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Consensus guideline

on the use of inhaler


devices in asthma

Supported by an
educational grant
from Teva UK Ltd

Supplement produced in association with

the use of inhaler devices in asthma

Consensus guideline on the use of


inhaler devices in asthma
Mike Thomas1, Henry Chrystyn2, Jane Leyshon3, David Price4, June Roberts5, Richard Russell6
GP, Hospital Practitioner and General Practice Airways Group (GPIAG) Research Fellow, University of Aberdeen; 2Head of Pharmacy,
University of Huddersfield; 3Respiratory Team Leader, Education for Health; 4Professor of Primary Care, University of Aberdeen;
5
Respiratory Nurse Consultant to Salford Royal Foundation NHS Trust and Salford PCT; 6Honorary Clinical Senior Lecturer, National
Heart and Lung Institute
1

Introduction
Asthma is a chronic respiratory disease characterised by variable
airflow limitation and airway hyper-responsiveness. It is highly
prevalent, affecting 5.2 million people in the UK.1 Effective inhaled
medications are available, which improve symptoms, pulmonary
function and quality of life and reduce exacerbations. However, for
many patients, symptoms remain poorly controlled. 2,3 Incorrect use
of inhaler devices and/or non-compliance with inhaled medications
are among several factors that compromise asthma management .4,5
Furthermore, the result of inadequate asthma control has a significant
impact on the overall costs of asthma. In the UK, the financial
burden of this disease was estimated at almost 900million,1 with
lack of control responsible for up to 75% of costs.6

The degree of lung deposition is determined by the formulation,


the inhaler device, and the patients ability to use the inhaler
correctly8
Lung deposition can be improved with both DPIs and BAIs
versus pMDIs14,15

Particle size

Several types of inhaler device are available, including pressurised


metered-dose inhalers (pMDIs), pMDIs plus spacers, breath-actuated
pMDIs (BAIs), and dry powder inhalers (DPIs). Inhaler devices vary
greatly; for example in relative ease of use, the formulations available,
degree of lung deposition, and cost. This guideline is intended to
guide primary care healthcare professionals (HCPs) in how to select
an appropriate inhaler device for their asthma patient.

The size of the inhaled drug particles affects their lung deposition8
Smaller particles have a greater potential to penetrate narrow
airways than larger particles. This may have important
implications for controlling inflammation in the distal airways
of the lungs. Smaller particles may also show less oropharyngeal
deposition than larger particles8
Different inhaler devices contain several different particle sizes
of a particular drug, which may affect the amount of inhaled
drug that deposits in the lung16
For example, the Qvar beclometasone chlorofluorocarbon
(CFC)-free inhaler is twice as potent as CFC-containing
beclometasone inhalers at the same dose, whereas the Clenil
beclometasone CFC-free inhaler is equipotent to
CFC-containing beclometasone inhalers at the same dose17

Inhaled therapy: the concepts

Inhaler technique and compliance

Targeted delivery

Good inhaler technique is fundamental to optimal delivery of


the asthma drug and, therefore, maximum therapeutic effect4,5
Ease of use varies between inhaler devices
Poor inhaler technique is often apparent in asthma patients,
particularly with pMDIs as these require good coordination
between actuation and inhalation.2 It is estimated that 5889%
of asthma patients in the UK use these devices incorrectly18
The joint British Thoracic Society (BTS) and Scottish
Intercollegiate Guidelines Network (SIGN) asthma
management guideline recommends that, before initiating
therapy, the patients should be taught how to use the inhaler
and then must be able to demonstrate satisfactory technique.
Furthermore, patient inhaler technique should be reassessed
at regular asthma reviews (e.g. annually).17 This applies to
switching as well as initial prescriptions, as poor inhaler
technique in either circumstance can be associated with loss of
asthma control
Healthcare professionals (HCPs) need to be trained to teach
patients competently, and should keep up-to-date with new
devices

