The clinical trial is designed to evaluate 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 (i.e. change in Forced Expiratory Volume in the 1st second, FEV1, from baseline to 5 min after study drug intake) in asthmatic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
University of Dundee
Dundee, United Kingdom
Hammersmith Medicines Research
London, United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom
Change in FEV1 5-min post-dose
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
Time frame: 5 min post-dose
Change in FEV1 other time points
Change in FEV1 from baseline (baseline is the post-diluent value, before methacholine challenge test)
Time frame: Up to 30 min post-dose
FEV1 AUC0-10min
FEV1 area under the curve from dosing to 10 min post-dose
Time frame: From dosing to 10 min post-dose
Time to recovery in FEV1
Time to return to 85% of baseline value
Time frame: From dosing to 30 min post-dose
Change in Borg scale
Change in Borg scale from the end of the methacholine challenge test
Time frame: Up to 30 min post-dose
Time to recovery in Borg scale
50% decrease from the post-methacholine challenge value
Time frame: Up to 30 min post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.