TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
TRIGGER
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
2 other identifiers
interventional
1,433
17 countries
244
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Apr 2016
Typical duration for phase_3 asthma
244 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2016
CompletedFirst Posted
Study publicly available on registry
February 8, 2016
CompletedStudy Start
First participant enrolled
April 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2018
CompletedApril 8, 2021
April 1, 2021
2.1 years
February 3, 2016
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pre-dose FEV1 (Forced Expiratory Volume in the first second)
Week 26
Reduction of moderate and severe asthma exacerbations rate
Week 0 to Week 52
Secondary Outcomes (3)
Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose
Week 26
Change from baseline in morning PEF (Peak Expiratory Flow)
Week 0 to Week 26
Reduction of severe asthma exacerbations rate
Week 0 to week 52
Other Outcomes (2)
Adverse Events and Adverse Drug reactions
Up to Week 52
Collection of Health Economics outcomes
Week 0 to Week 52
Study Arms (3)
CHF 5993 200/6/12.5 µg
EXPERIMENTALTreatment 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
ACTIVE COMPARATORTreatment B: CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF
CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
ACTIVE COMPARATORTreatment 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (244)
Chiesi Clinical Trial Site 432702
Buenos Aires, Argentina
Chiesi Clinical Trial Site 432704
CABA, Argentina
Chiesi Clinical Trial Site 432705
Mar del Plata, Argentina
Chiesi Clinical Trial Site 432701
Quilmes, Argentina
Chiesi Clinical Trial Site 432703
San Miguel de Tucumán, Argentina
Chiesi Clinical Trial Site 432706
San Miguel de Tucumán, Argentina
Chiesi Clinical Trial Site 112703
Homyel, Belarus
Chiesi Clinical Trial Site 112704
Homyel, Belarus
Chiesi Clinical Trial Site 112701
Minsk, Belarus
Chiesi Clinical Trial Site 112702
Minsk, Belarus
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 100718
Gabrovo, Bulgaria
Chiesi Clinical Trial Site 100713
Haskovo, Bulgaria
Chiesi Clinical Trial Site 100722
Montana, Bulgaria
Chiesi Clinical Trial Site 100702
Pleven, Bulgaria
Chiesi Clinical Trial Site 100705
Plovdiv, Bulgaria
Chiesi Clinical Trial Site 100708
Plovdiv, Bulgaria
Chiesi Clinical Trial Site 100715
Plovdiv, Bulgaria
Chiesi Clinical Trial Site 100716
Rousse, Bulgaria
Chiesi Clinical Trial Site 100701
Sofia, Bulgaria
Chiesi Clinical Trial Site 100703
Sofia, Bulgaria
Chiesi Clinical Trial Site 100704
Sofia, Bulgaria
Chiesi Clinical Trial Site 100709
Sofia, Bulgaria
Chiesi Clinical Trial Site 100719
Sofia, Bulgaria
Chiesi Clinical Trial Site 100706
Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 100712
Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 100710
Varna, Bulgaria
Chiesi Clinical Trial Site 100711
Vidin, 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 203707
Jindřichův Hradec, Czechia
Chiesi Clinical Trial Site 203705
Kralupy nad Vltavou, Czechia
Chiesi Clinical Trial Site 203709
Moravský Krumlov, Czechia
Chiesi Clinical Trial Site 203704
Opava, Czechia
Chiesi Clinical Trial Site 203701
Prague, Czechia
Chiesi Clinical Trial Site 203703
Prague, Czechia
Chiesi Clinical Trial Site 203710
Prague, Czechia
Chiesi Clinical Trial Site 203713
Rokycany, Czechia
Chiesi Clinical Trial Site 203706
Teplice, Czechia
Chiesi Clinical Trial Site 203712
Varnsdorf, Czechia
Chiesi Clinical Trial Site 276709
Berlin, Germany
Chiesi Clinical Trial Site 276712
Berlin, Germany
Chiesi Clinical Trial Site 276711
Bonn, Germany
Chiesi Clinical Trial Site 276707
Frankfurt am Main, Germany
