A study to evaluate CHF1535 100/6 μg NEXThaler® in adult asthmatics

• Research type

  Research Study

• Full title

  A single dose, randomised, double blind, double dummy, placebo controlled 3-way crossover study comparing the onset of relief from methacholine-induced bronchoconstriction with CHF1535 100/6 μg NEXThaler® versus CHF1535 100/6μg pMDI in asthmatic patients.

• IRAS ID

  217692

• Contact name

  Sara Collarini

• Contact email

  s.collarini@chiesi.com

• Sponsor organisation

  CHIESI FARMACEUTICI S.p.A.

• Eudract number

  2016-003672-47

• Duration of Study in the UK

  0 years, 8 months, 0 days

• Research summary

  The principal aim of the study is to demonstrate that a single dose of CHF 1535\nNEXThaler® 100/6 μg gives relief which is as good and fast as a single dose of CHF 1535 pMDI for asthmatic patients suffering from acute asthma symptoms/signs induced by methacholine challenge test, in terms of lung function.\n

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  16/NW/0831

• Date of REC Opinion

  20 Dec 2016

• REC opinion

  Further Information Favourable Opinion