SECTION LABEL
thrice weekly (lower dose and smaller population
(n=109) than AMAZES) with higher inhaled
steroid doses and two exacerbations in the
previous year. There was no significant difference
in exacerbation rates compared with placebo.
Patients from 18 to 75 years were eligible for
entry to study.
Overall there was a clear reduction in asthma
exacerbations (both moderate and severe).
This was seen for both eosinophilic and non-
eosinophilic exacerbations with a greater
reduction seen in eosinophilic groups.
The majority of studies demonstrated
improvement in asthma symptoms. Actual
changes were minimal and unlikely to be of
clinical significance (statistical significance was
reached in only three studies).
Azithromycin use may reduce bronchial
hyper-responsiveness in asthma and might
result in a reduction in oral steroid dose, but
this is not a consistent finding. It can result in
a small improvement in lung function and peak
expiratory flow rate; it may also result in
measurable improvements in quality of life (QoL)
but the clinical impact of these changes remains
unknown and may be very small.
There is no evidence of the impact of
macrolide therapy on mortality, exercise capacity,
disease progression or sputum production in
people with asthma, therefore no
recommendations in regard to these outcomes
can be made in this guideline.
Avoid long-term
macrolide use
in smokers,
as therapy would
be ineffective
Recommendation
Oral macrolide therapy should be considered to
reduce exacerbation frequency in adults (50–70
years), with ongoing symptoms despite >80%
adherence to high-dose inhaled steroids
(>800mcg/day of beclomethasone diproprionate
equivalent) and at least one exacerbation
requiring oral steroids in the past year. This
recommendation reflects the population within
the AMAZES 4 randomised, controlled trial (RCT),
which represents the highest quality evidence of
macrolide therapy leading to a significant
reduction in exacerbations. Treat for 6–12
months’ duration, 500mg three-times a week.
COPD
There were nine RCTs reviewed, ranging from
3 to 12 months’ duration and using different
macrolides. The mean ages of participants were
64–72 years. There was no evidence of
improvement in lung function and no mortality
benefit. There was a statistically significant
improvement in QoL measured by the St George’s
Respiratory Questionnaire (SGRQ), but not
clinically significant four-unit improvement as
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