Clinical trial NCT02676089: TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Official title: A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 200/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 200/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) ALONE OR ON TOP OF OPEN-LABEL TIOTROPIUM 2.5 µg RESPIMAT® IN PATIENTS WITH ASTHMA UNCONTROLLED ON HIGH DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG-ACTING ß2-AGONISTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma, Anticholinergics, Triple combination
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2016-02-08
Enrollment: 1433
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pre-dose FEV1 (Forced Expiratory Volume in the first second)
timeFrame: Week 26
measure: Reduction of moderate and severe asthma exacerbations rate
timeFrame: Week 0 to Week 52
Secondary outcomes:
measure: Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose
timeFrame: Week 26
measure: Change from baseline in morning PEF (Peak Expiratory Flow)
timeFrame: Week 0 to Week 26
measure: Reduction of severe asthma exacerbations rate
timeFrame: Week 0 to week 52
Other outcomes:
measure: Adverse Events and Adverse Drug reactions
timeFrame: Up to Week 52
measure: Collection of Health Economics outcomes
timeFrame: Week 0 to Week 52
Locations:
city: Caba
country: Argentina
facility: Chiesi Clinical Trial Site 432704
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Chiesi Clinical Trial Site 432702
city: Mar Del Plata
country: Argentina
facility: Chiesi Clinical Trial Site 432705
city: Quilmes
country: Argentina
facility: Chiesi Clinical Trial Site 432701
city: San Miguel de Tucumán
country: Argentina
facility: Chiesi Clinical Trial Site 432703
city: Tucuman
country: Argentina
facility: Chiesi Clinical Trial Site 432706
city: Gomel
country: Belarus
facility: Chiesi Clinical Trial Site 112703
city: Gomel
country: Belarus
facility: Chiesi Clinical Trial Site 112704
city: Minsk
country: Belarus
facility: Chiesi Clinical Trial Site 112701
city: Minsk
country: Belarus
facility: Chiesi Clinical Trial Site 112702
city: Minsk
country: Belarus
facility: Chiesi Clinical Trial Site 112705
city: Blagoevgrad
country: Bulgaria
facility: Chiesi Clinical Trial Site 100707
city: Burgas
country: Bulgaria
facility: Chiesi Clinical Trial Site 100720
city: Gabrovo
country: Bulgaria
facility: Chiesi Clinical Trial Site 100718
city: Haskovo
country: Bulgaria
facility: Chiesi Clinical Trial Site 100713
city: Montana
country: Bulgaria
facility: Chiesi Clinical Trial Site 100722
city: Pleven
country: Bulgaria
facility: Chiesi Clinical Trial Site 100702
city: Plovdiv
country: Bulgaria
facility: Chiesi Clinical Trial Site 100705
city: Plovdiv
country: Bulgaria
facility: Chiesi Clinical Trial Site 100708
city: Plovdiv
country: Bulgaria
facility: Chiesi Clinical Trial Site 100715
city: Ruse
country: Bulgaria
facility: Chiesi Clinical Trial Site 100716
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 100701
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 100703
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 100704
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 100709
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 100719
city: Stara Zagora
country: Bulgaria
facility: Chiesi Clinical Trial Site 100706
city: Stara Zagora
country: Bulgaria
facility: Chiesi Clinical Trial Site 100712
city: Varna
country: Bulgaria
facility: Chiesi Clinical Trial Site 100710
city: Vidin
country: Bulgaria
facility: Chiesi Clinical Trial Site 100711
city: Vidin
country: Bulgaria
facility: Chiesi Clinical Trial Site 100721
city: Blansko
country: Czechia
facility: Chiesi Clinical Trial Site 203711
city: Brandýs Nad Labem
country: Czechia
facility: Chiesi Clinical Trial Site 203702
city: Brno
country: Czechia
facility: Chiesi Clinical Trial Site 203708
city: Jindřichův Hradec
country: Czechia
facility: Chiesi Clinical Trial Site 203707
city: Kralupy Nad Vltavou
country: Czechia
