E. Seberova et A. Andersson, Oxis (R) (formoterol given by Turbuhaler (R)) showed as rapid an onset of action as salbutamol given by a pMDI, RESP MED, 94(6), 2000, pp. 607-611
Thirty-six adult patients (16 women) with mild to moderate asthma with a me
an baseline forced expiratory volume in 1 sec (FEV1) of 73.8% (46-106%) of
predicted normal value and mean reversibility of 24.2% (14.6-47.1%) were in
cluded in this double-blind, double-dummy, randomized, placebo-controlled a
nd cross-over study. The patients inhaled single doses 4.5 or 9 mu g of for
moterol (Oxis(R)) via Turbuhaler(R) salbutamol (Ventolin(R)) 100 or 200 mu
g from a pressurized metered dose inhaler (pMDI) or placebo at five randomi
zed visits. Efficacy was measured by FEV1 pre-dose and then 1, 3, 5, 7, 10,
15, 20, 25 and 30 min after inhalation of the study drug. The primary vari
able of efficacy was the FEV1-value 3 min after dose intake.
No statistically significant differences were found between active treatmen
ts. All active treatments gave a higher bronchodilating effect at 3 min tha
n placebo: 10.0, 11.4% for salbutamol 100 and 200 mu g and 11.7, 11.8% for
formoterol 4.5 and 9 mu g (P < 0.001 in all cases). There was a correlation
between the measured response at 3 min and the subjective experience of th
e patients. The relative difference vs, placebo remained throughout the stu
dy period for all active treatments except for low dose salbutamol. All tre
atments were well tolerated.
In conclusion, formoterol Turbuhaler has as rapid an onset of action as sal
butamol pMDI when given at recommended doses.