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Clinical study to test that the drug CHF 1535 100/6 (fixed combination of an anti-inflammatory drug and relaxing airways drug) delivered via pressurized inhaler using or not a spacer device is as eff...

Update Il y a 4 ans
Reference: EUCTR2011-005108-14

Clinical study to test that the drug CHF 1535 100/6 (fixed combination of an anti-inflammatory drug and relaxing airways drug) delivered via pressurized inhaler using or not a spacer device is as effective in adolescent population as the licensed free combination of the same substances and compare it with administration in adults

Woman and Man

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Extract

To evaluate, in adolescents, the systemic exposure to B17MP (active metabolite of BDP) as AUC0-t, after inhalation of CHF 1535 100/6 pMDI with and without spacer device (AeroChamber Plus™) in comparison with the already licensed free combination of BDP pMDI and formoterol pMDI without spacer.

Inclusion criteria

  • Asthma

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