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NCT03197818 Clinical Trial

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

COPD (Chronic Obstructive Pulmonary Disease) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03197818
Other study ID # CCD-5993AA1-14
Secondary ID ChinaTaiwanSouth
Status Completed
Phase Phase 3
First received
Last updated
Start date December 14, 2016
Est. completion date May 26, 2020

Study information
Verified date March 2021
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 990
Est. completion date May 26, 2020
Est. primary completion date May 26, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CHF 5993 100/6/12.5 µg
Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose
• 160 µg budesonide + 4.5 µg formoterol fumarate
Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg

Locations
Country Name City State
China Chiesi Clinical Trial Site 156015 Baotou Inner Mongolia
China Chiesi Clinical Trial Site 156043 Baotou Inner Mongolia
China Chiesi Clinical Trial Site 156012 Beijing Beijing
China Chiesi clinical Trial Site 156017 Beijing Beijing
China Chiesi Clinical Trial Site 156026 Beijing Beijing
China Chiesi clinical Trial Site 156031 Beijing Beijing
China Chiesi clinical Trial Site 156019 Changchun Jilin
China Chiesi clinical Trial Site 156023 Changchun Jilin
China Chiesi Clinical Trial Site 156036 Changchun Jilin
China Chiesi Clinical Trial Site 156040 Changsha Hunan
China Chiesi Clinical Trial Site 156040 Changsha Hunan
China Chiesi Clinical Trial Site 156010 Chengdu Sichuan
China Chiesi clinical Trial Site 156035 Chengdu Sichuan
China Chiesi clinical Trial Site 156032 Chongqing Sichuan
China Chiesi Clinical Trial Site 156045 Chongqing Chongqing
China Chiesi clinical Trial Site 156024 Foshan Guangdong
China Chiesi Clinical Trial Site 156002 Fuzhou Fujian
China Chiesi Clinical Trial Site 156013 Guangzhou Guangdong
China Chiesi Clinical Trial Site 156048 Guangzhou Guangdong
China The First Affiliated Hospital of Guangzhou Medical University site 156001 Guanzhou Guangdong
China Chiesi clinical Trial Site 156020 Haikou Hainan
China Chiesi clinical Trial Site 156018 Hangzhou Zhejiang
China Chiesi Clinical Trial Site 156004 Huai'an Jiangsu
China Chiesi clinical Trial Site 156033 Jiangyin Jiangsu
China Chiesi Clinical Trial Site 156047 Jiujiang Jiangxi
China Chiesi Clinical Trial Site 156046 Linhai Zhejiang
China Chiesi clinical Trial Site 156028 Nanchang Jiangxi
China Chiesi Clinical Trial Site 156041 Nanchang Jiangxi
China Chiesi clinical Trial Site 156022 Nanjing Jiangsu
China Chiesi Clinical Trial site 156003 Nanning Guangxi
China Chiesi Clinical Trial Site 156042 Pingxiang Jiangxi
China Chiesi Clinical Trial Site 156005 Shanghai Shanghai
China Chiesi Clinical Trial Site 156006 Shanghai Shanghai
China Chiesi Clinical Trial Site 156011 Shanghai Shanghai
China Chiesi Clinical Trial Site 156014 Shanghai Shanghai
China Chiesi clinical Trial Site 156037 Shanghai Shanghai
China Chiesi Clinical Trial Site 156038 Shanghai Shanghai
China Chiesi Clinical Trial Site 156007 Shenyang Liaoning
China Chiesi Clinical Trial Site 156044 Shijiangzhuang Hebei
China Chiesi Clinical Trial Site 156049 Suzhou Jiangsu
China Chiesi Clinical Trial Site 156039 Taiyuan Shanxi
China Chiesi clinical Trial Site 156034 Tianjin Tianjin
China Chiesi clinical Trial Site 156025 YinChuan Ningxia
China Chiesi Clinical Trial Site 156008 Zhanjiang Guangdong
Korea, Republic of Chiesi Clinical Trial Site 410001 Bucheon Gyeonggido
Korea, Republic of Chiesi Clinical Trial Site 410012 Bucheon-si Gyeonggido
Korea, Republic of Chiesi Clinical Trial Site 410003 Chuncheon Gang'weondo
Korea, Republic of Chiesi Clinical Trial Site 410010 Daegu Ulsan
Korea, Republic of Chiesi Clinical Trial Site 410002 Goyang-si Gyeonggido
Korea, Republic of Chiesi Clinical Trial Site 410009 Gyeonggi-do Seoul Teugbyeols
Korea, Republic of Chiesi Clinical Trial Site 410005 Jeonju Jeonrabugdo
Korea, Republic of Chiesi Clinical Trial Site 410004 Seoul Seoul Teugbyeolsi
Korea, Republic of Chiesi Clinical Trial Site 410006 Seoul Seoul Teugbyeolsi
Korea, Republic of Chiesi Clinical Trial Site 410007 Seoul Seoul Teugbyeolsi
Korea, Republic of Chiesi Clinical Trial Site 410008 Seoul Seoul Teugbyeolsi
Korea, Republic of Chiesi Clinical Trial Site 410011 Seoul
Korea, Republic of Chiesi Clinical Trial Site 410013 Seoul
Korea, Republic of Chiesi Clinical Trial Site 410014 Seoul
Taiwan Chiesi Clinical Trial Site 158010 Changhua
Taiwan Chiesi Clinical Trial Site 158010 Changhua Taiwan Province
Taiwan Chiesi Clinical Trial Site 158003 Douliu Yunlin
Taiwan Chiesi Clinical Trial Site 158004 Kaohsiung Penghu
Taiwan Chiesi Clinical Trial Site 158006 Kaohsiung
Taiwan Chiesi Clinical Trial Site 158001 Keelung Keelung Municipality
Taiwan Chiesi Clinical Trial Site 158008 Taichung
Taiwan Chiesi Clinical Trial Site 158005 Taipei
Taiwan Chiesi Clinical Trial Site 158011 Taipei

Sponsors (1)
Lead Sponsor Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Adverse Events and Adverse Drug reactions Adverse Events and Adverse Drug reactions Screening up to week 24
Primary 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 Baseline to Week 24
Primary Change from Baseline in 2-hour post-dose FEV1 at week 24 Change from Baseline in 2-hour post-dose FEV1 at week 24 Baseline to Week 24
Secondary 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 Baseline to Week 24
Secondary Time to First COPD exacerbation Time to First COPD exacerbation Baseline to week 24
Secondary Rate of COPD exacerbations Rate of COPD exacerbations Baseline to week 24
Secondary Change in COPD Assessment Test (CAT) Change in COPD Assessment Test (CAT) At all visits (from baseline to Week 24)
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