Chiesi Clinical Trial Site 276714
Frankfurt am Main, Germany
Chiesi Clinical Trial Site 276705
Hamburg, Germany
Chiesi Clinical Trial Site 276703
Hanover, Germany
Chiesi Clinical Trial Site 276708
Koblenz, Germany
Chiesi Clinical Trial Site 276702
Leipzig, Germany
Chiesi Clinical Trial Site 276704
Leipzig, Germany
Chiesi Clinical Trial Site 276710
Leipzig, Germany
Chiesi Clinical Trial Site 276715
Mainz, Germany
Chiesi Clinical Trial Site 276701
München, Germany
Chiesi Clinical Trial Site 276713
Münster, Germany
Chiesi Clinical Trial Site 276716
Rosenheim, Germany
Chiesi Clinical Trial Site 348707
Balassagyarmat, Hungary
Chiesi Clinical Trial Site 348715
Budapest, Hungary
Chiesi Clinical Trial Site 348721
Debrecen, Hungary
Chiesi Clinical Trial Site 348708
Érd, Hungary
Chiesi Clinical Trial Site 348712
Gödöllő, Hungary
Chiesi Clinical Trial Site 348718
Hatvan, Hungary
Chiesi Clinical Trial Site 348717
Komárom, Hungary
Chiesi Clinical Trial Site 348709
Létavértes, Hungary
Chiesi Clinical Trial Site 348703
Monor, Hungary
Chiesi Clinical Trial Site 348719
Mórahalom, Hungary
Chiesi Clinical Trial Site 348704
Nyíregyháza, Hungary
Chiesi Clinical Trial Site 348714
Nyíregyháza, Hungary
Chiesi Clinical Trial Site 348713
Pécs, Hungary
Chiesi Clinical Trial Site 348702
Siófok, Hungary
Chiesi Clinical Trial Site 348706
Szarvas, Hungary
Chiesi Clinical Trial Site 348701
Szeged, Hungary
Chiesi Clinical Trial Site 348705
Szentgotthárd, Hungary
Chiesi Clinical Trial Site 348710
Vásárosnamény, Hungary
Chiesi Clinical Trial Site 348720
Vecsés, Hungary
Chiesi Clinical Trial Site 380704
Bologna, Italy
Chiesi Clinical Trial Site 380703
Catania, Italy
Chiesi Clinical Trial Site 380701
Genova, Italy
Chiesi Clinical Trial Site 380705
Palermo, Italy
Chiesi Clinical Trial Site 380702
Pavia, Italy
Chiesi Clinical Trial Site 380706
Tradate, Italy
Chiesi Clinical Trial Site 440701
Šiauliai, Lithuania
Chiesi Clinical Trial Site 440702
Vilnius, Lithuania
Chiesi Clinical Trial Site 440703
Vilnius, Lithuania
Chiesi Clinical Trial Site 440705
Vilnius, Lithuania
Chiesi Clinical Trial Site 616713
Bialystok, Poland
Chiesi Clinical Trial Site 616718
Bialystok, Poland
Chiesi Clinical Trial Site 616722
Bielsko-Biala, Poland
Chiesi Clinical Trial Site 616702
Bienkówka, Poland
Chiesi Clinical Trial Site 616727
Bydgoszcz, Poland
Chiesi Clinical Trial Site 616701
Gdansk, Poland
Chiesi Clinical Trial Site 616704
Giżycko, Poland
Chiesi Clinical Trial Site 616716
Grudziądz, Poland
Chiesi Clinical Trial Site 616725
Katowice, Poland
Chiesi Clinical Trial Site 616729
Katowice, Poland
Chiesi Clinical Trial Site 616719
Krakow, Poland
Chiesi Clinical Trial Site 616734
Krakow, Poland
Chiesi Clinical Trial Site 616736
Krakow, Poland
Chiesi Clinical Trial Site 616707
Lodz, Poland
Chiesi Clinical Trial Site 616708
Lodz, Poland
Chiesi Clinical Trial Site 616711
Lodz, Poland
Chiesi Clinical Trial Site 616726
Lodz, Poland
Chiesi Clinical Trial Site 616733
Mrozy, Poland
Chiesi Clinical Trial Site 616717
Ostróda, Poland
Chiesi Clinical Trial Site 616731
Otwock, Poland
Chiesi Clinical Trial Site 616703
Pabianice, Poland
Chiesi Clinical Trial Site 616709
Poznan, Poland
Chiesi Clinical Trial Site 616728
Poznan, Poland
Chiesi Clinical Trial Site 616720
Proszowice, Poland
Chiesi Clinical Trial Site 616723
Rzeszów, Poland
Chiesi Clinical Trial Site 616735
Rzeszów, Poland
Chiesi Clinical Trial Site 616721
Skierniewice, Poland
Chiesi Clinical Trial Site 616732
Strzelce Opolskie, Poland
Chiesi Clinical Trial Site 616712
Świdnik, Poland
Chiesi Clinical Trial Site 616710
Tarnów, Poland
Chiesi Clinical Trial Site 616730
Wilkowice, Poland
Chiesi Clinical Trial Site 616705
Wroclaw, Poland
Chiesi Clinical Trial Site 616714
