TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
- Conditions
- Asthma
- Interventions
- Drug: CHF 1535 200/6 µgDrug: CHF 5993 200/6/12.5 µgDrug: CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
- Registration Number
- NCT02676089
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1433
- History of asthma ≥ 1 year and diagnosed before 40 years old
- Uncontrolled asthma with double therapy only on high doses of Inhaled CorticoSteroid (ICS) in combination with Long-Acting Beta2 Agonist (LABA) with ACQ-7 (Asthma Control Questionnaire) ≥1.5
- Pre-bronchodilator FEV1 <80% of the predicted normal value
- Positive reversibility test
- At least 1 documented asthma exacerbation in the previous year
- Pregnant or lactating women
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening
- Current smoker or ex-smoker (>= 10 packs year)
- Any change in dose, schedule or formulation of ICS + LABA combination in the 4 weeks prior screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHF 1535 200/6 µg CHF 1535 200/6 µg Treatment B: CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF CHF 5993 200/6/12.5 µg CHF 5993 200/6/12.5 µg Treatment A: CHF 5993 200/6/12.5 µg: 2 inhalations bid Total daily dose: 800/24/50 µg BDP/FF/GB CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg Treatment C (open-label arm): CHF 1535 200/6 µg: 2 inhalations bid + Tiotropium Respimat 2.5 µg: 2 inhalations od Total daily dose: 800/24 µg BDP/FF + 5 µg Tio
- Primary Outcome Measures
Name Time Method Reduction of moderate and severe asthma exacerbations rate Week 0 to Week 52 Pre-dose FEV1 (Forced Expiratory Volume in the first second) Week 26
- Secondary Outcome Measures
Name Time Method Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose Week 26 Reduction of severe asthma exacerbations rate Week 0 to week 52 Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials
Change from baseline in morning PEF (Peak Expiratory Flow) Week 0 to Week 26
Trial Locations
- Locations (244)
Chiesi Clinical Trial Site 432702
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Chiesi Clinical Trial Site 724703
🇪🇸Badajoz, Spain
Chiesi Clinical Trial Site 432705
🇦🇷Mar Del Plata, Argentina
Chiesi Clinical Trial Site 112702
🇧🇾Minsk, Belarus
Chiesi Clinical Trial Site 432704
🇦🇷Caba, Argentina
Chiesi Clinical Trial Site 432701
🇦🇷Quilmes, Argentina
Chiesi Clinical Trial Site 203710
🇨🇿Praha, Czechia
Chiesi Clinical Trial Site 276714
🇩🇪Frankfurt am Main, Germany
Chiesi Clinical Trial Site 203701
🇨🇿Praha, Czechia
Chiesi Clinical Trial Site 380701
🇮🇹Genova, Italy
Chiesi Clinical Trial Site 276707
🇩🇪Frankfurt am Main, Germany
Chiesi Clinical Trial Site 432706
🇦🇷Tucuman, Argentina
Chiesi Clinical Trial Site 100718
🇧🇬Gabrovo, Bulgaria
Chiesi Clinical Trial Site 348703
🇭🇺Monor, Hungary
Chiesi Clinical Trial Site 100703
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 100704
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 432703
🇦🇷San Miguel de Tucumán, Argentina
Chiesi Clinical Trial Site 203705
🇨🇿Kralupy Nad Vltavou, Czechia
Chiesi Clinical Trial Site 348702
🇭🇺Siófok, Hungary
Chiesi Clinical Trial Site 100705
🇧🇬Plovdiv, Bulgaria