facility: Chiesi Clinical Trial Site 203705
city: Moravský Krumlov
country: Czechia
facility: Chiesi Clinical Trial Site 203709
city: Opava
country: Czechia
facility: Chiesi Clinical Trial Site 203704
city: Praha
country: Czechia
facility: Chiesi Clinical Trial Site 203701
city: Praha
country: Czechia
facility: Chiesi Clinical Trial Site 203703
city: Praha
country: Czechia
facility: Chiesi Clinical Trial Site 203710
city: Rokycany
country: Czechia
facility: Chiesi Clinical Trial Site 203713
city: Teplice
country: Czechia
facility: Chiesi Clinical Trial Site 203706
city: Varnsdorf
country: Czechia
facility: Chiesi Clinical Trial Site 203712
city: Berlin
country: Germany
facility: Chiesi Clinical Trial Site 276709
city: Berlin
country: Germany
facility: Chiesi Clinical Trial Site 276712
city: Bonn
country: Germany
facility: Chiesi Clinical Trial Site 276711
city: Frankfurt am Main
country: Germany
facility: Chiesi Clinical Trial Site 276707
city: Frankfurt am Main
country: Germany
facility: Chiesi Clinical Trial Site 276714
city: Hamburg
country: Germany
facility: Chiesi Clinical Trial Site 276705
city: Hannover
country: Germany
facility: Chiesi Clinical Trial Site 276703
city: Koblenz
country: Germany
facility: Chiesi Clinical Trial Site 276708
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site 276702
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site 276704
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site 276710
city: Mainz
country: Germany
facility: Chiesi Clinical Trial Site 276715
city: München
country: Germany
facility: Chiesi Clinical Trial Site 276701
city: Münster
country: Germany
facility: Chiesi Clinical Trial Site 276713
city: Rosenheim
country: Germany
facility: Chiesi Clinical Trial Site 276716
city: Balassagyarmat
country: Hungary
facility: Chiesi Clinical Trial Site 348707
city: Budapest
country: Hungary
facility: Chiesi Clinical Trial Site 348715
city: Debrecen
country: Hungary
facility: Chiesi Clinical Trial Site 348721
city: Gödöllő
country: Hungary
facility: Chiesi Clinical Trial Site 348712
city: Hatvan
country: Hungary
facility: Chiesi Clinical Trial Site 348718
city: Komárom
country: Hungary
facility: Chiesi Clinical Trial Site 348717
city: Létavértes
country: Hungary
facility: Chiesi Clinical Trial Site 348709
city: Monor
country: Hungary
facility: Chiesi Clinical Trial Site 348703
city: Mórahalom
country: Hungary
facility: Chiesi Clinical Trial Site 348719
city: Nyíregyháza
country: Hungary
facility: Chiesi Clinical Trial Site 348704
city: Nyíregyháza
country: Hungary
facility: Chiesi Clinical Trial Site 348714
city: Pécs
country: Hungary
facility: Chiesi Clinical Trial Site 348713
city: Siófok
country: Hungary
facility: Chiesi Clinical Trial Site 348702
city: Szarvas
country: Hungary
facility: Chiesi Clinical Trial Site 348706
city: Szeged
country: Hungary
facility: Chiesi Clinical Trial Site 348701
city: Szentgotthárd
country: Hungary
facility: Chiesi Clinical Trial Site 348705
city: Vecsés
country: Hungary
facility: Chiesi Clinical Trial Site 348720
city: Vásárosnamény
country: Hungary
facility: Chiesi Clinical Trial Site 348710
city: Érd
country: Hungary
facility: Chiesi Clinical Trial Site 348708
city: Bologna
country: Italy
facility: Chiesi Clinical Trial Site 380704
city: Catania
country: Italy
facility: Chiesi Clinical Trial Site 380703
city: Genova
country: Italy
facility: Chiesi Clinical Trial Site 380701
city: Palermo
country: Italy
facility: Chiesi Clinical Trial Site 380705
city: Pavia
country: Italy
facility: Chiesi Clinical Trial Site 380702
city: Tradate
country: Italy
facility: Chiesi Clinical Trial Site 380706
city: Vilnius
country: Lithuania
facility: Chiesi Clinical Trial Site 440702
city: Vilnius
country: Lithuania
facility: Chiesi Clinical Trial Site 440703
city: Vilnius
country: Lithuania
facility: Chiesi Clinical Trial Site 440705
city: Šiauliai
country: Lithuania
facility: Chiesi Clinical Trial Site 440701
city: Białystok
