The Specialist Forum Volume 13 No 11 November 2013 | Page 54

ASTHMA

Safety and effectiveness of
budesonide in asthma patients

I

nhaled corticosteroid (ICS) is the first-line treatment for the management of asthma not controlled by on-demand short-acting ?2 agonists
(SABA), and is the mainstay of asthma therapies today. A SABA is often
prescribed with ICS for relief of occasional breakthrough symptoms during
ICS treatment, but overuse of SABA for quick relief of asthma symptoms
has been associated with poor asthma control.
Achieving and maintaining asthma control with the minimal effective
dose of medication(s) used is the goal of all asthma therapies.
Complexity of treatment regimens, poor adherence and flawed inhalation
techniques are known factors contributing to suboptimal asthma treatment
outcomes. For adult patients whose asthma remains uncontrolled despite
regular inhalation of a low-to-medium dose of ICS, current clinical practice
guidelines recommend a step-wise approach that is based on patient’s attainment of his/her asthma control, which might include increasing the existing low-dose ICS inhalation or adding on to low-dose inhaled ICS therapy
a long-acting ?2 agonist (LABA) for control of lung function and symptoms,
and to reduce the risk of exacerbations, and optionally, an additional SABA
for as-needed rapid relief of breakthrough symptoms in poorly controlled
cases. If this approach fails to control the asthma, a further stepwise addition of a leukotriene receptor antagonist (LTRA) or theophylline could be
considered.

Budesonide
Budesonide/formoterol in a single inhaler for both maintenance and reliever
therapy is now an established therapeutic option for management of inadequately controlled asthma. This single inhaler budesonide/formoterol
maintenance and reliever therapeutic strategy is an approach recognised
by regulatory authorities in many countries and is now recommended by
the Global Initiative for Asthma (GINA) for treatment of adult patients with
uncontrolled asthma, which GINA defines as having an exacerbation or at
least three of the following in a given week: daytime symptoms >2 times/
week, any limitation of activities, any nocturnal symptoms/awakenings,
need for reliever treatment >2 times/week or lung function <80% predicted
normal.
In controlled clinical trials, the single inhaler budesonide/formoterol maintenance and reliever therapeutic approach has been shown to be more
effective than conventional best practices in achieving asthma control, with
a safety profile that is similar to treatment with ICS alone administered at
higher doses.
A recent post-hoc analysis of five large clinical trials (>12 000 patients)
comparing budesonide/formoterol single inhaler maintenance and reliever
therapy with other treatments shows it as a highly effective option for patients requiring treatment adjustments across steps two to four in the GINA
treatment guidelines.

Study
This was a 12-week multi-centre open-label therapeutic phase IV study
designed to evaluate the effects of a single inhaler budesonide/formoterol
maintenance and reliever therapy on asthma patients in five countries/areas
across Asia whose asthma condition remained inadequately controlled despite having been on continuous treatment with various asthma therapies,
except budesonide/formoterol, for at least four? eeks.
w

The study was designed to mimic as much as possible routine clinical
practice to minimise interference with physicians’ and patients’ behaviours
that might influence outcomes.
The eligible patient must have demonstrated reversible airway obstrucm
tion, defined as an increase in FEV1 ?12% and 200? l from pre-bronchodilator value. Patients were excluded if they were found to have any of the
following:
• Chronic obstructive pulmonary disease.
• Previous treatment with budesonide/formoterol.
• Current use of any ?–blocker therapy.
• Use of ICS within the 30 days preceding this study enrolment.
• A smoking history of ?10 pack-years.
Additionally, to enter the study treatment period, patient must have experienced no asthma exacerbation during the run-in to treatment.
The primary objective of the study was to compare, at a regional level,
the effects of inhaled budesonide/formoterol maintenance and re