Elsevier

Respiratory Medicine

Volume 94, Issue 6, June 2000, Pages 607-611
Respiratory Medicine

Regular Article
Oxis®(formoterol given by Turbuhaler®) showed as rapid an onset of action as salbutamol given by a pMDI

https://doi.org/10.1053/rmed.2000.0788Get rights and content
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Abstract

Thirty-six adult patients (16 women) with mild to moderate asthma with a mean 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 included in this double-blind, double-dummy, randomized, placebo-controlled and cross-over study. The patients inhaled single doses 4·5 or 9 μ g of formoterol (Oxis®) via Turbuhaler®salbutamol (Ventolin®) 100 or 200 μ g from a pressurized metered dose inhaler (pMDI) or placebo at five randomized visits. Efficacy was measured by FEV1pre-dose and then 1, 3, 5, 7, 10, 15, 20, 25 and 30 min after inhalation of the study drug. The primary variable of efficacy was the FEV1-value 3 min after dose intake.

No statistically significant differences were found between active treatments. All active treatments gave a higher bronchodilating effect at 3 min than placebo: 10·0, 11·4% for salbutamol 100 and 200 μ g and 11·7, 11·8% for formoterol 4·5 and 9 μ g (P<0·001 in all cases). There was a correlation between the measured response at 3 min and the subjective experience of the patients. The relative difference vs. placebo remained throughout the study period for all active treatments except for low dose salbutamol. All treatments were well tolerated.

In conclusion, formoterol Turbuhaler has as rapid an onset of action as salbutamol pMDI when given at recommended doses.

Keywords

onset
Oxis
formoterol
salbutamol
Turbuhaler
pMDI.

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Correspondence should be addressed to: Dr. A. Andersson, AstraZeneca R&D, Lund, Clinical operations, S-221 87 Lund, Sweden.