A randomised, double-blind, placebo-controlled study to evaluate the role of formoterol in the management of acute asthma.
OBJECTIVE
To evaluate the efficacy and tolerability of formoterol delivered by Aerolizer in the emergency department.


METHODS
A single-centre, double-blind, randomised, placebo-controlled, parallel group study was conducted in patients seeking emergent care for an acute exacerbation of asthma. Patients were randomly assigned to one of two groups: group 1 (salbutamol), receiving a total dose of 600 microg salbutamol (200+200+200) delivered by a meter-dose inhaler into a spacer device as two puffs at 20 min intervals; and group 2 (formoterol), receiving formoterol 24 microg (12+12) as two dry powder capsules each containing 12 microg of formoterol via Aerolizer at 20 min intervals. The peak expiratory flow rate (PEFR) was measured at baseline and 5 min after the second and third doses.


RESULTS
60 subjects receiving salbutamol (n = 28) or formoterol (n = 32) completed the study. Age, gender, baseline PEFR, duration of asthma and previous medication were balanced between the two groups. Mean PEFR increased significantly over baseline values in both the salbutamol and formoterol groups (63% in the salbutamol group, p = 0.001, and 55% in the formoterol group, p = 0.001). No significant difference was observed in the increase in PEFR between the groups (p = 0.99, 95% CI -29.62 to 29.59). The proportion of patients reporting adverse events was similar in the two groups.


CONCLUSIONS
Formoterol was found to be well tolerated and as effective as salbutamol in the management of acute asthma. Further studies are needed to follow the patients after discharge from the emergency room to compare the long-term effect of formoterol on patients' stability.
Najafizadeh
Katayoon
K
Department of Pulmonary Medicine, National Research Institute of Tuberculosis and Lung Diseases, Tehran, Iran. katynajafi@nritld.ac.ir
Sohrab Pour
Hamid
H
Ghadyanee
Mojtaba
M
Shiehmorteza
Masoud
M
Jamali
Masoud
M
Majdzadeh
Sayeed
S
D000208:Acute Disease; D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage / Q000009:adverse effects; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D016896:Treatment Outcome; D014987:Xerostomia / Q000139:chemically induced
D001993:Bronchodilator Agents; D004983:Ethanolamines; D000420:Albuterol; D000068759:Formoterol Fumarate