country: Poland
facility: Chiesi Clinical Trial Site 616713
city: Białystok
country: Poland
facility: Chiesi Clinical Trial Site 616718
city: Bielsko-Biala
country: Poland
facility: Chiesi Clinical Trial Site 616722
city: Bienkówka
country: Poland
facility: Chiesi Clinical Trial Site 616702
city: Bydgoszcz
country: Poland
facility: Chiesi Clinical Trial Site 616727
city: Gdańsk
country: Poland
facility: Chiesi Clinical Trial Site 616701
city: Giżycko
country: Poland
facility: Chiesi Clinical Trial Site 616704
city: Grudziądz
country: Poland
facility: Chiesi Clinical Trial Site 616716
city: Katowice
country: Poland
facility: Chiesi Clinical Trial Site 616725
city: Katowice
country: Poland
facility: Chiesi Clinical Trial Site 616729
city: Kraków
country: Poland
facility: Chiesi Clinical Trial Site 616719
city: Kraków
country: Poland
facility: Chiesi Clinical Trial Site 616734
city: Kraków
country: Poland
facility: Chiesi Clinical Trial Site 616736
city: Mrozy
country: Poland
facility: Chiesi Clinical Trial Site 616733
city: Ostróda
country: Poland
facility: Chiesi Clinical Trial Site 616717
city: Otwock
country: Poland
facility: Chiesi Clinical Trial Site 616731
city: Pabianice
country: Poland
facility: Chiesi Clinical Trial Site 616703
city: Poznań
country: Poland
facility: Chiesi Clinical Trial Site 616709
city: Poznań
country: Poland
facility: Chiesi Clinical Trial Site 616728
city: Proszowice
country: Poland
facility: Chiesi Clinical Trial Site 616720
city: Rzeszów
country: Poland
facility: Chiesi Clinical Trial Site 616723
city: Rzeszów
country: Poland
facility: Chiesi Clinical Trial Site 616735
city: Skierniewice
country: Poland
facility: Chiesi Clinical Trial Site 616721
city: Strzelce Opolskie
country: Poland
facility: Chiesi Clinical Trial Site 616732
city: Tarnów
country: Poland
facility: Chiesi Clinical Trial Site 616710
city: Wilkowice
country: Poland
facility: Chiesi Clinical Trial Site 616730
city: Wrocław
country: Poland
facility: Chiesi Clinical Trial Site 616705
city: Wrocław
country: Poland
facility: Chiesi Clinical Trial Site 616714
city: Wrocław
country: Poland
facility: Chiesi Clinical Trial Site 616715
city: Łódź
country: Poland
facility: Chiesi Clinical Trial Site 616707
city: Łódź
country: Poland
facility: Chiesi Clinical Trial Site 616708
city: Łódź
country: Poland
facility: Chiesi Clinical Trial Site 616711
city: Łódź
country: Poland
facility: Chiesi Clinical Trial Site 616726
city: Świdnik
country: Poland
facility: Chiesi Clinical Trial Site 616712
city: Aveiro
country: Portugal
facility: Chiesi Clinical Trial Site 620704
city: Figueira Da Foz
country: Portugal
facility: Chiesi Clinical Trial Site 620703
city: Lisboa
country: Portugal
facility: Chiesi Clinical Trial Site 620702
city: Loures
country: Portugal
facility: Chiesi Clinical Trial Site 620708
city: Vila Nova De Gaia
country: Portugal
facility: Chiesi Clinical Trial Site 620707
city: Alexandru cel Bun
country: Romania
facility: Chiesi Clinical Trial Site 642715
city: Arad
country: Romania
facility: Chiesi Clinical Trial Site 642713
city: Bacău
country: Romania
facility: Chiesi Clinical Trial Site 642722
city: Bragadiru
country: Romania
facility: Chiesi Clinical Trial Site 642717
city: Braşov
country: Romania
facility: Chiesi Clinical Trial Site 642706
city: Bucuresti
country: Romania
facility: Chiesi Clinical Trial Site 642703
city: Bucuresti
country: Romania
facility: Chiesi Clinical Trial Site 642707
city: Bucuresti
country: Romania
facility: Chiesi Clinical Trial Site 642708
city: Bucuresti
country: Romania
facility: Chiesi Clinical Trial Site 642719
city: Bucuresti
country: Romania
facility: Chiesi Clinical Trial Site 642723
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial Site 642709
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial Site 642714
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial Site 642716
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial Site 642718
city: Cluj-Napoca
