Trippel vid astma hög styrka kontra Ics/Laba hs och tiotRopium (TRIGGER) (TRIGGER)
EN 52 VECKOR, RANDOMISERAD, DUBBEL BLIND, MULTINATIONELL, MULTICENTRAL, AKTIVT KONTROLLERAD, 3-ARMS PARALLELL GRUPP FÖRSÖK SOM JÄMFÖR CHF 5993 200/6/12,5 µg pMDI (FAST KOMBINATION AV EXTRAFIN BEDICOLIDE TILL 52,5 µg pMDI) /6 µg pMDI (FAST KOMBINATION AV EXTRAFIN BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARAT) ENLIGT ELLER Ovanpå ÖPPEN TIOTROPIUM 2,5 µg RESPIMAT® HOS PATIENTER MED ASTHMA OKOONTROLLERADE OCH 2,5 µg RESPIMAT® I PATIENTER MED ASTHMA OKOTROLLERAD CAMPO- OCH OCH OCH OCH 2.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This was a phase III, multicentre, randomised, double-blind study, with an open-label arm, active-controlled, 3-arm parallel group study to demonstrate both the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose FEV1 at Week 26 and a reduction of moderate and severe asthma exacerbation rate with CHF 5993 pMDI 200/6/12.5 μg compared to CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.
The study was performed in patients with uncontrolled asthma on high doses of inhaled corticosteroids (ICS) in combination with long acting β2-agonists LABAs). The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and all other requirements of local laws.
Patients completed the electronic diary (eDiary)/electronic peak flow meter (ePeakflowmeter) twice daily at home from screening to Week 52, recording asthma symptoms, treatment compliance, rescue intake and peak expiratory flow (PEF). The Asthma Control Questionnaire© (ACQ)-7 was completed at all visits from screening to Week 52. The EuroQuality of Life-5-Dimensional-3-Level (EQ-5D-3L™) questionnaire was completed at all visits from randomisation to Week 52. Health economic information was collected during the study. An independent Data Safety Monitoring Board was established for evaluation of the study and impartial safety assurance for patients. An Adjudication Committee was established to evaluate Major Adverse Cardiovascular Events.
Primary objective of the study were:
- To demonstrate the superiority of CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg in terms of change from baseline in pre-dose forced expiratory volume in the 1st second (FEV1) at Week 26;
- To demonstrate the reduction of moderate and severe asthma exacerbations rate with CHF 5993 pMDI 200/6/12.5 μg compared with CHF 1535 pMDI 200/6 μg during the entire 52-week treatment period.
The secondary endpoints included pooled analyse of 2 pivotal studies; this study (TRIGGER) and study (TRIMARAN). These 2 studies have similar study designs and study population.
CHF 1535 pMDI: fixed-dose combination (FDC) of BDP + FF + GB Dose: BDP 200 μg, FF 6 μg, GB 12.5 μg per actuation, 2 inhalations, BID. Total daily dose: BDP 800 μg, FF 24 μg, GB 50 μg.
BDP: Beclometasone dipropionate FF: Formoterol fumarate GB: Glycopyrronium bromide
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Buenos Aires, Argentina
- Chiesi Clinical Trial Site 432702
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CABA, Argentina
- Chiesi Clinical Trial Site 432704
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Mar del Plata, Argentina
- Chiesi Clinical Trial Site 432705
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Quilmes, Argentina
- Chiesi Clinical Trial Site 432701
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San Miguel de Tucumán, Argentina
- Chiesi Clinical Trial Site 432703
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San Miguel de Tucumán, Argentina
- Chiesi Clinical Trial Site 432706
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Homyel, Belarus
- Chiesi Clinical Trial Site 112703
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Homyel, Belarus
- Chiesi Clinical Trial Site 112704
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Minsk, Belarus
- Chiesi Clinical Trial Site 112701
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Minsk, Belarus
- Chiesi Clinical Trial Site 112702
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Minsk, Belarus
- Chiesi Clinical Trial Site 112705
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Blagoevgrad, Bulgarien
- Chiesi Clinical Trial Site 100707
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Burgas, Bulgarien
- Chiesi Clinical Trial Site 100720
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Gabrovo, Bulgarien
- Chiesi Clinical Trial Site 100718
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Haskovo, Bulgarien
- Chiesi Clinical Trial Site 100713
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Montana, Bulgarien
- Chiesi Clinical Trial Site 100722
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Pleven, Bulgarien
- Chiesi Clinical Trial Site 100702
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Plovdiv, Bulgarien
- Chiesi Clinical Trial Site 100705
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Plovdiv, Bulgarien
- Chiesi Clinical Trial Site 100708
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Plovdiv, Bulgarien
- Chiesi Clinical Trial Site 100715
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Rousse, Bulgarien
- Chiesi Clinical Trial Site 100716
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Sofia, Bulgarien
- Chiesi Clinical Trial Site 100701
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Sofia, Bulgarien
- Chiesi Clinical Trial Site 100703
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Sofia, Bulgarien
- Chiesi Clinical Trial Site 100704
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Sofia, Bulgarien
- Chiesi Clinical Trial Site 100709
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Sofia, Bulgarien
- Chiesi Clinical Trial Site 100719
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Stara Zagora, Bulgarien
- Chiesi Clinical Trial Site 100706
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Stara Zagora, Bulgarien
- Chiesi Clinical Trial Site 100712
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Varna, Bulgarien
- Chiesi Clinical Trial Site 100710
