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Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)

Primary Purpose

COPD (Chronic Obstructive Pulmonary Disease)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CHF 5993 100/6/12.5 µg
160 µg budesonide + 4.5 µg formoterol fumarate
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD (Chronic Obstructive Pulmonary Disease) focused on measuring COPD, Anticholinergics, Triple Combination

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or Female adults aged > 40 years with a diagnosis of COPD
  • Current smokers or ex-smokers
  • A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI
  • At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of asthma, history of allergic rhinitis or atopy
  • Patients treated for exacerbations in the 4 weeks prior to screening visit
  • Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit
  • Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata
  • Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia
  • Known respiratory disorders other than COPD
  • Patients who have clinically significant cardiovascular condition

Sites / Locations

  • Chiesi clinical Trial Site 156031
  • Chiesi Clinical Trial Site 156026
  • Chiesi clinical Trial Site 156017
  • Chiesi Clinical Trial Site 156012
  • Chiesi Clinical Trial Site 156045
  • Chiesi Clinical Trial Site 156002
  • Chiesi clinical Trial Site 156024
  • Chiesi Clinical Trial Site 156048
  • Chiesi Clinical Trial Site 156013
  • The First Affiliated Hospital of Guangzhou Medical University site 156001
  • Chiesi Clinical Trial Site 156008
  • Chiesi Clinical Trial site 156003
  • Chiesi clinical Trial Site 156020
  • Chiesi Clinical Trial Site 156044
  • Chiesi Clinical Trial Site 156040
  • Chiesi Clinical Trial Site 156040
  • Chiesi Clinical Trial Site 156043
  • Chiesi Clinical Trial Site 156015
  • Chiesi Clinical Trial Site 156004
  • Chiesi clinical Trial Site 156033
  • Chiesi clinical Trial Site 156022
  • Chiesi Clinical Trial Site 156049
  • Chiesi Clinical Trial Site 156047
  • Chiesi Clinical Trial Site 156041
  • Chiesi clinical Trial Site 156028
  • Chiesi Clinical Trial Site 156042
  • Chiesi clinical Trial Site 156023
  • Chiesi Clinical Trial Site 156036
  • Chiesi clinical Trial Site 156019
  • Chiesi Clinical Trial Site 156007
  • Chiesi clinical Trial Site 156025
  • Chiesi Clinical Trial Site 156014
  • Chiesi clinical Trial Site 156037
  • Chiesi Clinical Trial Site 156005
  • Chiesi Clinical Trial Site 156006
  • Chiesi Clinical Trial Site 156011
  • Chiesi Clinical Trial Site 156038
  • Chiesi Clinical Trial Site 156039
  • Chiesi clinical Trial Site 156035
  • Chiesi Clinical Trial Site 156010
  • Chiesi clinical Trial Site 156032
  • Chiesi clinical Trial Site 156034
  • Chiesi clinical Trial Site 156018
  • Chiesi Clinical Trial Site 156046
  • Chiesi Clinical Trial Site 410003
  • Chiesi Clinical Trial Site 410012
  • Chiesi Clinical Trial Site 410001
  • Chiesi Clinical Trial Site 410002
  • Chiesi Clinical Trial Site 410005
  • Chiesi Clinical Trial Site 410008
  • Chiesi Clinical Trial Site 410007
  • Chiesi Clinical Trial Site 410004
  • Chiesi Clinical Trial Site 410006
  • Chiesi Clinical Trial Site 410009
  • Chiesi Clinical Trial Site 410010
  • Chiesi Clinical Trial Site 410011
  • Chiesi Clinical Trial Site 410013
  • Chiesi Clinical Trial Site 410014
  • Chiesi Clinical Trial Site 158001
  • Chiesi Clinical Trial Site 158004
  • Chiesi Clinical Trial Site 158010
  • Chiesi Clinical Trial Site 158003
  • Chiesi Clinical Trial Site 158010
  • Chiesi Clinical Trial Site 158006
  • Chiesi Clinical Trial Site 158008
  • Chiesi Clinical Trial Site 158005
  • Chiesi Clinical Trial Site 158011

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF 5993 100/6/12.5 µg

Symbicort Turbuhaler 160/4.5 µg

Arm Description

Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide)

Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)

Outcomes

Primary Outcome Measures

Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
Change from Baseline in 2-hour post-dose FEV1 at week 24
Change from Baseline in 2-hour post-dose FEV1 at week 24

Secondary Outcome Measures

Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24
Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose
Time to First COPD exacerbation
Time to First COPD exacerbation
Rate of COPD exacerbations
Rate of COPD exacerbations
Change in COPD Assessment Test (CAT)
Change in COPD Assessment Test (CAT)

