A Phase II, multinational, multicentre, double-blind, randomised, active-controlled, 3-way cross-over study to evaluate the therapeutic equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in subjects with mild to moderate asthma. [TRECONY]

Condition studied

Mild to moderate asthma

Investigational medicinal product(s)

Eligibility

Primary endpoint

• Change from baseline in FEV1 AUC0-4h on Day 1 • Change from baseline in pre-dose FEV1 on Day 28

Endpoint detail

Relative and absolute change from pre-dose FEV1 at all post-dose timepoints at each visit, Number and percentage of subjects with a >15% relative decrease from pre-dose in FEV1 at any post-dose timepoint at each visit, Change from pre-dose FEV1 area under the curve from time 0 to 2 h (AUC0-2h) on Day 28, Change from baseline (Day 1) in ACQ-7 scores on Day 28, Average daily use of rescue medication (number of puffs/day), percentage of days without intake of rescue medication and percentage of asthma control days during the TP, Average morning and evening PEF and average daily symptoms during TP