Inhalation delivers medication to the airways; therefore the drug is


delivered to the areas affected by the disease and systemic exposure
is limited
Bronchodilator drugs (anti-cholinergics and 2 agonists) target
the large to intermediate bronchi, which contain smooth muscle
and 2 receptors7,8
Inflammation occurs throughout the airways, including the
distal airways, particularly in severe asthma810
Inhaled corticosteroids (ICS) reduce airway inflammation11
However, only a proportion of the inhaled drug will be deposited
precisely where it is needed
Some of the drug will be left in the oropharynx. This undesired
deposition can cause side-effects, for example dysphonia or
thrush with ICS12
Systemic absorption of ICS can also occur through either the
gastrointestinal tract or the lungs, depending on the molecule,
inhaler device, and inhalation technique13

the use of inhaler devices in asthma

Placebo inhaler devices should be used during teaching,


although infection control issues need to be borne in mind (see
BTS website for advice on cleaning: www.brit-thoracic.org.
uk)19
Training aids are available to teach patients to use the correct
speed of inhalation20
Booklets and a CD-ROM detailing how to use inhaler devices
are available from Education for Health
(www.educationforhealth.org.uk)
Compliance to the prescribed regimen is critical to achieving
optimal clinical results with the drug and reducing asthmarelated mortality21,22
Non-compliance may be intentional (for example as a result
of regimen inconvenience or fears associated with treatment),
or non-intentional (due to poor inhaler technique or a
misunderstanding of the nature of asthma)18,21
Compliance should be monitored because it is frequently low,
particularly with ICS therapy where patients may take less than
50% of the prescribed medication22
Tools are available to monitor compliance (e.g. refills and
patient self-report forms - see www.asthmatrak.org)
Involving the patient in the choice of inhaler device may help
improve compliance rates
Inhaler technique and compliance should be evaluated before
stepping-up asthma therapy

Different types of device


Pressurised metered-dose inhalers
These were the first type of inhaler device to be introduced,
and remain the most commonly prescribed delivery system for
bronchodilators and ICS in the UK
The devices rely on a propellant to expel the drug
Traditionally, the propellants were CFCs but these are now
being phased out
Differences exist between CFC and CFC-free inhaler devices
(see separate guideline on the phasing out of CFC-containing
inhalers23)
The larger particle size typical of pMDIs results in a low level of
lung deposition16
Introduction of CFC-free propellants and molecules of smaller
particle size has led to the development of some pMDI devices
with improved lung deposition; e.g. extrafine beclometasone
(Qvar ) and ciclesonide (Alvesco )
Patients often have poor technique with pMDIs2,18
Advantages:
Consistent dose emission
Wide range of available drugs
Multi-dose
Quick to use
Small, portable, and discreet

Familiar to HCPs and patients


Typically less expensive than other inhaler devices
Disadvantages:
Complicated technique to master (see below)
High oropharyngeal deposition (lower with some CFC-free
devices due to lower emission velocity with smaller particle
size)16
Variable lung deposition 16
Associated with the cold freon effect (reduced with
hydrofluoroalkane [HFA] devices) (see Box 1)
Often difficult to know when empty or close to empty: only
one device available has a dose counter
Not easy for HCPs to teach to patients18
Test firing commonly wastes drug supply
Technique issues
Reliant on high level of coordination between actuation and
inhalation4,
A degree of manual dexterity needed24
Requires slow inhalation20
Some devices are more forgiving of poor technique (e.g. BAIs)

Pressurised metered-dose inhalers plus spacers


Box 1: Cold freon effect

The cold freon effect refers to the phenomenon whereby a


cold spray hitting the epiglottis stimulates cough and prevents
effective inhalation. This occurs particularly with
CFC-containing inhaler devices.
Adding a spacer to a pMDI increases the level of lung deposition
and lowers oropharyngeal deposition25
Spacers may be useful for younger patients, together with
tight-fitting and age-appropriate masks
Adult masks are available if required
Spacers should be replaced as per manufacturers
recommendations (typically 612 months for plastic spacers), or
if visibly damaged
Advantages:
Associated with a reduced cold freon effect
Can be used to deliver high-dose bronchodilators in severe
asthma17
Reduce the need for patient coordination with actuation and
inhalation
Disadvantages:
Potential compatibility issuesalthough some spacers can
accommodate all pMDI mouthpieces, others will only fit
specific pMDIs
Plastic spacers are susceptible to static-charge
They can be bulky and not easily portable
Spacers are often unpopular with patients26,27

the use of inhaler devices in asthma

Table 1: Inhaler devices for asthma available in the UK12,28


Device type

Available devices

pMDI

Spacer

Able Spacer , AeroChamber Plus, Babyhaler , E-Z Spacer , Fisonair , Haleraid , Nebuchamber , Nebuhaler , PARI Vortex Spacer ,
Pocket Chamber , Volumatic