Full Information

First Posted
January 25, 2017
Last Updated
March 30, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03197818
Brief Title
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
Acronym
TRIVERSYTI
Official Title
A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI (CHF 5993) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbuhaler®) in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
May 26, 2020 (Actual)
Study Completion Date
May 26, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD (Chronic Obstructive Pulmonary Disease)
Keywords
COPD, 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
990 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5993 100/6/12.5 µg
Arm Type
Experimental
Arm Description
Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide)
Arm Title
Symbicort Turbuhaler 160/4.5 µg
Arm Type
Active Comparator
Arm Description
Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)
Intervention Type
Drug
Intervention Name(s)
CHF 5993 100/6/12.5 µg
Intervention Description
Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose
Intervention Type
Drug
Intervention Name(s)
160 µg budesonide + 4.5 µg formoterol fumarate
Intervention Description
Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg
Primary Outcome Measure Information:
Title
Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
Description
Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
Time Frame
Baseline to Week 24
Title
Change from Baseline in 2-hour post-dose FEV1 at week 24
Description
Change from Baseline in 2-hour post-dose FEV1 at week 24
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24
Description
Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose
Time Frame
Baseline to Week 24
Title
Time to First COPD exacerbation
Description
Time to First COPD exacerbation
Time Frame
Baseline to week 24
Title
Rate of COPD exacerbations
Description
Rate of COPD exacerbations
Time Frame
Baseline to week 24
Title
Change in COPD Assessment Test (CAT)
Description
Change in COPD Assessment Test (CAT)
Time Frame
At all visits (from baseline to Week 24)
Other Pre-specified Outcome Measures:
Title
Adverse Events and Adverse Drug reactions
Description
Adverse Events and Adverse Drug reactions
Time Frame
Screening up to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female adults aged > 40 years with a diagnosis of COPD Current smokers or ex-smokers A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI At least one exacerbation in the 12 months preceding the screening visit Exclusion Criteria: Pregnant or lactating women Diagnosis of asthma, history of allergic rhinitis or atopy Patients treated for exacerbations in the 4 weeks prior to screening visit Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia Known respiratory disorders other than COPD Patients who have clinically significant cardiovascular condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinping Zheng
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiesi clinical Trial Site 156031
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Chiesi Clinical Trial Site 156026
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Chiesi clinical Trial Site 156017
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Chiesi Clinical Trial Site 156012
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100144
Country
China
Facility Name
Chiesi Clinical Trial Site 156045
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Facility Name
Chiesi Clinical Trial Site 156002
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Chiesi clinical Trial Site 156024
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Chiesi Clinical Trial Site 156048
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Chiesi Clinical Trial Site 156013
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University site 156001
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Chiesi Clinical Trial Site 156008
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524000
Country
China
Facility Name
Chiesi Clinical Trial site 156003
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Chiesi clinical Trial Site 156020
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570100
Country
China
Facility Name
Chiesi Clinical Trial Site 156044
City
Shijiangzhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Chiesi Clinical Trial Site 156040
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Chiesi Clinical Trial Site 156040
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Chiesi Clinical Trial Site 156043
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014000
Country
China
Facility Name
Chiesi Clinical Trial Site 156015
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
Chiesi Clinical Trial Site 156004
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Facility Name
Chiesi clinical Trial Site 156033
City
Jiangyin
State/Province
Jiangsu
ZIP/Postal Code
320281
Country
China
Facility Name
Chiesi clinical Trial Site 156022
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Facility Name
Chiesi Clinical Trial Site 156049
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
Chiesi Clinical Trial Site 156047
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
Chiesi Clinical Trial Site 156041
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
Chiesi clinical Trial Site 156028
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Chiesi Clinical Trial Site 156042
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337000
Country
China
Facility Name
Chiesi clinical Trial Site 156023
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Chiesi Clinical Trial Site 156036
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
Chiesi clinical Trial Site 156019
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Chiesi Clinical Trial Site 156007
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Chiesi clinical Trial Site 156025
City
YinChuan
State/Province
Ningxia
ZIP/Postal Code
750000
Country
China
Facility Name
Chiesi Clinical Trial Site 156014
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Chiesi clinical Trial Site 156037
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Chiesi Clinical Trial Site 156005
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Chiesi Clinical Trial Site 156006
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Chiesi Clinical Trial Site 156011
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Chiesi Clinical Trial Site 156038
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
210009
Country
China
Facility Name
Chiesi Clinical Trial Site 156039
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Chiesi clinical Trial Site 156035
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
Chiesi Clinical Trial Site 156010
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Chiesi clinical Trial Site 156032
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400000
Country
China
Facility Name
Chiesi clinical Trial Site 156034
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Chiesi clinical Trial Site 156018
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Chiesi Clinical Trial Site 156046
City
Linhai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
Chiesi Clinical Trial Site 410003
City
Chuncheon
State/Province
Gang'weondo
ZIP/Postal Code
24289
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410012
City
Bucheon-si
State/Province
Gyeonggido
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410001
City
Bucheon
State/Province
Gyeonggido
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410002
City
Goyang-si
State/Province
Gyeonggido
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410005
City
Jeonju
State/Province
Jeonrabugdo
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410008
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
07345
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410007
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410004
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
100-032
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410006
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410009
City
Gyeonggi-do
State/Province
Seoul Teugbyeols
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410010
City
Daegu
State/Province
Ulsan
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410011
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410013
City
Seoul
ZIP/Postal Code
2559
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 410014
City
Seoul
ZIP/Postal Code
5030
Country
Korea, Republic of
Facility Name
Chiesi Clinical Trial Site 158001
City
Keelung
State/Province
Keelung Municipality
ZIP/Postal Code
204
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158004
City
Kaohsiung
State/Province
Penghu
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158010
City
Changhua
State/Province
Taiwan Province
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158003
City
Douliu
State/Province
Yunlin
ZIP/Postal Code
64041
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158010
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158006
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158008
City
Taichung
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158005
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chiesi Clinical Trial Site 158011
City
Taipei
ZIP/Postal Code
220
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33757520
Citation
Zheng J, Baldi S, Zhao L, Li H, Lee KH, Singh D, Papi A, Grapin F, Guasconi A, Georges G. Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial. Respir Res. 2021 Mar 23;22(1):90. doi: 10.1186/s12931-021-01683-2.
Results Reference
result

Learn more about this trial

Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)

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