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Vidin, Bulgarien
- Chiesi Clinical Trial Site 100711
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Vidin, Bulgarien
- Chiesi Clinical Trial Site 100721
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Bologna, Italien
- Chiesi Clinical Trial Site 380704
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Catania, Italien
- Chiesi Clinical Trial Site 380703
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Genova, Italien
- Chiesi Clinical Trial Site 380701
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Palermo, Italien
- Chiesi Clinical Trial Site 380705
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Pavia, Italien
- Chiesi Clinical Trial Site 380702
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Tradate, Italien
- Chiesi Clinical Trial Site 380706
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Vilnius, Litauen
- Chiesi Clinical Trial Site 440702
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Vilnius, Litauen
- Chiesi Clinical Trial Site 440703
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Vilnius, Litauen
- Chiesi Clinical Trial Site 440705
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Šiauliai, Litauen
- Chiesi Clinical Trial Site 440701
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Bialystok, Polen
- Chiesi Clinical Trial Site 616713
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Bialystok, Polen
- Chiesi Clinical Trial Site 616718
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Bielsko-Biala, Polen
- Chiesi Clinical Trial Site 616722
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Bienkówka, Polen
- Chiesi Clinical Trial Site 616702
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Bydgoszcz, Polen
- Chiesi Clinical Trial Site 616727
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Giżycko, Polen
- Chiesi Clinical Trial Site 616704
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Grudziądz, Polen
- Chiesi Clinical Trial Site 616716
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Katowice, Polen
- Chiesi Clinical Trial Site 616725
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Katowice, Polen
- Chiesi Clinical Trial Site 616729
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Krakow, Polen
- Chiesi Clinical Trial Site 616719
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Krakow, Polen
- Chiesi Clinical Trial Site 616734
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Krakow, Polen
- Chiesi Clinical Trial Site 616736
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Lodz, Polen
- Chiesi Clinical Trial Site 616707
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Lodz, Polen
- Chiesi Clinical Trial Site 616708
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Lodz, Polen
- Chiesi Clinical Trial Site 616711
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Lodz, Polen
- Chiesi Clinical Trial Site 616726
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Mrozy, Polen
- Chiesi Clinical Trial Site 616733
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Ostróda, Polen
- Chiesi Clinical Trial Site 616717
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Otwock, Polen
- Chiesi Clinical Trial Site 616731
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Pabianice, Polen
- Chiesi Clinical Trial Site 616703
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Poznan, Polen
- Chiesi Clinical Trial Site 616709
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Poznan, Polen
- Chiesi Clinical Trial Site 616728
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Proszowice, Polen
- Chiesi Clinical Trial Site 616720
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Rzeszów, Polen
- Chiesi Clinical Trial Site 616723
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Rzeszów, Polen
- Chiesi Clinical Trial Site 616735
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Skierniewice, Polen
- Chiesi Clinical Trial Site 616721
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Strzelce Opolskie, Polen
- Chiesi Clinical Trial Site 616732
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Tarnów, Polen
- Chiesi Clinical Trial Site 616710
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Warsaw, Polen
- Chiesi Clinical Trial Site 616701
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Wilkowice, Polen
- Chiesi Clinical Trial Site 616730
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Wroclaw, Polen
- Chiesi Clinical Trial Site 616705
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Wroclaw, Polen
- Chiesi Clinical Trial Site 616714
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Wroclaw, Polen
- Chiesi Clinical Trial Site 616715
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Świdnik, Polen
- Chiesi Clinical Trial Site 616712
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Aveiro, Portugal
- Chiesi Clinical Trial Site 620704
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Figueira da Foz Municipality, Portugal
- Chiesi Clinical Trial Site 620703
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Lisbon, Portugal
- Chiesi Clinical Trial Site 620702
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Loures, Portugal
- Chiesi Clinical Trial Site 620708
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Vila Nova de Gaia, Portugal
- Chiesi Clinical Trial Site 620707
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Alexandru cel Bun, Rumänien
- Chiesi Clinical Trial Site 642715
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Arad, Rumänien
- Chiesi Clinical Trial Site 642713
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Bacau, Rumänien
- Chiesi Clinical Trial Site 642722
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Bragadiru, Rumänien
- Chiesi Clinical Trial Site 642717
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Brasov, Rumänien
- Chiesi Clinical Trial Site 642706
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Bucharest, Rumänien
- Chiesi Clinical Trial Site 642703
