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TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER) (TRIGGER)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CHF 5993 200/6/12.5 µg
CHF 1535 200/6 µg
CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Anticholinergics, Triple combination

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chiesi Clinical Trial Site 432704
  • Chiesi Clinical Trial Site 432702
  • Chiesi Clinical Trial Site 432705
  • Chiesi Clinical Trial Site 432701
  • Chiesi Clinical Trial Site 432703
  • Chiesi Clinical Trial Site 432706
  • Chiesi Clinical Trial Site 112703
  • Chiesi Clinical Trial Site 112704
  • Chiesi Clinical Trial Site 112701
  • Chiesi Clinical Trial Site 112702
  • Chiesi Clinical Trial Site 112705
  • Chiesi Clinical Trial Site 100707
  • Chiesi Clinical Trial Site 100720
  • Chiesi Clinical Trial Site 100718
  • Chiesi Clinical Trial Site 100713
  • Chiesi Clinical Trial Site 100722
  • Chiesi Clinical Trial Site 100702
  • Chiesi Clinical Trial Site 100705
  • Chiesi Clinical Trial Site 100708
  • Chiesi Clinical Trial Site 100715
  • Chiesi Clinical Trial Site 100716
  • Chiesi Clinical Trial Site 100701
  • Chiesi Clinical Trial Site 100703
  • Chiesi Clinical Trial Site 100704
  • Chiesi Clinical Trial Site 100709
  • Chiesi Clinical Trial Site 100719
  • Chiesi Clinical Trial Site 100706
  • Chiesi Clinical Trial Site 100712
  • Chiesi Clinical Trial Site 100710
  • Chiesi Clinical Trial Site 100711
  • Chiesi Clinical Trial Site 100721
  • Chiesi Clinical Trial Site 203711
  • Chiesi Clinical Trial Site 203702
  • Chiesi Clinical Trial Site 203708
  • Chiesi Clinical Trial Site 203707
  • Chiesi Clinical Trial Site 203705
  • Chiesi Clinical Trial Site 203709
  • Chiesi Clinical Trial Site 203704
  • Chiesi Clinical Trial Site 203701
  • Chiesi Clinical Trial Site 203703
  • Chiesi Clinical Trial Site 203710
  • Chiesi Clinical Trial Site 203713
  • Chiesi Clinical Trial Site 203706
  • Chiesi Clinical Trial Site 203712
  • Chiesi Clinical Trial Site 276709
  • Chiesi Clinical Trial Site 276712
  • Chiesi Clinical Trial Site 276711
  • Chiesi Clinical Trial Site 276707
  • Chiesi Clinical Trial Site 276714
  • Chiesi Clinical Trial Site 276705
  • Chiesi Clinical Trial Site 276703
  • Chiesi Clinical Trial Site 276708
  • Chiesi Clinical Trial Site 276702
  • Chiesi Clinical Trial Site 276704
  • Chiesi Clinical Trial Site 276710
  • Chiesi Clinical Trial Site 276715
  • Chiesi Clinical Trial Site 276701
  • Chiesi Clinical Trial Site 276713
  • Chiesi Clinical Trial Site 276716
  • Chiesi Clinical Trial Site 348707
  • Chiesi Clinical Trial Site 348715
  • Chiesi Clinical Trial Site 348721
  • Chiesi Clinical Trial Site 348712
  • Chiesi Clinical Trial Site 348718
  • Chiesi Clinical Trial Site 348717
  • Chiesi Clinical Trial Site 348709
  • Chiesi Clinical Trial Site 348703
  • Chiesi Clinical Trial Site 348719
  • Chiesi Clinical Trial Site 348704
  • Chiesi Clinical Trial Site 348714
  • Chiesi Clinical Trial Site 348713
  • Chiesi Clinical Trial Site 348702
  • Chiesi Clinical Trial Site 348706
  • Chiesi Clinical Trial Site 348701
  • Chiesi Clinical Trial Site 348705
  • Chiesi Clinical Trial Site 348720
  • Chiesi Clinical Trial Site 348710
  • Chiesi Clinical Trial Site 348708
  • Chiesi Clinical Trial Site 380704
  • Chiesi Clinical Trial Site 380703
  • Chiesi Clinical Trial Site 380701
  • Chiesi Clinical Trial Site 380705
  • Chiesi Clinical Trial Site 380702
  • Chiesi Clinical Trial Site 380706
  • Chiesi Clinical Trial Site 440702
  • Chiesi Clinical Trial Site 440703
  • Chiesi Clinical Trial Site 440705
  • Chiesi Clinical Trial Site 440701
  • Chiesi Clinical Trial Site 616713
  • Chiesi Clinical Trial Site 616718
  • Chiesi Clinical Trial Site 616722
  • Chiesi Clinical Trial Site 616702
  • Chiesi Clinical Trial Site 616727
  • Chiesi Clinical Trial Site 616701
  • Chiesi Clinical Trial Site 616704
  • Chiesi Clinical Trial Site 616716
  • Chiesi Clinical Trial Site 616725
  • Chiesi Clinical Trial Site 616729
  • Chiesi Clinical Trial Site 616719
  • Chiesi Clinical Trial Site 616734
  • Chiesi Clinical Trial Site 616736
  • Chiesi Clinical Trial Site 616733
  • Chiesi Clinical Trial Site 616717
  • Chiesi Clinical Trial Site 616731
  • Chiesi Clinical Trial Site 616703
  • Chiesi Clinical Trial Site 616709
  • Chiesi Clinical Trial Site 616728
  • Chiesi Clinical Trial Site 616720
  • Chiesi Clinical Trial Site 616723
  • Chiesi Clinical Trial Site 616735
  • Chiesi Clinical Trial Site 616721
  • Chiesi Clinical Trial Site 616732
  • Chiesi Clinical Trial Site 616710
  • Chiesi Clinical Trial Site 616730
  • Chiesi Clinical Trial Site 616705
  • Chiesi Clinical Trial Site 616714
  • Chiesi Clinical Trial Site 616715
