Chronic Obstructive Pulmonary Disease (COPD) is a lung condition
wherein the patient suffers from symptoms of breathlessness, cough and reduced
Drugs that dilate the bronchi
(the branches of the airways) are used to relieve the obstruction and help the
patient to breathe. These drugs may be
short-acting like salbutamol, or long-acting like salmeterol and formoterol.
The effects of formoterol
and placebo in COPD patients were compared in a study recently published in BMC Pulmonary Medicine
aim of the study was to establish the usefulness of the long-acting drug in
COPD as well as to test its safety in COPD patients.
Some prior studies had suggested that
long-acting bronchodilators could increase the risk of death in these patients.
The study was carried out on
a total of 613 patients of European and Japanese origin. Some
patients received 4.5µg of formoterol twice daily, others received a doubled
dose of 9µg of formoterol twice daily, and still others received a placebo (an
inert substance for comparison purpose).
The patients were administered the drug for a total duration of 12
weeks. Lung function was measured using
a spirometer. Patients who needed
additional medication could take the short-acting drug salbutamol whenever
required. They could also continue to
take short-acting anticholinergics as earlier.
At the end of the study period, it was found that the measured lung
function (which was FEV1 60-min post-dose in the study) improved significantly
in both the formoterol groups as compared to placebo
. There was no significant
difference between the two formoterol groups.
The improvement in clinically-relevant quality of life, as measured by
a questionnaire, was significantly higher with formoterol 9µg as compared to
However, there was no
clinically-significant improvement in quality of life with 4.5µg formoterol as
compared to placebo. Both groups on formoterol required less
additional salbutamol treatment as compared to placebo; the group on the higher
dose also required less salbutamol rescue as compared to the lower dose.
Most side effects in patients with formoterol were similar in number as
compared to placebo
. Side effects included
nasopharyngitis (inflammation of the nose and throat), COPD exacerbation, and
bronchitis complication. Two deaths
occurred in the formoterol groups, but they were unrelated to the treatment.
Thus, formoterol is an effective drug in improving COPD at doses of 4.5µg as
well as 9µg twice a day, with the twice daily dose of 9µg providing some
study refutes the conclusions of some earlier studies which state that
formoterol treatment can cause more deaths in COPD patients.
1. Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose
M. Efficacy and safety of inhaled
formoterol 4.5 and 9 μg twice daily in Japanese and European COPD patients:
Phase III study results. BMC Pulmonary
Medicine 2011, 11:51 doi:10.1186/1471-2466-11-51