Article
Asthma drug adherence in a long term clinical trial
Gunnar Jónassona, Kai-Håkon Carlsenb, Petter Mowinckelc
a Paediatric Section
for Allergy and Pulmonology, Ullevål Hospital, 0407 Oslo, Norway, b Voksentoppen Centre of
Allergy, Asthma and Chronic Lung Diseases in Children, Oslo, Norway, c Health Services Department,
Central Hospital of Akershus, Norway
Correspondence to: Dr Jónasson email: gjonasso{at}online.no
Accepted 8 June 2000
AIM
To measure drug adherence in
children with mild asthma receiving long term prophylactic treatment.
METHODSDouble blind
randomised placebo controlled trial. Patients received inhaled
budesonide 100 µg or 200 µg daily, or placebo for 27 months. All
participants were asked to inhale medication or placebo from two
different Turbuhalers (morning and evening) during the study. A total
of 122 children (80 boys, 42 girls) aged 7-16 years with mild asthma
(mean FEV1 103.7% of predicted) were included in the
trial. Drug adherence was assessed by counting the number of remaining
doses in the inhaler when study medication was returned at six month intervals.
RESULTSA statistically significant
and continuing decrease in measured drug adherence was found from three
to nine months and then to 27 months, reaching mean values of 40.6%
and 46.9% for inhaled morning and evening medication respectively.
Drug adherence declined more rapidly in the placebo group (compared to
active treatment); this difference became significant after two years
of treatment. Children aged 9 years or less had better drug adherence
during the entire study period, but the difference was only significant for the first three months of the study. Measured drug adherence was
significantly higher for evening medication compared to morning medication for all study intervals after nine months.
CONCLUSIONMeasured drug adherence
diminishes significantly when treating children with mild asthma in a
long term trial. This emphasises the importance of monitoring
compliance in clinical trials.
Keywords: drug adherence; patient compliance; inhaled corticosteroids; childhood asthma
© 2000 by Archives of Disease in Childhood
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