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Bucharest, Rumänien
- Chiesi Clinical Trial Site 642707
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Bucharest, Rumänien
- Chiesi Clinical Trial Site 642708
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Bucharest, Rumänien
- Chiesi Clinical Trial Site 642719
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Bucharest, Rumänien
- Chiesi Clinical Trial Site 642723
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Cluj-Napoca, Rumänien
- Chiesi Clinical Trial Site 642709
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Cluj-Napoca, Rumänien
- Chiesi Clinical Trial Site 642714
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Cluj-Napoca, Rumänien
- Chiesi Clinical Trial Site 642716
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Cluj-Napoca, Rumänien
- Chiesi Clinical Trial Site 642718
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Cluj-Napoca, Rumänien
- Chiesi Clinical Trial Site 642726
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Craiova, Rumänien
- Chiesi Clinical Trial Site 642712
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Iași, Rumänien
- Chiesi Clinical Trial Site 642704
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Iași, Rumänien
- Chiesi Clinical Trial Site 642710
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Oradea, Rumänien
- Chiesi Clinical Trial Site 642705
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Suceava, Rumänien
- Chiesi Clinical Trial Site 642711
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Timișoara, Rumänien
- Chiesi Clinical Trial Site 642721
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Chelyabinsk, Ryssland
- Chiesi Clinical Trial Site 643727
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Chelyabinsk, Ryssland
- Chiesi Clinical Trial Site 643733
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Chelyabinsk, Ryssland
- Chiesi Clinical Trial Site 643745
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Izhevsk, Ryssland
- Chiesi Clinical Trial Site 643754
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Kazan', Ryssland
- Chiesi Clinical Trial Site 643713
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Kazan', Ryssland
- Chiesi Clinical Trial Site 643719
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Kazan', Ryssland
- Chiesi Clinical Trial Site 643741
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Kazan', Ryssland
- Chiesi Clinical Trial Site 643746
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Kemerovo, Ryssland
- Chiesi Clinical Trial Site 643704
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Kemerovo, Ryssland
- Chiesi Clinical Trial Site 643731
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Moscow, Ryssland
- Chiesi Clinical Trial Site 643702
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Moscow, Ryssland
- Chiesi Clinical Trial Site 643705
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Moscow, Ryssland
- Chiesi Clinical Trial Site 643706
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Moscow, Ryssland
- Chiesi Clinical Trial Site 643718
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Moscow, Ryssland
- Chiesi Clinical Trial Site 643722
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Moscow, Ryssland
- Chiesi Clinical Trial Site 643735
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Moscow, Ryssland
- Chiesi Clinical Trial Site 643743
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Nizhny Novgorod, Ryssland
- Chiesi Clinical Trial Site 643707
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Nizhny Novgorod, Ryssland
- Chiesi Clinical Trial Site 643723
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Nizhny Novgorod, Ryssland
- Chiesi Clinical Trial Site 643744
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Novosibirsk, Ryssland
- Chiesi Clinical Trial Site 643717
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Odintsovo, Ryssland
- Chiesi Clinical Trial Site 643724
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Orenburg, Ryssland
- Chiesi Clinical Trial Site 643729
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Pyatigorsk, Ryssland
- Chiesi Clinical Trial Site 643711
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Ryazan, Ryssland
- Chiesi Clinical Trial Site 643701
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643712
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643714
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643715
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643716
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643725
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643730
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643732
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643737
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643739
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643752
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643757
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Saint Petersburg, Ryssland
- Chiesi Clinical Trial Site 643758
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Saratov, Ryssland
- Chiesi Clinical Trial Site 643703
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Saratov, Ryssland
- Chiesi Clinical Trial Site 643736
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Smolensk, Ryssland
- Chiesi Clinical Trial Site 643726
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Stavropol, Ryssland
- Chiesi Clinical Trial Site 643740
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Tomsk, Ryssland
- Chiesi Clinical Trial Site 643709
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Tomsk, Ryssland
- Chiesi Clinical Trial Site 643728
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Tomsk, Ryssland
- Chiesi Clinical Trial Site 643759
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Ufa, Ryssland
- Chiesi Clinical Trial Site 643755
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Vladikavkaz, Ryssland
