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A clinical trial to investigate the comparability of relief from methacholine-induced bronchoconstriction with CHF1535 100/6 μg NEXThaler® versus CHF1535 100/6 μg pMDI in asthmatic patients

Update Il y a 4 ans
Reference: EUCTR2016-003672-47

Woman and Man

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Extract

To demonstrate the non-inferiority of CHF1535 100/6 μg NEXThaler® versus CHF1535 100/6 μg pMDI on the onset of relief from methacholine-induced bronchospasm, in terms of pulmonary function [change in FEV1 (L) from baseline, i.e. post-diluent, to 5 min after study drug inhalation] in asthmatic patients on low-medium doses of ICS or ICS plus LABA fixed or free combination.

Inclusion criteria

  • Asthma

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