Wroclaw, Poland
Chiesi Clinical Trial Site 616715
Wroclaw, Poland
Chiesi Clinical Trial Site 620704
Aveiro, Portugal
Chiesi Clinical Trial Site 620703
Figueira da Foz Municipality, Portugal
Chiesi Clinical Trial Site 620702
Lisbon, Portugal
Chiesi Clinical Trial Site 620708
Loures, Portugal
Chiesi Clinical Trial Site 620707
Vila Nova de Gaia, Portugal
Chiesi Clinical Trial Site 642715
Alexandru cel Bun, Romania
Chiesi Clinical Trial Site 642713
Arad, Romania
Chiesi Clinical Trial Site 642722
Bacau, Romania
Chiesi Clinical Trial Site 642717
Bragadiru, Romania
Chiesi Clinical Trial Site 642706
Brasov, Romania
Chiesi Clinical Trial Site 642703
Bucharest, Romania
Chiesi Clinical Trial Site 642707
Bucharest, Romania
Chiesi Clinical Trial Site 642708
Bucharest, Romania
Chiesi Clinical Trial Site 642719
Bucharest, Romania
Chiesi Clinical Trial Site 642723
Bucharest, Romania
Chiesi Clinical Trial Site 642709
Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642714
Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642716
Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642718
Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642726
Cluj-Napoca, Romania
Chiesi Clinical Trial Site 642712
Craiova, Romania
Chiesi Clinical Trial Site 642704
Iași, Romania
Chiesi Clinical Trial Site 642710
Iași, Romania
Chiesi Clinical Trial Site 642705
Oradea, Romania
Chiesi Clinical Trial Site 642711
Suceava, Romania
Chiesi Clinical Trial Site 642721
Timișoara, Romania
Chiesi Clinical Trial Site 643724
Anton, Russia
Chiesi Clinical Trial Site 643727
Chelyabinsk, Russia
Chiesi Clinical Trial Site 643733
Chelyabinsk, Russia
Chiesi Clinical Trial Site 643745
Chelyabinsk, Russia
Chiesi Clinical Trial Site 643754
Izhevsk, Russia
Chiesi Clinical Trial Site 643713
Kazan', Russia
Chiesi Clinical Trial Site 643719
Kazan', Russia
Chiesi Clinical Trial Site 643741
Kazan', Russia
Chiesi Clinical Trial Site 643746
Kazan', Russia
Chiesi Clinical Trial Site 643704
Kemerovo, Russia
Chiesi Clinical Trial Site 643731
Kemerovo, Russia
Chiesi Clinical Trial Site 643702
Moscow, Russia
Chiesi Clinical Trial Site 643705
Moscow, Russia
Chiesi Clinical Trial Site 643706
Moscow, Russia
Chiesi Clinical Trial Site 643718
Moscow, Russia
Chiesi Clinical Trial Site 643722
Moscow, Russia
Chiesi Clinical Trial Site 643735
Moscow, Russia
Chiesi Clinical Trial Site 643743
Moscow, Russia
Chiesi Clinical Trial Site 643707
Nizhny Novgorod, Russia
Chiesi Clinical Trial Site 643723
Nizhny Novgorod, Russia
Chiesi Clinical Trial Site 643744
Nizhny Novgorod, Russia
Chiesi Clinical Trial Site 643717
Novosibirsk, Russia
Chiesi Clinical Trial Site 643729
Orenburg, Russia
Chiesi Clinical Trial Site 643711
Pyatigorsk, Russia
Chiesi Clinical Trial Site 643701
Ryazan, Russia
Chiesi Clinical Trial Site 643712
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643714
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643715
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643716
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643725
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643730
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643732
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643737
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643739
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643752
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643757
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643758
Saint Petersburg, Russia
Chiesi Clinical Trial Site 643703
Saratov, Russia
Chiesi Clinical Trial Site 643736
Saratov, Russia
Chiesi Clinical Trial Site 643726
Smolensk, Russia
Chiesi Clinical Trial Site 643740
Stavropol, Russia
Chiesi Clinical Trial Site 643709
Tomsk, Russia