- Chiesi Clinical Trial Site 643708
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Vladimir, Ryssland
- Chiesi Clinical Trial Site 643738
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Voronezh, Ryssland
- Chiesi Clinical Trial Site 643710
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Yaroslavl, Ryssland
- Chiesi Clinical Trial Site 643720
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Yaroslavl, Ryssland
- Chiesi Clinical Trial Site 643734
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Yaroslavl, Ryssland
- Chiesi Clinical Trial Site 643742
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Yaroslavl, Ryssland
- Chiesi Clinical Trial Site 643749
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Yekaterinburg, Ryssland
- Chiesi Clinical Trial Site 643721
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Bratislava, Slovakien
- Chiesi Clinical Trial Site 703704
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Bratislava, Slovakien
- Chiesi Clinical Trial Site 703707
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Ilava, Slovakien
- Chiesi Clinical Trial Site 703702
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Košice, Slovakien
- Chiesi Clinical Trial Site 703705
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Košice, Slovakien
- Chiesi Clinical Trial Site 703706
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Nové Zámky, Slovakien
- Chiesi Clinical Trial Site 703701
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Prievidza, Slovakien
- Chiesi Clinical Trial Site 703709
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Spišská Nová Ves, Slovakien
- Chiesi Clinical Trial Site 703703
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Štúrovo, Slovakien
- Chiesi Clinical Trial Site 703708
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A Coruña, Spanien
- Chiesi Clinical Trial Site 724702
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Badajoz, Spanien
- Chiesi Clinical Trial Site 724703
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Badalona, Spanien
- Chiesi Clinical Trial Site 724706
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Madrid, Spanien
- Chiesi Clinical Trial Site 724701
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Madrid, Spanien
- Chiesi Clinical Trial Site 724704
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Málaga, Spanien
- Chiesi Clinical Trial Site 724705
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Sabadell, Spanien
- Chiesi Clinical Trial Site 724707
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Llanelli, Storbritannien
- Chiesi Clinical Trial Site 826702
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London, Storbritannien
- Chiesi Clinical Trial Site 826703
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Manchester, Storbritannien
- Chiesi Clinical Trial Site 826704
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Soham, Storbritannien
- Chiesi Clinical Trial Site 826701
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Blansko, Tjeckien
- Chiesi Clinical Trial Site 203711
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Brandýs nad Labem, Tjeckien
- Chiesi Clinical Trial Site 203702
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Brno, Tjeckien
- Chiesi Clinical Trial Site 203708
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Jindřichův Hradec, Tjeckien
- Chiesi Clinical Trial Site 203707
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Kralupy nad Vltavou, Tjeckien
- Chiesi Clinical Trial Site 203705
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Miroslav, Tjeckien
- Chiesi Clinical Trial Site 203709
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Opava, Tjeckien
- Chiesi Clinical Trial Site 203704
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Prague, Tjeckien
- Chiesi Clinical Trial Site 203701
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Prague, Tjeckien
- Chiesi Clinical Trial Site 203703
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Prague, Tjeckien
- Chiesi Clinical Trial Site 203710
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Rokycany, Tjeckien
- Chiesi Clinical Trial Site 203713
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Teplice, Tjeckien
- Chiesi Clinical Trial Site 203706
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Varnsdorf, Tjeckien
- Chiesi Clinical Trial Site 203712
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Ankara, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792701
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Ankara, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792702
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Antalya, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792703
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Aydin, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792710
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Istanbul, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792707
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Kocaeli, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792706
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Maltepe, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792705
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Mersin, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792708
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Yenişehir, Turkiet (Türkiye)
- Chiesi Clinical Trial Site 792709
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Berlin, Tyskland
- Chiesi Clinical Trial Site 276709
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Berlin, Tyskland
- Chiesi Clinical Trial Site 276712
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Bonn, Tyskland
- Chiesi Clinical Trial Site 276711
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Frankfurt am Main, Tyskland
- Chiesi Clinical Trial Site 276707
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Frankfurt am Main, Tyskland
- Chiesi Clinical Trial Site 276714