  • Chiesi Clinical Trial Site 616707
  • Chiesi Clinical Trial Site 616708
  • Chiesi Clinical Trial Site 616711
  • Chiesi Clinical Trial Site 616726
  • Chiesi Clinical Trial Site 616712
  • Chiesi Clinical Trial Site 620704
  • Chiesi Clinical Trial Site 620703
  • Chiesi Clinical Trial Site 620702
  • Chiesi Clinical Trial Site 620708
  • Chiesi Clinical Trial Site 620707
  • Chiesi Clinical Trial Site 642715
  • Chiesi Clinical Trial Site 642713
  • Chiesi Clinical Trial Site 642722
  • Chiesi Clinical Trial Site 642717
  • Chiesi Clinical Trial Site 642706
  • Chiesi Clinical Trial Site 642703
  • Chiesi Clinical Trial Site 642707
  • Chiesi Clinical Trial Site 642708
  • Chiesi Clinical Trial Site 642719
  • Chiesi Clinical Trial Site 642723
  • Chiesi Clinical Trial Site 642709
  • Chiesi Clinical Trial Site 642714
  • Chiesi Clinical Trial Site 642716
  • Chiesi Clinical Trial Site 642718
  • Chiesi Clinical Trial Site 642726
  • Chiesi Clinical Trial Site 642712
  • Chiesi Clinical Trial Site 642704
  • Chiesi Clinical Trial Site 642710
  • Chiesi Clinical Trial Site 642705
  • Chiesi Clinical Trial Site 642711
  • Chiesi Clinical Trial Site 642721
  • Chiesi Clinical Trial Site 643724
  • Chiesi Clinical Trial Site 643727
  • Chiesi Clinical Trial Site 643733
  • Chiesi Clinical Trial Site 643745
  • Chiesi Clinical Trial Site 643754
  • Chiesi Clinical Trial Site 643713
  • Chiesi Clinical Trial Site 643719
  • Chiesi Clinical Trial Site 643741
  • Chiesi Clinical Trial Site 643746
  • Chiesi Clinical Trial Site 643704
  • Chiesi Clinical Trial Site 643731
  • Chiesi Clinical Trial Site 643702
  • Chiesi Clinical Trial Site 643705
  • Chiesi Clinical Trial Site 643706
  • Chiesi Clinical Trial Site 643718
  • Chiesi Clinical Trial Site 643722
  • Chiesi Clinical Trial Site 643735
  • Chiesi Clinical Trial Site 643743
  • Chiesi Clinical Trial Site 643707
  • Chiesi Clinical Trial Site 643723
  • Chiesi Clinical Trial Site 643744
  • Chiesi Clinical Trial Site 643717
  • Chiesi Clinical Trial Site 643729
  • Chiesi Clinical Trial Site 643711
  • Chiesi Clinical Trial Site 643701
  • Chiesi Clinical Trial Site 643712
  • Chiesi Clinical Trial Site 643714
  • Chiesi Clinical Trial Site 643715
  • Chiesi Clinical Trial Site 643716
  • Chiesi Clinical Trial Site 643725
  • Chiesi Clinical Trial Site 643730
  • Chiesi Clinical Trial Site 643732
  • Chiesi Clinical Trial Site 643737
  • Chiesi Clinical Trial Site 643739
  • Chiesi Clinical Trial Site 643752
  • Chiesi Clinical Trial Site 643757
  • Chiesi Clinical Trial Site 643758
  • Chiesi Clinical Trial Site 643703
  • Chiesi Clinical Trial Site 643736
  • Chiesi Clinical Trial Site 643726
  • Chiesi Clinical Trial Site 643740
  • Chiesi Clinical Trial Site 643709
  • Chiesi Clinical Trial Site 643728
  • Chiesi Clinical Trial Site 643759
  • Chiesi Clinical Trial Site 643755
  • Chiesi Clinical Trial Site 643708
  • Chiesi Clinical Trial Site 643738
  • Chiesi Clinical Trial Site 643710
  • Chiesi Clinical Trial Site 643720
  • Chiesi Clinical Trial Site 643734
  • Chiesi Clinical Trial Site 643742
  • Chiesi Clinical Trial Site 643749
  • Chiesi Clinical Trial Site 643721
  • Chiesi Clinical Trial Site 703704
  • Chiesi Clinical Trial Site 703707
  • Chiesi Clinical Trial Site 703702
  • Chiesi Clinical Trial Site 703705
  • Chiesi Clinical Trial Site 703706
  • Chiesi Clinical Trial Site 703701
  • Chiesi Clinical Trial Site 703709
  • Chiesi Clinical Trial Site 703703
  • Chiesi Clinical Trial Site 703708
  • Chiesi Clinical Trial Site 724703
  • Chiesi Clinical Trial Site 724706
  • Chiesi Clinical Trial Site 724702
  • Chiesi Clinical Trial Site 724701
  • Chiesi Clinical Trial Site 724704
  • Chiesi Clinical Trial Site 724705
  • Chiesi Clinical Trial Site 724707
  • Chiesi Clinical Trial Site 792701
  • Chiesi Clinical Trial Site 792702
  • Chiesi Clinical Trial Site 792703
  • Chiesi Clinical Trial Site 792710
  • Chiesi Clinical Trial Site 792707
  • Chiesi Clinical Trial Site 792706
  • Chiesi Clinical Trial Site 792705
  • Chiesi Clinical Trial Site 792708
  • Chiesi Clinical Trial Site 792709
  • Chiesi Clinical Trial Site 804701
  • Chiesi Clinical Trial Site 804711
  • Chiesi Clinical Trial Site 804709
  • Chiesi Clinical Trial Site 804710
  • Chiesi Clinical Trial Site 804713
  • Chiesi Clinical Trial Site 804705
  • Chiesi Clinical Trial Site 804712
  • Chiesi Clinical Trial Site 804715
  • Chiesi Clinical Trial Site 804703
  • Chiesi Clinical Trial Site 804706
  • Chiesi Clinical Trial Site 804707
  • Chiesi Clinical Trial Site 804714
  • Chiesi Clinical Trial Site 804704
  • Chiesi Clinical Trial Site 804708
  • Chiesi Clinical Trial Site 826702
  • Chiesi Clinical Trial Site 826703
  • Chiesi Clinical Trial Site 826704
  • Chiesi Clinical Trial Site 826701