Chiesi Clinical Trial Site 348707
🇭🇺Balassagyarmat, Hungary
Chiesi Clinical Trial Site 100709
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 203712
🇨🇿Varnsdorf, Czechia
Chiesi Clinical Trial Site 348706
🇭🇺Szarvas, Hungary
Chiesi Clinical Trial Site 276709
🇩🇪Berlin, Germany
Chiesi Clinical Trial Site 276705
🇩🇪Hamburg, Germany
Chiesi Clinical Trial Site 203707
🇨🇿Jindřichův Hradec, Czechia
Chiesi Clinical Trial Site 203703
🇨🇿Praha, Czechia
Chiesi Clinical Trial Site 642714
🇷🇴Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642704
🇷🇴Iaşi, Romania
Chiesi Clinical Trial Site 703707
🇸🇰Bratislava, Slovakia
Chiesi Clinical Trial Site 616722
🇵🇱Bielsko-Biala, Poland
Chiesi Clinical Trial Site 616702
🇵🇱Bienkówka, Poland
Chiesi Clinical Trial Site 616701
🇵🇱Gdańsk, Poland
Chiesi Clinical Trial Site 616721
🇵🇱Skierniewice, Poland
Chiesi Clinical Trial Site 643758
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643744
🇷🇺Nizhny Novgorod, Russian Federation
Chiesi Clinical Trial Site 643745
🇷🇺Chelyabinsk, Russian Federation
Chiesi Clinical Trial Site 643712
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643706
🇷🇺Moscow, Russian Federation
Chiesi Clinical Trial Site 616710
🇵🇱Tarnów, Poland
Chiesi Clinical Trial Site 643733
🇷🇺Chelyabinsk, Russian Federation
Chiesi Clinical Trial Site 643723
🇷🇺Nizhny Novgorod, Russian Federation
Chiesi Clinical Trial Site 380706
🇮🇹Tradate, Italy
Chiesi Clinical Trial Site 620704
🇵🇹Aveiro, Portugal
Chiesi Clinical Trial Site 620707
🇵🇹Vila Nova De Gaia, Portugal
Chiesi Clinical Trial Site 642715
🇷🇴Alexandru cel Bun, Romania
Chiesi Clinical Trial Site 642722
🇷🇴Bacău, Romania
Chiesi Clinical Trial Site 616720
🇵🇱Proszowice, Poland
Chiesi Clinical Trial Site 643724
🇷🇺Anton, Russian Federation
Chiesi Clinical Trial Site 643722
🇷🇺Moscow, Russian Federation
Chiesi Clinical Trial Site 643718
🇷🇺Moscow, Russian Federation
Chiesi Clinical Trial Site 440702
🇱🇹Vilnius, Lithuania
Chiesi Clinical Trial Site 616723
🇵🇱Rzeszów, Poland
Chiesi Clinical Trial Site 616735
🇵🇱Rzeszów, Poland
Chiesi Clinical Trial Site 616715
🇵🇱Wrocław, Poland
Chiesi Clinical Trial Site 616726
🇵🇱Łódź, Poland
Chiesi Clinical Trial Site 643719
🇷🇺Kazan, Russian Federation
Chiesi Clinical Trial Site 440705
🇱🇹Vilnius, Lithuania
Chiesi Clinical Trial Site 642712
🇷🇴Craiova, Romania
Chiesi Clinical Trial Site 643713
🇷🇺Kazan, Russian Federation
Chiesi Clinical Trial Site 616732
🇵🇱Strzelce Opolskie, Poland
Chiesi Clinical Trial Site 616707
🇵🇱Łódź, Poland
Chiesi Clinical Trial Site 616712
🇵🇱Świdnik, Poland
Chiesi Clinical Trial Site 643727
🇷🇺Chelyabinsk, Russian Federation
Chiesi Clinical Trial Site 804709
🇺🇦Kharkiv, Ukraine
Chiesi Clinical Trial Site 643736
🇷🇺Saratov, Russian Federation
Chiesi Clinical Trial Site 643705
🇷🇺Moscow, Russian Federation
Chiesi Clinical Trial Site 826703
🇬🇧London, United Kingdom
Chiesi Clinical Trial Site 826701
🇬🇧Soham, United Kingdom
Chiesi Clinical Trial Site 724707
🇪🇸Sabadell, Spain
Chiesi Clinical Trial Site 804711
🇺🇦Ivano-Frankivs'k, Ukraine
Chiesi Clinical Trial Site 804713
🇺🇦Kiev, Ukraine
Chiesi Clinical Trial Site 804705
🇺🇦Kyiv, Ukraine
Chiesi Clinical Trial Site 724702
🇪🇸Coruña, Spain
