The purpose of this study is to evaluate the superiority of CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of CHF 5993 200/6/12.5 µg pMDI vs CHF 5993 200/6/12.5 µg plus open-label Tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,433
Pre-dose FEV1 (Forced Expiratory Volume in the first second)
Time frame: Week 26
Reduction of moderate and severe asthma exacerbations rate
Time frame: Week 0 to Week 52
Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose
Time frame: Week 26
Change from baseline in morning PEF (Peak Expiratory Flow)
Time frame: Week 0 to Week 26
Reduction of severe asthma exacerbations rate
Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials
Time frame: Week 0 to week 52
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Chiesi Clinical Trial Site 432702
Buenos Aires, Argentina
Chiesi Clinical Trial Site 432704
CABA, Argentina
Chiesi Clinical Trial Site 432705
Mar del Plata, Argentina
Chiesi Clinical Trial Site 432701
Quilmes, Argentina
Chiesi Clinical Trial Site 432703
San Miguel de Tucumán, Argentina
Chiesi Clinical Trial Site 432706
San Miguel de Tucumán, Argentina
Chiesi Clinical Trial Site 112703
Homyel, Belarus
Chiesi Clinical Trial Site 112704
Homyel, Belarus
Chiesi Clinical Trial Site 112701
Minsk, Belarus
Chiesi Clinical Trial Site 112702
Minsk, Belarus
...and 234 more locations