Public Assessment Report for paediatric studies submitted in ...

that the bronchodilating effect of 100 μg dose of salbutamol from Easyhaler with low inspiratory flow
was eual to that of 100 μg dose of salbutamol from the MDI with spacer when optimal inhalation
technique was applied. This result was achieved despite the equivalence criterion for AUC of FEV 1 was
not completely met due to the low number of patents in the analysis. Easyhaler and the MDI with spacer
were equally safe and well accepted.
- The third study (8) was designed to compare the efficacy, safety and acceptability of the
Easyhaler device with those of a pMDI (Glaxo&Wellcome, UK) and a spacer in asthmatic children
(n=40, mean age 11, range 6 - 16 years). The children were treated with inhaled beclometasone
(400 μg/day) and salbutamol (100 μg/day). The primary efficacy variable was morning PEF. Secondary
efficacy variables were evening PEF, the number of sympathomimetic inhalations, daily symptom scores,
and spirometry performed at follow-up visits. Both types of inhalers, Easyhaler and the pMDIs with a
spacer, gave similar bronchodilating effect suggesting equal clinical efficacy. The children had moderate
or severe asthma, but were well controlled before entering the study. This left not much room for
improvement in either of the study treatments. However, the patients were well documented asthmatics
who needed regular anti-inflammatory treatment with inhaled glucocorticoids. t would have been
unethical to first withdraw the steroid treatment to test the reversibility of the children’s bronchial
obsruction. The study was open, but randomised and of crossover design. One of the primary outcome
measures was the acceptability of the devices. The majority of the children rated the Easyhaler device
easier to handle and use compared to the pMDIs with spacer.
-The fourth study (9) was a 4 week, open, randomised multicenter parallel group trial
evaluating correct use and acceptability of Diskus, Turbuhaler, and Easyhaler DPIs among inhaler
naive asthmatics or patients with asthma symptoms. The study population consisted of 326
subjects aged 13 years or older (mean age 44, SD 15.4). The subjects were asked to read the
instruction leaflet before taking one dose at the first visit. The correct use was evaluated when
the subject took the dose. The subjects were subsequently instructed in correct use of the devices.
At the first visit, the proportions of subjects who used the devices correctly were as follows:
Easyhaler, 45%; Diskus, 43%; and Turbuhaler, 51%. The corresponding figures at the last visit were
84%, 89%, and 81%. The differences at any visit were not statistically significant. Acceptability was
greater for Easyhaler and Diskus for 3 of 8 assessment items in the study, all pertaining to receiving
the powder from the device and control of the inhalation of the powder.
An additional study by Malinen and co-workers (10) has also been included in the line listing,
but this study does not involve patients less than 19 years of age and is thus not dealt with here.
The SPC texts of Buventol Easyhaler products reflect adequately the current knowledge about
salbutamol use in children older than 4 years. Based on the mentioned studies no changes in SPCs of
Buventol Easyhaler are thus needed.
The current posology for Buventol Easyhaler (both 100 and 200 μg/dose strengths) is the
following:
The lowest effective doses of inhaled salbutamol are recommended to be used in the treatment of
asthma. In the long term treatment it is recommended, instead of regular use, to use inhaled
salbutamol as needed.
Adults and children (4 years and older):
For the treatment of acute periods of reversible bronchoconstriction or prior to exercise usually:
100–200 micrograms 1-4 times daily.
Patients have to be instructed to perform a strong and deep inhalation through the Easyhaler
device. Patients have to be instructed not to exhale into the device.
There is wide consensus that inhaled short acting β 2 agonists are the most effective reliever
therapy, and are therefore the recommended treatment for asthma for children of all ages. Salbutamol,
Salbutamol Final Public Assessment Report
RO/W/0001/pdWS/001
Page 48/76