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Hamburg, Tyskland
- Chiesi Clinical Trial Site 276705
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Hanover, Tyskland
- Chiesi Clinical Trial Site 276703
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Koblenz, Tyskland
- Chiesi Clinical Trial Site 276708
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Leipzig, Tyskland
- Chiesi Clinical Trial Site 276702
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Leipzig, Tyskland
- Chiesi Clinical Trial Site 276704
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Leipzig, Tyskland
- Chiesi Clinical Trial Site 276710
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Mainz, Tyskland
- Chiesi Clinical Trial Site 276715
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München, Tyskland
- Chiesi Clinical Trial Site 276701
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Münster, Tyskland
- Chiesi Clinical Trial Site 276713
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Rosenheim, Tyskland
- Chiesi Clinical Trial Site 276716
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Dnipro, Ukraina
- Chiesi Clinical Trial Site 804701
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Ivano-Frankivsk, Ukraina
- Chiesi Clinical Trial Site 804711
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Kharkiv, Ukraina
- Chiesi Clinical Trial Site 804709
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Kherson, Ukraina
- Chiesi Clinical Trial Site 804710
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Kiev, Ukraina
- Chiesi Clinical Trial Site 804713
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Kyiv, Ukraina
- Chiesi Clinical Trial Site 804705
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Lviv, Ukraina
- Chiesi Clinical Trial Site 804712
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Sumy, Ukraina
- Chiesi Clinical Trial Site 804715
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Vinnytsia, Ukraina
- Chiesi Clinical Trial Site 804703
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Vinnytsia, Ukraina
- Chiesi Clinical Trial Site 804706
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Vinnytsia, Ukraina
- Chiesi Clinical Trial Site 804707
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Vinnytsia, Ukraina
- Chiesi Clinical Trial Site 804714
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Zaporizhzhya, Ukraina
- Chiesi Clinical Trial Site 804704
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Zhytomyr, Ukraina
- Chiesi Clinical Trial Site 804708
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Balassagyarmat, Ungern
- Chiesi Clinical Trial Site 348707
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Budapest, Ungern
- Chiesi Clinical Trial Site 348715
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Debrecen, Ungern
- Chiesi Clinical Trial Site 348721
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Gödöllő, Ungern
- Chiesi Clinical Trial Site 348712
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Hatvan, Ungern
- Chiesi Clinical Trial Site 348718
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Komárom, Ungern
- Chiesi Clinical Trial Site 348717
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Létavértes, Ungern
- Chiesi Clinical Trial Site 348709
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Monor, Ungern
- Chiesi Clinical Trial Site 348703
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Mórahalom, Ungern
- Chiesi Clinical Trial Site 348719
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Nyíregyháza, Ungern
- Chiesi Clinical Trial Site 348704
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Nyíregyháza, Ungern
- Chiesi Clinical Trial Site 348714
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Pécs, Ungern
- Chiesi Clinical Trial Site 348713
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Pécs, Ungern
- Chiesi Clinical Trial Site 348720
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Siófok, Ungern
- Chiesi Clinical Trial Site 348702
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Szarvas, Ungern
- Chiesi Clinical Trial Site 348706
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Szeged, Ungern
- Chiesi Clinical Trial Site 348701
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Szombathely, Ungern
- Chiesi Clinical Trial Site 348705
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Vásárosnamény, Ungern
- Chiesi Clinical Trial Site 348710
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Érd, Ungern
- Chiesi Clinical Trial Site 348708
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Anamnes med astma ≥ 1 år och diagnostiserad före 40 års ålder
- Okontrollerad astma med dubbelbehandling endast på höga doser av inhalerad CorticoSteroid (ICS) i kombination med långverkande beta2-agonist (LABA) med ACQ-7 (Astmakontrollfrågeformulär) ≥1,5
- Pre-bronkdilaterande FEV1 <80 % av det förväntade normalvärdet
- Positivt reversibilitetstest
- Minst 1 dokumenterad astmaexacerbation under föregående år
Exklusions kriterier:
- Gravida eller ammande kvinnor
- Diagnos av kronisk obstruktiv lungsjukdom (KOL)
- Patienter med någon astmaexacerbation eller luftvägsinfektion under de fyra veckorna före screening
- Aktuell rökare eller före detta rökare (>= 10 förpackningar år)
- Varje förändring i dos, schema eller formulering av kombinationen ICS + LABA under de 4 veckorna före screening
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: CHF 5993 200/6/12,5 µg
Behandling A: CHF 5993 200/6/12,5 µg: 2 inhalationer bid Total daglig dos: 800/24/50 µg BDP/FF/GB |
|
|
Aktiv komparator: CHF 1535 200/6 µg
Behandling B: CHF 1535 200/6 µg: 2 inhalationer bid Total daglig dos: 800/24 µg BDP/FF |
|
|
Aktiv komparator: CHF 1535 200/6 µg + Tiotropium Respimat 2,5 µg
Behandling C (öppen arm): CHF 1535 200/6 µg: 2 inhalationer bud + Tiotropium Respimat 2,5 µg: 2 inhalationer od Total daglig dos: 800/24 µg BDP/FF + 5 µg Tio |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26
Tidsram: Week 0 (pre-treatment, baseline) to Week 26.
