Source: Annual Congress 2001 - Long-acting β2-agonists: clinical effects
Disease area: Airway diseases

Abstract

Aim: To study if a cumulative dose reversibility test (CRT) used as inclusion criteria increases the power of a dose-response study finding equipotent doses of formoterol (F) and terbutaline (T). Design: Two double-blind, crossover, placebo-controlled, dose-response studies (with different reversibility inclusion criteria) were performed in parallel with 4.5, 9 and 18 μg F (Oxis®) Turbuhaler® and 0.5 mg T Turbuhaler. Patients were randomised to a CRT (3 doses salbutamol (S) at 30-minute intervals, requiring increase of ³10% after 1^st and another ³10% after 2^nd or 3^rd dose in FEV₁) or a single dose reversibility test (ST) with S (>15% increase). Results: Sixty asthmatic patients (FEV₁ 69% PN, 88% on inhaled steroids, reversibility 56%) passed the reversibility tests (CRT: 51%, ST: 62%) and were included in the dose-response studies. Hence, the CRT did not make it more difficult to include patients than the ST. The equibronchodilating dose to T 0.5 mg regarding maximal FEV ₁ was F 3.9 μg. The slope of the dose-response curve for maximal FEV ₁ and the variability were similar for the two groups so no advantage for CRT was shown. Conclusion: The CRT did not improve the power in the dose-response study compared with the ST. F 3.9 μg is bronchoequipotent to T 0.5 mg regarding maximal FEV ₁.

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P. Arvidsson, P. Jemsby, J. Ziegler, E. Millinger, M. Perpiña, H. Verea, P. Larsson, Y. Gnosspelius (Gothenburg, Varberg, Eksjo, Linkoping, Lund, Sweden; Valencia, La Coruna, Spain). Will a cumulative dose reversibility test increase the power in a dose-response study comparing formoterol and terbutaline?. Eur Respir J 2001; 16: Suppl. 31, 3472

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