Chiesi Clinical Trial Site 643717
🇷🇺Novosibirsk, Russian Federation
Chiesi Clinical Trial Site 643715
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643701
🇷🇺Ryazan, Russian Federation
Chiesi Clinical Trial Site 643729
🇷🇺Orenburg, Russian Federation
Chiesi Clinical Trial Site 643714
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 724706
🇪🇸Badalona, Spain
Chiesi Clinical Trial Site 703706
🇸🇰Košice, Slovakia
Chiesi Clinical Trial Site 643720
🇷🇺Yaroslavl, Russian Federation
Chiesi Clinical Trial Site 724704
🇪🇸Madrid, Spain
Chiesi Clinical Trial Site 826702
🇬🇧Llanelli, United Kingdom
Chiesi Clinical Trial Site 380704
🇮🇹Bologna, Italy
Chiesi Clinical Trial Site 380705
🇮🇹Palermo, Italy
Chiesi Clinical Trial Site 792706
🇹🇷Kocaeli, Turkey
Chiesi Clinical Trial Site 826704
🇬🇧Manchester, United Kingdom
Chiesi Clinical Trial Site 620703
🇵🇹Figueira Da Foz, Portugal
Chiesi Clinical Trial Site 642707
🇷🇴Bucuresti, Romania
Chiesi Clinical Trial Site 642710
🇷🇴Iaşi, Romania
Chiesi Clinical Trial Site 703705
🇸🇰Košice, Slovakia
Chiesi Clinical Trial Site 440701
🇱🇹Šiauliai, Lithuania
Chiesi Clinical Trial Site 620708
🇵🇹Loures, Portugal
Chiesi Clinical Trial Site 642723
🇷🇴Bucuresti, Romania
Chiesi Clinical Trial Site 642709
🇷🇴Cluj-Napoca, Romania
Chiesi Clinical Trial Site 112701
🇧🇾Minsk, Belarus
Chiesi Clinical Trial Site 642708
🇷🇴Bucuresti, Romania
Chiesi Clinical Trial Site 112704
🇧🇾Gomel, Belarus
Chiesi Clinical Trial Site 620702
🇵🇹Lisboa, Portugal
Chiesi Clinical Trial Site 642713
🇷🇴Arad, Romania
Chiesi Clinical Trial Site 112703
🇧🇾Gomel, Belarus
Chiesi Clinical Trial Site 642719
🇷🇴Bucuresti, Romania
Chiesi Clinical Trial Site 642718
🇷🇴Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642705
🇷🇴Oradea, Romania
Chiesi Clinical Trial Site 642716
🇷🇴Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642721
🇷🇴Timişoara, Romania
Chiesi Clinical Trial Site 703704
🇸🇰Bratislava, Slovakia
Chiesi Clinical Trial Site 703703
🇸🇰Spišská Nová Ves, Slovakia
Chiesi Clinical Trial Site 642726
🇷🇴Cluj-Napoca, Romania
Chiesi Clinical Trial Site 703701
🇸🇰Nove Zamky, Slovakia
Chiesi Clinical Trial Site 703709
🇸🇰Prievidza, Slovakia
Chiesi Clinical Trial Site 642711
🇷🇴Suceava, Romania
Chiesi Clinical Trial Site 643754
🇷🇺Izhevsk, Russian Federation
Chiesi Clinical Trial Site 643741
🇷🇺Kazan, Russian Federation
Chiesi Clinical Trial Site 643746
🇷🇺Kazan, Russian Federation
Chiesi Clinical Trial Site 643702
🇷🇺Moscow, Russian Federation
Chiesi Clinical Trial Site 643735
🇷🇺Moscow, Russian Federation
Chiesi Clinical Trial Site 643707
🇷🇺Nizhny Novgorod, Russian Federation
Chiesi Clinical Trial Site 643711
🇷🇺Pyatigorsk, Russian Federation
Chiesi Clinical Trial Site 643704
🇷🇺Kemerovo, Russian Federation
Chiesi Clinical Trial Site 643725
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643739
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643752
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643740
🇷🇺Stavropol', Russian Federation
Chiesi Clinical Trial Site 643709
🇷🇺Tomsk, Russian Federation
Chiesi Clinical Trial Site 643726
🇷🇺Smolensk, Russian Federation
Chiesi Clinical Trial Site 643728
🇷🇺Tomsk, Russian Federation