|
Change from baseline in pre-dose FEV1, analysed at Week 26 of treatment. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 26.
|
|
2_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Asthma exacerbation intensity: Moderate AND Severe Asthma Exacerbation Severe: asthma worsening requiring initiation of treatment with systemic corticosteroids for at least 3 days (courses of corticosteroids separated by ≥1 week treated as separate severe exacerbations). Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:
|
Week 0 (pre-treatment, baseline) to Week 52.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
3_Change From Baseline in Peak(0-3h) FEV1 at Week 26
Tidsram: Week 0 (pre-treatment, baseline) and Week 26.
|
Peak peak of forced expiratory volume in the first second (FEV1) within 3 hours post-dose. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) and Week 26.
|
|
4_Change From Baseline in Morning Peak Expiratory Flow (PEF) Over the 26-Week Treatment
Tidsram: Week 0 (pre-treatment, baseline) to Week 26.
|
Change from baseline in the average morning PEF (Litre/min), measured by patients at home over the 26-week treatment period (i.e., up to Week 26). PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26.
|
|
5_Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period - Pooled Analysis
Tidsram: The entire treatment period; up to Week 52.
|
Severe asthma exacerbation rate over the 52-Week treatment period in a pre-specified pooled analysis of 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
The entire treatment period; up to Week 52.
|
|
6_Change From Baseline in Peak FEV1 (0-3h) at All Clinical Visits
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
The peak (0-3h) FEV1 at baseline and at all subsequent visits, and the respective changes from baseline are presented by treatment group for all clinical visits. Baseline for pre-dose FEV1 was calculated as average of the FEV1 measurements (L) from the visit 2 (V2) Pre45min & V2 Pre15min. If one of the two pre-dose values was missing, the baseline was equal to the available pre-dose value. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
7_Change From Baseline in Pre-Dose FEV1 at All Clinical Visits
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Results show the change from baseline in pre-dose FEV1 at all clinical visits. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
8_FEV1 Response (FEV1 ≥ 100 mL) at Week 26 and Week 52
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Results show the percentage of patients classified as FEV1 responders at Week 26 and at Week 52. The FEV1 response was defined as: Change from baseline in pre-dose morning FEV1 ≥ 100 mL. FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
9_Change From Baseline in FEV1 Area Under the Curve (AUC) (0-3h) Normalised by Time at All Clinical Visits
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Baseline definition: mean of two pre-dose FEV1 measurements at visit 2 (V2). Results show the change from baseline in FEV1 area under the curve [AUC] (0-3h) at all subsequent visits (i.e. change from baseline of the AUC of the serial post-dose spirometry assessments till 3h post-dose). FEV1=Forced expiratory volume in the first second |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
10_Change From Baseline in the Asthma Control Questionnaire-7 (ACQ-7) Score at All Clinical Visits
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
ACQ-7 Questionnaire. ACQ-7 allows assessment of asthma control in individual patients. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue medication use and 1 on lung function (FEV1 % predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control (no impairment) and 6 indicating poor control (maximum impairment). The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question was completed by the study investigator using data from the Master Scope spirometer. Baseline for ACQ-7 was the total score recorded at Visit 2 (Week 0) of the study. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. A negative change from baseline indicates improvement in lung function. |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
11_Asthma Control Questionnaire©-7 Response at Week 26 and Week 52
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Asthma Control Questionnaire (ACQ) and Asthma Control Questionnaire-7 (QAC-7) are defined in the description of Outcome measure 10 above. An ACQ-7 response was defined as change from baseline (Week 0, pre-dose) in ACQ-7 score ≤ -0.5; non-response was defined as change from baseline in ACQ-7 score >-0.5 or missing data. Results represent responders (i.e. change from baseline in ACQ-7 Score ≤ -0.5) at Week 26 and at Week 52. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
12_Change From Baseline in Average Morning PEF (L/Min) Over 52 Weeks of Treatment
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Change from baseline in average MORNING PEF (L/min) over 52 weeks of treatment. PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
12a_Change From Baseline in Average Evening PEF (L/Min) Over 26 and 52 Weeks of Treatment
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Change from baseline in average EVENING PEF (L/min) over 26 and 52 weeks of treatment. PEF=Peak Expiratory Flow; is the maximal airflow forcefully expelled from the lungs in one quick exhalation. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
13_Number of Patients at Risk of Moderate or Severe Asthma Exacerbation Over 52 Weeks
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Number of patients at risk of a moderate or severe asthma exacerbation. Results show the number of patients who had moderate or severe asthma exacerbation over the 52 weeks treatment period. |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
14_Number of Patients at Risk of Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Tidsram: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Number of patients at risk of a SEVERE asthma exacerbation in the pooled analysis of the two pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER), over the 52 weeks treatment period. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
|
15_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02.