BAI

Autohaler , Easi-Breathe

DPI

Accuhaler, Clickhaler, Cyclohaler, Diskhaler, Easyhaler, Novolizer, Pulvinal , Spinhaler, Turbohaler, Twisthaler

pMDI=pressurised metered-dose inhalers; BAI= breath-actuated pMDIs; DPI=dry powder inhalers.

Table 2: Selected features of each type of inhaler device for asthma


Device type
pMDI
pMDI + spacer
BAI
DPI

Size

Propellant

Small, portable,
discreet
Bulky, not easily
portable
Small, portable,
discreet
Small, portable,
discreet

Required
Ease of technique/
Cold freon effect coordination between
teaching
actuation and breath

Yes

Yes (reduced with


HFA devices)

High

Difficult

Yes

Reduced

Medium

Moderate

Yes

Yes (reduced with


HFA devices)

Low

Easy

No

No

Low

Easy

pMDI=pressurised metered-dose inhalers; HFA=hydrofluoroalkane; BAI=breath-actuated pMDIs; DPI=dry powder inhalers.


*Guide cost can vary between formulations, strengths, and molecule selected.

Technique issues:
Each actuation should be inhaled separately
Tidal breathing is effective in patients unable to take a large single
breath
Minimal delay between actuation and inhalation is required
Spacer cleaning issuespatients should be advised of the following
care instructions:17
Clean monthly
Wash in warm soapy water
Do not rinse
Air dry
After washing, wipe mouthpiece clean of detergent before use

Breath-actuated pressurised metered-dose inhalers


These more modern devices overcome some of the coordination
problems associated with press-and-breathe pMDIs because they
automatically actuate on inspiration
Devices are available for both bronchodilators and ICS
Advantages:
Overcome coordination problems between inhalation and
actuation
Few steps, easy to use
Easy for HCPs to teach
Popular with patients26
Small and portable
Relatively inexpensive
Disadvantages:
Require slow inhalation
Limited range of drugs available

Cold freon effect present, particularly with CFC formulations;


reduced with HFA devices
Cannot be used with a spacer
Unsuitable for younger children (<5 years)
Technique issues:
Autohaler device requires a moderate degree of manual dexterity
Generation of inspiratory flow is required to actuate the device

Dry powder inhalers


These breath-actuated devices were developed to overcome usage
problems associated with pMDIs
Inspiratory flow of the patient deaggregates the drug and allows
small particles to reach the bronchi, carried on the inspired air
Advantages:
No propellant
No cold freon effect
High level of lung deposition than traditional pMDIs 14,15
Wide range of available drugs
Most have a dose counter or indicator
Few steps, easy to use
Easy for HCPs to teach to patients
Small, portable, and discreet
Disadvantages:
Powder inhalation can trigger cough
Dependent on flow rate and acceleration of inspiration
May have storage restrictions: some are susceptible to humidity
so must be kept dry
Generally more expensive than pMDIs

the use of inhaler devices in asthma

Figure 1: Algorithm for the selection of the most appropriate inhaler device for each asthma patient
Decision to prescribe an inhaler device

Agree appropriateness of therapy with patient

Consider following HCP issues:

Consider following patient issues:

NAvailability of placebo device

NAge

NCost-effectiveness

NCognitive function

NEase of teaching

NDexterity

NFamiliarity with device

NEyesight

NLocal prescribing guidance

NLifestyle

Shortlist a selection of appropriate devices (


(would normally include a pMDI spacer)

For each device in shortlist:


NDemonstrate correct inhaler use to patient
NAssess patient technique after training

Consider patient preference and ensure patient


demonstrates good technique with device

Prescribe initial choice of device for


trial period, e.g. 24 weeks

Assess therapeutic effect


Poor
Review diagnosis, device
technique, and compliance

Good
Reinforce device technique,
check compliance and
arrange regular review

H Choice of device may determine choice of molecule, and vice versa


HCP=healthcare professional; pMDI=pressurised metered-dose inhaler.