country: Romania
facility: Chiesi Clinical Trial Site 642726
city: Craiova
country: Romania
facility: Chiesi Clinical Trial Site 642712
city: Iaşi
country: Romania
facility: Chiesi Clinical Trial Site 642704
city: Iaşi
country: Romania
facility: Chiesi Clinical Trial Site 642710
city: Oradea
country: Romania
facility: Chiesi Clinical Trial Site 642705
city: Suceava
country: Romania
facility: Chiesi Clinical Trial Site 642711
city: Timişoara
country: Romania
facility: Chiesi Clinical Trial Site 642721
city: Anton
country: Russian Federation
facility: Chiesi Clinical Trial Site 643724
city: Chelyabinsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643727
city: Chelyabinsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643733
city: Chelyabinsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643745
city: Izhevsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643754
city: Kazan
country: Russian Federation
facility: Chiesi Clinical Trial Site 643713
city: Kazan
country: Russian Federation
facility: Chiesi Clinical Trial Site 643719
city: Kazan
country: Russian Federation
facility: Chiesi Clinical Trial Site 643741
city: Kazan
country: Russian Federation
facility: Chiesi Clinical Trial Site 643746
city: Kemerovo
country: Russian Federation
facility: Chiesi Clinical Trial Site 643704
city: Kemerovo
country: Russian Federation
facility: Chiesi Clinical Trial Site 643731
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial Site 643702
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial Site 643705
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial Site 643706
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial Site 643718
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial Site 643722
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial Site 643735
city: Moscow
country: Russian Federation
facility: Chiesi Clinical Trial Site 643743
city: Nizhny Novgorod
country: Russian Federation
facility: Chiesi Clinical Trial Site 643707
city: Nizhny Novgorod
country: Russian Federation
facility: Chiesi Clinical Trial Site 643723
city: Nizhny Novgorod
country: Russian Federation
facility: Chiesi Clinical Trial Site 643744
city: Novosibirsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643717
city: Orenburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643729
city: Pyatigorsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643711
city: Ryazan
country: Russian Federation
facility: Chiesi Clinical Trial Site 643701
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643712
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643714
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643715
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643716
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643725
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643730
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643732
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643737
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643739
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643752
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643757
city: Saint Petersburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643758
city: Saratov
country: Russian Federation
facility: Chiesi Clinical Trial Site 643703
city: Saratov
country: Russian Federation
facility: Chiesi Clinical Trial Site 643736
city: Smolensk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643726
city: Stavropol'
country: Russian Federation
facility: Chiesi Clinical Trial Site 643740
city: Tomsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643709
city: Tomsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643728
city: Tomsk
country: Russian Federation
facility: Chiesi Clinical Trial Site 643759
city: Ufa
country: Russian Federation
facility: Chiesi Clinical Trial Site 643755
city: Vladikavkaz
country: Russian Federation
facility: Chiesi Clinical Trial Site 643708
city: Vladimir