Tidsram: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
MODERATE asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-055993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
|
16_Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Tidsram: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Number of Patients at Risk of MODERATE Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02. The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
|
17_Moderate and Severe Asthma Exacerbation Rate Over the 52-Week Treatment Period in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 and CCD-055993AB2-02
Tidsram: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Moderate AND severe asthma exacerbation rate over the 52-Week treatment period in the pooled analysis of the 2 pivotal studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
|
18_Number of Patients at Risk of Moderate OR Severe Asthma Exacerbation in the Pooled Analysis of the Two Pivotal Studies CCD-05993AB1-03 and CCD-05993AB2-02
Tidsram: Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
Time to first MODERATE OR SEVERE asthma exacerbation in the Pooled Analysis of the 2 Pivotal Studies CCD-05993AB1-03 (TRIMARAN) and CCD-05993AB2-02 (TRIGGER). The pooled analysis of pivotal studies TRIMARAN and TRIGGER was a pre-specified secondary outcome measure for this study. Both studies have identical design, duration, endpoints, data collection, and statistical methodology for analyses. TRIMARAN and TRIGGER enrolled patients under medium dose and high dose ICS/LABA, respectively. Both studies were designed to assess the effect of the LAMA on ICS/LABA and showed homogeneity in terms of baseline characteristics, thus confirming the appropriateness of the pooling. |
Week 0 (Baseline) to 52 weeks for both studies in the pooled analysis.
|
|
19_Moderate Asthma Exacerbation Rate Over the 52-Week Treatment Period
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
MODERATE asthma exacerbation rate over the 52-Week treatment period. Asthma exacerbation intensity: Moderate: ≥1 of the following criteria fulfilled and leading to a change in treatment (sustained increase of ≥1 puff of short acting beta 2-agonist [SABA] for 2 consecutive days) as shown below:
|
Week 0 (pre-treatment, baseline) to Week 52.
|
|
20_Number of Patients at Risk of a MODERATE Asthma Exacerbation
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Data were analysed for the number of patients at risk of a MODERATE asthma exacerbation.
|
Week 0 (pre-treatment, baseline) to Week 52.
|
|
21_Change From Baseline in the Average Use of Rescue Medication Over the 26- and 52-Week Treatment Periods
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Change from baseline in the average use of rescue medication over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
21a_Change From Baseline in the Average Use of Rescue Medication in Each Inter-Visit Period
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Results show the change from baseline in the average use (puffs/day) of rescue medication in each inter-visit period. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
22_Change From Baseline in the Percentage of Rescue Medication-Free Days Over the 26- and 52-Week Treatment Periods
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Change from baseline in the percentage of rescue medication-free days over the 26- and 52-Week treatment periods. Data was collected using an electronic daily diary, from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
22a_Change From Baseline in the Percentage of Rescue Medication-Free Days in Each Inter-Visit Period Over the Treatment
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Results show the change from baseline in the percentage of rescue medication-free days in each inter-visit period over the entire treatment. Data was collected through an electronic daily diary from screening to the end of the study. |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
23_Change From Baseline in the Average Total Daily Asthma Symptom Scores Over the 26- and 52-Week Treatment Periods
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness. Morning (night-time asthma symptom score):
Evening (daytime asthma symptom score):
|
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
23a_Change From Baseline in the Average Daily Asthma Symptom Scores in Each Inter-Visit Period
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Results show the change from baseline in the average total daily asthma symptom scores over the 26- and 52-Weeks of treatment. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered: cough, wheeze, chest tightness, breathlessness. Morning (night-time asthma symptom score):
Evening (daytime asthma symptom score):
|
Week 0 (pre-treatment, baseline) to Week 52.