Technique issues:
Patients with severe lung disease may not be able to generate
the minimum effective inspiratory flow required
Should not be exhaled into as this introduces humidity

Table 1 lists the categories of asthma inhaler devices currently


available. Table 2 summarises the main comparative aspects of each
device category.

Nebulisers

Selecting an appropriate inhaler device

Can deliver a high dose of medication without any inspiratory


manoeuvre by the patient

Evidence base

Rarely necessary in asthma and should only be prescribed after


assessment by a specialist
In acute mild to moderate asthma, a pMDI plus spacer is as least
as effective as a nebuliser17

The algorithm in Figure 1 has been developed to help guide selection


of the most appropriate inhaler device for each asthma patient
Scant randomised controlled trial evidence is available to guide
the choice of a particular inhaler device from the existing
range16

the use of inhaler devices in asthma

Guidelines from the Global Initiative for Asthma (GINA)29


and BTS/SIGN,17 which are restricted to evidence-based
methodology, provide little direction on inhaler choice due to
lack of appropriate trial data in this area
In patients with good inhaler technique it has been suggested
that alternative devices offer no benefit over pMDIs for
delivering ICS30
As such, the guidelines encourage first-line use of a pMDI17,29
However, clinical trials assessed by BTS and GINA tend to
select patients who have good inhaler technique; furthermore,
the majority of patients seen in general practice are unable to use
pMDIs appropriately16,31
Observational studies of real-world heterogeneous asthma
populations have shown:
Improved outcomes in patients treated with BAIs compared
with those using pMDIs31
Improved outcomes with DPIs versus MDIs32
Variations in outcomes when the same ICS was given as a
different DPI33

Cost-effectiveness
Cost-effectiveness must also be considered when choosing an
inhaler device6,26
Costs of inhaler devices vary widely; generally, generic pMDIs
have the cheapest unit cost and DPIs are the most expensive,
although individual formulations vary
Precise cost comparisons between inhaler devices are hampered
because of differences in dosing schedules, potency, and
formulations
Pharmacy costs account for only a small proportion of the
total cost of asthma and non-pharmacological costs tend to
be underestimated; indeed, uncontrolled asthma presents a
much larger strain on the National Health Service, accounting
for 75% of total healthcare costs of asthma, particularly when
hospital admission is required6
When all costs are considered, the device with the cheapest unit
cost is not necessarily the most cost-effective option: the most
cost-effective device is the one the patient can and will use16

Special groups
It is important to educate a patients parents and/or carers
about asthma, how to use the inhaler device correctly, and the
importance of following the prescribed treatment regimen17
Children
Aged 05 years: use pMDI plus spacer (plus a mask for those
aged <3 years) since this group cannot generate inspiratory
flow for BAIs or DPIs, or coordinate breath and actuation as
required with pMDIs alone17
Aged 512 years: as children get older they may express a
preference for a device other than a pMDI plus spacer and they
should be involved in the decision on which inhaler device to
use

Elderly
Special attention should be paid to the ability of elderly
patients to use inhalers effectively
Cognitive impairment may prevent effective training4,27
Co-morbidities may impact ability to use a device18
Manual dexterity may be reduced and affect ability to use
certain devices: there are several aids available for those with
physical disability (e.g. Haleraid , Turbohaler aid)
People with learning disabilities
Cognitive impairment may prevent effective training4
A pMDI plus spacer (with or without a mask) or a BAI may be
most appropriate in this situation
Patient choice remains important

References
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the use of inhaler devices in asthma

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This supplement has been supported by an educational grant from Teva UK Ltd.
The views and opinions of contributors expressed in this publication are not necessarily those
of Teva UK Ltd, Connectmedical or of Guidelines, its publisher, advisers and advertisers.
No part of this publication may be reproduced in any form without the permission of the publisher.


EB/07/010 Date of preparation: October 2007

Produced by Connectmedical, a division


of Medendium Group Publishing Ltd
2007 Medendium Group Publishing Ltd

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