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A phase II, double-blind, placebo-controlled, randomised, 6-way cross-over, single-dose study to investigate the local and systemic effects of 3 doses of inhaled AZD3199 (a β2-agonist) compared to for...

Update Il y a 4 ans
Reference: EUCTR2008-001724-32

A phase II, double-blind, placebo-controlled, randomised, 6-way cross-over, single-dose study to investigate the local and systemic effects of 3 doses of inhaled AZD3199 (a β2-agonist) compared to formoterol in asthmatic patients

Woman and Man

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Extract

The primary objective of the study is to investigate the pharmacodynamics of AZD3199 inhaled via Turbuhaler compared to placebo and inhaled formoterol. The primary variable for local pulmonary effect is Forced Expiratory Volume in 1 second (FEV1) and the primary variable for systemically mediated effect is potassium concentration. Heart rate, QTc, pulse, blood pressure, tremor and palpitations constitute secondary variables for systemically mediated effects.

Inclusion criteria

  • Asthma

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