|
|
24_Change From Baseline in the Percentage of Asthma Symptom-Free Days Over the 26- and 52-Week Treatment Periods
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Change from baseline in the percentage of asthma symptom-free days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Results show the change from baseline in the average daily asthma symptom scores over the 26- and 52-Week treatment periods. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
24a_Change From Baseline in the Percentage of Asthma Symptom-Free Days in Each Inter-Visit Periods
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
Results show the change from baseline in the percentage of asthma symptom-free days in each inter-visit periods over the entire treatment. Data was collected through an electronic daily diary from screening to end of the study. A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Symptoms considered by the questionnaire: cough, wheeze, chest tightness, breathlessness. An asthma symptom-free day is a day with total daily asthma symptom score = 0. For a description of the score see outcome measure number 23. |
Week 0 (pre-treatment, baseline) to Week 52.
|
|
25_Change From Baseline in the Percentage of Asthma Control Days Over the 26- and 52-Week Treatment Periods
Tidsram: Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
Results show the change from baseline in the percentage of asthma control days over the 26- and 52-Week treatment periods. Data was collected through an electronic daily diary from screening to the end of the study. Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 26 and Week 52.
|
|
25a_Change From Baseline in the Percentage of Asthma Control Days in Each Inter-Visit Period
Tidsram: Week 0 (pre-treatment, baseline) to Week 52.
|
A day represents data recorded in the evening session of that day plus the data recorded in the morning session of the next day. Data was collected through an electronic daily diary from screening to the end of the study. Scoring of asthma symptoms (overall symptoms, cough, wheeze, chest tightness and breathlessness): Morning (night-time asthma symptoms): 0 (no symptoms), 1 (mild - symptoms not causing awakening), 2 (moderate - discomfort enough to cause awakenings) and 3 (severe - causing awakenings for most of the night/did not sleep at all). Evening (daytime asthma symptoms): 0 (no symptoms), 1 (mild: aware of symptoms that could be easily tolerated), 2 (moderate: discomfort enough to cause interference with daily activity), 3 (severe: incapacitating with inability to work/ take part in usual activity). |
Week 0 (pre-treatment, baseline) to Week 52.
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Biverkningar och biverkningar av läkemedel
Tidsram: Fram till vecka 52
|
Fram till vecka 52
|
|
|
Samling av hälsoekonomiska resultat
Tidsram: Vecka 0 till Vecka 52
|
Total användning av vårdens resurser och frånvaro från arbetet
|
Vecka 0 till Vecka 52
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Georgio Walter Canonica, MD, University of Medicine, Genoa, Italy
Publikationer och användbara länkar
Allmänna publikationer
- Virchow JC, Kuna P, Paggiaro P, Papi A, Singh D, Corre S, Zuccaro F, Vele A, Kots M, Georges G, Petruzzelli S, Canonica GW. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019 Nov 9;394(10210):1737-1749. doi: 10.1016/S0140-6736(19)32215-9. Epub 2019 Sep 30.
- Orlovic M, Magni T, Lukyanov V, Guerra I, Madoni A. Cost-effectiveness of single-inhaler extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium in patients with uncontrolled asthma in England. Respir Med. 2022 Sep;201:106934. doi: 10.1016/j.rmed.2022.106934. Epub 2022 Jul 19.
- Papi A, Singh D, Virchow JC, Canonica GW, Vele A, Georges G. Normalisation of airflow limitation in asthma: Post-hoc analyses of TRIMARAN and TRIGGER. Clin Transl Allergy. 2022 Apr 17;12(4):e12145. doi: 10.1002/clt2.12145. eCollection 2022 Apr.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Determinants of response to inhaled extrafine triple therapy in asthma: analyses of TRIMARAN and TRIGGER. Respir Res. 2020 Oct 29;21(1):285. doi: 10.1186/s12931-020-01558-y.
- Singh D, Virchow JC, Canonica GW, Vele A, Kots M, Georges G, Papi A. Extrafine triple therapy in patients with asthma and persistent airflow limitation. Eur Respir J. 2020 Sep 24;56(3):2000476. doi: 10.1183/13993003.00476-2020. Print 2020 Sep. No abstract available.
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Användbara länkar
- Study Record on EU Clinical Trials Register including results. Study CCD-05993AB2-02; TRIGGER;
- Study Record on EU Clinical Trials Register including results. Study CCD-05993AB1-03; TRIMARAN
- TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA (TRIMARAN) ClinicalTrials.gov ID NCT02676076
- TRIple in Asthma hiGh strenGth vErsus Ics/ Laba hs and tiotRopium (TRIGGER)
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Bronkialsjukdomar
- Lungsjukdomar, obstruktiv
- Respiratorisk överkänslighet
- Överkänslighet, Omedelbar
- Överkänslighet
- Astma
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Parasympatholytika
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Kolinerga antagonister
- Kolinerga medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Tiotropiumbromid
Andra studie-ID-nummer
- CCD-05993AB2-02
- 2015-000717-40 (EudraCT-nummer)
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