline issued in 1997 was the most commonly used in the UK

Not explicitly evidenced based

largely considered the management of asthma in adults and older children

Previous Guidance: British Thoracic Society Guidance Contd.

Principles for selection of devices stated

Recommendations about specific devices not made

The Appraisal Process

Examination of the evidence on the clinical effectiveness and cost effectiveness of inhaler devices

Stakeholder consultations

The Appraisal Process: Systematic Reviews

A review of research-based evidence on a topic in which the evidence has been systematically identified, appraised and summarised according to pre determined criteria.

Randomised Controlled Trials

A trial in which subjects are randomly assigned to either a group receiving an intervention that is being tested or control group receiving an alternative or no intervention. The results compare the results of different groups.

Clinical effectiveness: Systematic Review

The specificity of device and drug effect meant one drug in one device could not be compared to other drugs

Limited evidence found in relation to quantity and quality

Clinical effectiveness: Systematic Review

Studies claiming to demonstrate equivalence were unable to do so and some studies used inappropriate dose comparators

Available evidence therefore limited and poor

Delivery of bronchodilators- the evidence

23 studies examined Some used inappropriate

dosing schedules, which may have biased their findings

Some included a high proportion of adults

Some were small or included few children

Delivery of anti-flammatory drugs- the evidence

A number of studies were examined

The quality of the studies was variable either in relation to number of children or the use of the design

Well designed studies did not report on differences in effectiveness between devices

CFC- free devices - the evidence

No evidence of difference in CFC containing or CFC free devices

Although some reports of higher deposition of cortico steroids in HFA inhalers

Other influences on effectiveness

31 studies on ease of use, preference or compliance

quality generally poor, small numbers, some included adults

Only 11 were RCTs

Other influences on effectiveness: Key finding

Good individual (verbal) instruction was the key to good inhaler technique

Two studies found that above age 5 or 6 years this was so regardless of device

Cost effectiveness

No robust cost effectiveness or utility studies examining the use of inhalers in children aged 5 - 15 years were identified in the systematic review

Consideration and Conclusions

‘The available evidence failed to distinguish adequately between devices to suggest advantage in clinical effectiveness for one single delivery system’

Consideration and Conclusions

Limited evidence supports the use of press and breathe pMDIs with large volume spacers compared to press and breathe devices alone in the delivery of bronchodilators.

Consideration and Conclusions

Economic analysis suggests that no device should be excluded on grounds of cost effectiveness

Further research and implementation

In view of the lack of robust evidence the need for further good quality research is identified

Good practice guidance is however provided to enable use of the limited evidence available.

Plymouth Health CommunityNICE Guidance Implementation Group

Asthma inhalers for routine treatment of chronic asthma in older children (aged 5 - 15 years)

Miss Faye DorisUniversity of Plymouth