Chiesi Clinical Trial Site 643728
Tomsk, Russia
Chiesi Clinical Trial Site 643759
Tomsk, Russia
Chiesi Clinical Trial Site 643755
Ufa, Russia
Chiesi Clinical Trial Site 643708
Vladikavkaz, Russia
Chiesi Clinical Trial Site 643738
Vladimir, Russia
Chiesi Clinical Trial Site 643710
Voronezh, Russia
Chiesi Clinical Trial Site 643720
Yaroslavl, Russia
Chiesi Clinical Trial Site 643734
Yaroslavl, Russia
Chiesi Clinical Trial Site 643742
Yaroslavl, Russia
Chiesi Clinical Trial Site 643749
Yaroslavl, Russia
Chiesi Clinical Trial Site 643721
Yekaterinburg, Russia
Chiesi Clinical Trial Site 703704
Bratislava, Slovakia
Chiesi Clinical Trial Site 703707
Bratislava, Slovakia
Chiesi Clinical Trial Site 703702
Ilava, Slovakia
Chiesi Clinical Trial Site 703705
Košice, Slovakia
Chiesi Clinical Trial Site 703706
Košice, Slovakia
Chiesi Clinical Trial Site 703701
Nové Zámky, Slovakia
Chiesi Clinical Trial Site 703709
Prievidza, Slovakia
Chiesi Clinical Trial Site 703703
Spišská Nová Ves, Slovakia
Chiesi Clinical Trial Site 703708
Štúrovo, Slovakia
Chiesi Clinical Trial Site 724702
A Coruña, Spain
Chiesi Clinical Trial Site 724703
Badajoz, Spain
Chiesi Clinical Trial Site 724706
Badalona, Spain
Chiesi Clinical Trial Site 724701
Madrid, Spain
Chiesi Clinical Trial Site 724704
Madrid, Spain
Chiesi Clinical Trial Site 724705
Málaga, Spain
Chiesi Clinical Trial Site 724707
Sabadell, Spain
Chiesi Clinical Trial Site 792701
Ankara, Turkey (Türkiye)
Chiesi Clinical Trial Site 792702
Ankara, Turkey (Türkiye)
Chiesi Clinical Trial Site 792703
Antalya, Turkey (Türkiye)
Chiesi Clinical Trial Site 792710
Aydin, Turkey (Türkiye)
Chiesi Clinical Trial Site 792707
Istanbul, Turkey (Türkiye)
Chiesi Clinical Trial Site 792706
Kocaeli, Turkey (Türkiye)
Chiesi Clinical Trial Site 792705
Maltepe, Turkey (Türkiye)
Chiesi Clinical Trial Site 792708
Mersin, Turkey (Türkiye)
Chiesi Clinical Trial Site 792709
Yenişehir, Turkey (Türkiye)
Chiesi Clinical Trial Site 804701
Dnipro, Ukraine
Chiesi Clinical Trial Site 804711
Ivano-Frankivsk, Ukraine
Chiesi Clinical Trial Site 804709
Kharkiv, Ukraine
Chiesi Clinical Trial Site 804710
Kherson, Ukraine
Chiesi Clinical Trial Site 804713
Kiev, Ukraine
Chiesi Clinical Trial Site 804705
Kyiv, Ukraine
Chiesi Clinical Trial Site 804712
Lviv, Ukraine
Chiesi Clinical Trial Site 804715
Sumy, Ukraine
Chiesi Clinical Trial Site 804703
Vinnytsia, Ukraine
Chiesi Clinical Trial Site 804706
Vinnytsia, Ukraine
Chiesi Clinical Trial Site 804707
Vinnytsia, Ukraine
Chiesi Clinical Trial Site 804714
Vinnytsia, Ukraine
Chiesi Clinical Trial Site 804704
Zaporizhzhya, Ukraine
Chiesi Clinical Trial Site 804708
Zhytomyr, Ukraine
Chiesi Clinical Trial Site 826702
Llanelli, United Kingdom
Chiesi Clinical Trial Site 826703
London, United Kingdom
Chiesi Clinical Trial Site 826704
Manchester, United Kingdom
Chiesi Clinical Trial Site 826701
Soham, United Kingdom
Related Publications (6)
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.
PMID: 31582314RESULTOba 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.
PMID: 36472162DERIVEDOrlovic 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.
PMID: 35872377DERIVEDPapi 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.
PMID: 35450196DERIVEDSingh 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.
PMID: 33121501DERIVEDSingh 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.
PMID: 32430414DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgio Walter Canonica, MD
University of Medicine, Genoa, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2016
First Posted
February 8, 2016
Study Start
April 6, 2016
Primary Completion
May 28, 2018
Study Completion
May 28, 2018
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.