Chiesi Clinical Trial Site 643759
🇷🇺Tomsk, Russian Federation
Chiesi Clinical Trial Site 643755
🇷🇺Ufa, Russian Federation
Chiesi Clinical Trial Site 643708
🇷🇺Vladikavkaz, Russian Federation
Chiesi Clinical Trial Site 643738
🇷🇺Vladimir, Russian Federation
Chiesi Clinical Trial Site 643734
🇷🇺Yaroslavl, Russian Federation
Chiesi Clinical Trial Site 643742
🇷🇺Yaroslavl, Russian Federation
Chiesi Clinical Trial Site 100715
🇧🇬Plovdiv, Bulgaria
Chiesi Clinical Trial Site 276703
🇩🇪Hannover, Germany
Chiesi Clinical Trial Site 276708
🇩🇪Koblenz, Germany
Chiesi Clinical Trial Site 276704
🇩🇪Leipzig, Germany
Chiesi Clinical Trial Site 276713
🇩🇪Münster, Germany
Chiesi Clinical Trial Site 643743
🇷🇺Moscow, Russian Federation
Chiesi Clinical Trial Site 203713
🇨🇿Rokycany, Czechia
Chiesi Clinical Trial Site 203706
🇨🇿Teplice, Czechia
Chiesi Clinical Trial Site 348712
🇭🇺Gödöllő, Hungary
Chiesi Clinical Trial Site 643749
🇷🇺Yaroslavl, Russian Federation
Chiesi Clinical Trial Site 276702
🇩🇪Leipzig, Germany
Chiesi Clinical Trial Site 203704
🇨🇿Opava, Czechia
Chiesi Clinical Trial Site 643721
🇷🇺Yekaterinburg, Russian Federation
Chiesi Clinical Trial Site 276710
🇩🇪Leipzig, Germany
Chiesi Clinical Trial Site 276701
🇩🇪München, Germany
Chiesi Clinical Trial Site 276716
🇩🇪Rosenheim, Germany
Chiesi Clinical Trial Site 100713
🇧🇬Haskovo, Bulgaria
Chiesi Clinical Trial Site 112705
🇧🇾Minsk, Belarus
Chiesi Clinical Trial Site 100707
🇧🇬Blagoevgrad, Bulgaria
Chiesi Clinical Trial Site 100720
🇧🇬Burgas, Bulgaria
Chiesi Clinical Trial Site 100722
🇧🇬Montana, Bulgaria
Chiesi Clinical Trial Site 100701
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 100716
🇧🇬Ruse, Bulgaria
Chiesi Clinical Trial Site 100708
🇧🇬Plovdiv, Bulgaria
Chiesi Clinical Trial Site 100702
🇧🇬Pleven, Bulgaria
Chiesi Clinical Trial Site 100711
🇧🇬Vidin, Bulgaria
Chiesi Clinical Trial Site 100719
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 100712
🇧🇬Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 100710
🇧🇬Varna, Bulgaria
Chiesi Clinical Trial Site 100706
🇧🇬Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 100721
🇧🇬Vidin, Bulgaria
Chiesi Clinical Trial Site 203711
🇨🇿Blansko, Czechia
Chiesi Clinical Trial Site 203702
🇨🇿Brandýs Nad Labem, Czechia
Chiesi Clinical Trial Site 203708
🇨🇿Brno, Czechia
Chiesi Clinical Trial Site 203709
🇨🇿Moravský Krumlov, Czechia
Chiesi Clinical Trial Site 276712
🇩🇪Berlin, Germany
Chiesi Clinical Trial Site 276711
🇩🇪Bonn, Germany
Chiesi Clinical Trial Site 276715
🇩🇪Mainz, Germany
Chiesi Clinical Trial Site 348721
🇭🇺Debrecen, Hungary
Chiesi Clinical Trial Site 348718
🇭🇺Hatvan, Hungary
Chiesi Clinical Trial Site 348715
🇭🇺Budapest, Hungary
Chiesi Clinical Trial Site 348717
🇭🇺Komárom, Hungary
Chiesi Clinical Trial Site 348709
🇭🇺Létavértes, Hungary
Chiesi Clinical Trial Site 348713
🇭🇺Pécs, Hungary
Chiesi Clinical Trial Site 348704
🇭🇺Nyíregyháza, Hungary
Chiesi Clinical Trial Site 348719
🇭🇺Mórahalom, Hungary
Chiesi Clinical Trial Site 348705
🇭🇺Szentgotthárd, Hungary
Chiesi Clinical Trial Site 348714
🇭🇺Nyíregyháza, Hungary
Chiesi Clinical Trial Site 348701
🇭🇺Szeged, Hungary
Chiesi Clinical Trial Site 348720
🇭🇺Vecsés, Hungary
Chiesi Clinical Trial Site 348708