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CHF 5993 200/6/12.5 µg

CHF 1535 200/6 µg

CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg

Arm Description

Treatment A: CHF 5993 200/6/12.5 µg: 2 inhalations bid Total daily dose: 800/24/50 µg BDP/FF/GB

Treatment B: CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF

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

Outcomes

Primary Outcome Measures

Pre-dose FEV1 (Forced Expiratory Volume in the first second)
Reduction of moderate and severe asthma exacerbations rate

Secondary Outcome Measures

Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose
Change from baseline in morning PEF (Peak Expiratory Flow)
Reduction of severe asthma exacerbations rate
Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials

Full Information

First Posted
February 3, 2016
Last Updated
April 6, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02676089
Brief Title
TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Acronym
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2016 (Actual)
Primary Completion Date
May 28, 2018 (Actual)
Study Completion Date
May 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Anticholinergics, Triple combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1433 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5993 200/6/12.5 µg
Arm Type
Experimental
Arm Description
Treatment A: CHF 5993 200/6/12.5 µg: 2 inhalations bid Total daily dose: 800/24/50 µg BDP/FF/GB
Arm Title
CHF 1535 200/6 µg
Arm Type
Active Comparator
Arm Description
Treatment B: CHF 1535 200/6 µg: 2 inhalations bid Total daily dose: 800/24 µg BDP/FF
Arm Title
CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CHF 5993 200/6/12.5 µg
Intervention Type
Drug
Intervention Name(s)
CHF 1535 200/6 µg
Intervention Type
Drug
Intervention Name(s)
CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
Primary Outcome Measure Information:
Title
Pre-dose FEV1 (Forced Expiratory Volume in the first second)
Time Frame
Week 26
Title
Reduction of moderate and severe asthma exacerbations rate
Time Frame
Week 0 to Week 52
Secondary Outcome Measure Information:
Title
Peak FEV1 (Peak of Forced Expiratory Volume in the first second) within 3 hours post-dose
Time Frame
Week 26
Title
Change from baseline in morning PEF (Peak Expiratory Flow)
Time Frame
Week 0 to Week 26
Title
Reduction of severe asthma exacerbations rate
Description
Pooled analysis of CCD-05993AB1-03 and CCD-05993AB2-02 trials
Time Frame
Week 0 to week 52
Other Pre-specified Outcome Measures:
Title
Adverse Events and Adverse Drug reactions
Time Frame
Up to Week 52
Title
Collection of Health Economics outcomes
Description
Total use of healthcare resources and absence from work
Time Frame
Week 0 to Week 52

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing URL
https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Citations:
PubMed Identifier
31582314
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.
Results Reference
result
PubMed Identifier
35872377
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.
Results Reference
derived
PubMed Identifier
35450196
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.
Results Reference
derived
PubMed Identifier
33121501
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.
Results Reference
derived
PubMed Identifier
32430414
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.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000717-40/results
Description
Study Record on EU Clinical Trials Register including results.

Learn more about this trial

TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)

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