country: Russian Federation
facility: Chiesi Clinical Trial Site 643738
city: Voronezh
country: Russian Federation
facility: Chiesi Clinical Trial Site 643710
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial Site 643720
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial Site 643734
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial Site 643742
city: Yaroslavl
country: Russian Federation
facility: Chiesi Clinical Trial Site 643749
city: Yekaterinburg
country: Russian Federation
facility: Chiesi Clinical Trial Site 643721
city: Bratislava
country: Slovakia
facility: Chiesi Clinical Trial Site 703704
city: Bratislava
country: Slovakia
facility: Chiesi Clinical Trial Site 703707
city: Ilava
country: Slovakia
facility: Chiesi Clinical Trial Site 703702
city: Košice
country: Slovakia
facility: Chiesi Clinical Trial Site 703705
city: Košice
country: Slovakia
facility: Chiesi Clinical Trial Site 703706
city: Nove Zamky
country: Slovakia
facility: Chiesi Clinical Trial Site 703701
city: Prievidza
country: Slovakia
facility: Chiesi Clinical Trial Site 703709
city: Spišská Nová Ves
country: Slovakia
facility: Chiesi Clinical Trial Site 703703
city: Štúrovo
country: Slovakia
facility: Chiesi Clinical Trial Site 703708
city: Badajoz
country: Spain
facility: Chiesi Clinical Trial Site 724703
city: Badalona
country: Spain
facility: Chiesi Clinical Trial Site 724706
city: Coruña
country: Spain
facility: Chiesi Clinical Trial Site 724702
city: Madrid
country: Spain
facility: Chiesi Clinical Trial Site 724701
city: Madrid
country: Spain
facility: Chiesi Clinical Trial Site 724704
city: Málaga
country: Spain
facility: Chiesi Clinical Trial Site 724705
city: Sabadell
country: Spain
facility: Chiesi Clinical Trial Site 724707
city: Ankara
country: Turkey
facility: Chiesi Clinical Trial Site 792701
city: Ankara
country: Turkey
facility: Chiesi Clinical Trial Site 792702
city: Antalya
country: Turkey
facility: Chiesi Clinical Trial Site 792703
city: Aydın
country: Turkey
facility: Chiesi Clinical Trial Site 792710
city: Istanbul
country: Turkey
facility: Chiesi Clinical Trial Site 792707
city: Kocaeli
country: Turkey
facility: Chiesi Clinical Trial Site 792706
city: Maltepe
country: Turkey
facility: Chiesi Clinical Trial Site 792705
city: Mersin
country: Turkey
facility: Chiesi Clinical Trial Site 792708
city: Yenişehir
country: Turkey
facility: Chiesi Clinical Trial Site 792709
city: Dnipropetrovs'k
country: Ukraine
facility: Chiesi Clinical Trial Site 804701
city: Ivano-Frankivs'k
country: Ukraine
facility: Chiesi Clinical Trial Site 804711
city: Kharkiv
country: Ukraine
facility: Chiesi Clinical Trial Site 804709
city: Kherson
country: Ukraine
facility: Chiesi Clinical Trial Site 804710
city: Kiev
country: Ukraine
facility: Chiesi Clinical Trial Site 804713
city: Kyiv
country: Ukraine
facility: Chiesi Clinical Trial Site 804705
city: Lviv
country: Ukraine
facility: Chiesi Clinical Trial Site 804712
city: Sumy
country: Ukraine
facility: Chiesi Clinical Trial Site 804715
city: Vinnytsya
country: Ukraine
facility: Chiesi Clinical Trial Site 804703
city: Vinnytsya
country: Ukraine
facility: Chiesi Clinical Trial Site 804706
city: Vinnytsya
country: Ukraine
facility: Chiesi Clinical Trial Site 804707
city: Vinnytsya
country: Ukraine
facility: Chiesi Clinical Trial Site 804714
city: Zaporizhzhya
country: Ukraine
facility: Chiesi Clinical Trial Site 804704
city: Zhytomyr
country: Ukraine
facility: Chiesi Clinical Trial Site 804708
city: Llanelli
country: United Kingdom
facility: Chiesi Clinical Trial Site 826702
city: London
country: United Kingdom
facility: Chiesi Clinical Trial Site 826703
city: Manchester
country: United Kingdom
facility: Chiesi Clinical Trial Site 826704
city: Soham
country: United Kingdom
facility: Chiesi Clinical Trial Site 826701
Study officials:
affiliation: University of Medicine, Genoa, Italy
name: Georgio Walter Canonica, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.