🇭🇺Érd, Hungary
Chiesi Clinical Trial Site 380703
🇮🇹Catania, Italy
Chiesi Clinical Trial Site 348710
🇭🇺Vásárosnamény, Hungary
Chiesi Clinical Trial Site 616731
🇵🇱Otwock, Poland
Chiesi Clinical Trial Site 380702
🇮🇹Pavia, Italy
Chiesi Clinical Trial Site 440703
🇱🇹Vilnius, Lithuania
Chiesi Clinical Trial Site 616718
🇵🇱Białystok, Poland
Chiesi Clinical Trial Site 616716
🇵🇱Grudziądz, Poland
Chiesi Clinical Trial Site 616729
🇵🇱Katowice, Poland
Chiesi Clinical Trial Site 616734
🇵🇱Kraków, Poland
Chiesi Clinical Trial Site 616703
🇵🇱Pabianice, Poland
Chiesi Clinical Trial Site 616719
🇵🇱Kraków, Poland
Chiesi Clinical Trial Site 616705
🇵🇱Wrocław, Poland
Chiesi Clinical Trial Site 616717
🇵🇱Ostróda, Poland
Chiesi Clinical Trial Site 616730
🇵🇱Wilkowice, Poland
Chiesi Clinical Trial Site 642706
🇷🇴Braşov, Romania
Chiesi Clinical Trial Site 642717
🇷🇴Bragadiru, Romania
Chiesi Clinical Trial Site 642703
🇷🇴Bucuresti, Romania
Chiesi Clinical Trial Site 643731
🇷🇺Kemerovo, Russian Federation
Chiesi Clinical Trial Site 643757
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643730
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643716
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643737
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643732
🇷🇺Saint Petersburg, Russian Federation
Chiesi Clinical Trial Site 643703
🇷🇺Saratov, Russian Federation
Chiesi Clinical Trial Site 643710
🇷🇺Voronezh, Russian Federation
Chiesi Clinical Trial Site 703708
🇸🇰Štúrovo, Slovakia
Chiesi Clinical Trial Site 703702
🇸🇰Ilava, Slovakia
Chiesi Clinical Trial Site 724701
🇪🇸Madrid, Spain
Chiesi Clinical Trial Site 724705
🇪🇸Málaga, Spain
Chiesi Clinical Trial Site 792702
🇹🇷Ankara, Turkey
Chiesi Clinical Trial Site 792701
🇹🇷Ankara, Turkey
Chiesi Clinical Trial Site 792703
🇹🇷Antalya, Turkey
Chiesi Clinical Trial Site 792710
🇹🇷Aydın, Turkey
Chiesi Clinical Trial Site 792705
🇹🇷Maltepe, Turkey
Chiesi Clinical Trial Site 792707
🇹🇷Istanbul, Turkey
Chiesi Clinical Trial Site 792708
🇹🇷Mersin, Turkey
Chiesi Clinical Trial Site 804701
🇺🇦Dnipropetrovs'k, Ukraine
Chiesi Clinical Trial Site 792709
🇹🇷Yenişehir, Turkey
Chiesi Clinical Trial Site 804704
🇺🇦Zaporizhzhya, Ukraine
Chiesi Clinical Trial Site 804714
🇺🇦Vinnytsya, Ukraine
Chiesi Clinical Trial Site 616733
🇵🇱Mrozy, Poland
Chiesi Clinical Trial Site 616709
🇵🇱Poznań, Poland
Chiesi Clinical Trial Site 804710
🇺🇦Kherson, Ukraine
Chiesi Clinical Trial Site 804708
🇺🇦Zhytomyr, Ukraine
Chiesi Clinical Trial Site 616727
🇵🇱Bydgoszcz, Poland
Chiesi Clinical Trial Site 616736
🇵🇱Kraków, Poland
Chiesi Clinical Trial Site 804712
🇺🇦Lviv, Ukraine
Chiesi Clinical Trial Site 616728
🇵🇱Poznań, Poland
Chiesi Clinical Trial Site 616711
🇵🇱Łódź, Poland
Chiesi Clinical Trial Site 804715
🇺🇦Sumy, Ukraine
Chiesi Clinical Trial Site 804703
🇺🇦Vinnytsya, Ukraine
Chiesi Clinical Trial Site 804707
🇺🇦Vinnytsya, Ukraine
Chiesi Clinical Trial Site 616713
🇵🇱Białystok, Poland
Chiesi Clinical Trial Site 616725
🇵🇱Katowice, Poland
Chiesi Clinical Trial Site 616714
🇵🇱Wrocław, Poland
Chiesi Clinical Trial Site 616704
🇵🇱Giżycko, Poland
Chiesi Clinical Trial Site 616708
🇵🇱Łódź, Poland
Chiesi Clinical Trial Site 804706
🇺🇦Vinnytsya, Ukraine