Clinical trial NCT03197818: Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Keywords: COPD
Anticholinergics
Triple Combination
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 990
Sex: ALL
Minimum age (years): 40
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 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.


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

Primary outcomes:
measure: Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
timeFrame: Baseline to Week 24
measure: Change from Baseline in 2-hour post-dose FEV1 at week 24
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24
timeFrame: Baseline to Week 24
measure: Time to First COPD exacerbation
timeFrame: Baseline to week 24
measure: Rate of COPD exacerbations
timeFrame: Baseline to week 24
measure: Change in COPD Assessment Test (CAT)
timeFrame: At all visits (from baseline to Week 24)
Other outcomes:
measure: Adverse Events and Adverse Drug reactions
timeFrame: Screening up to week 24
Locations:
city: Beijing
country: China
facility: Chiesi clinical Trial Site 156031
state: Beijing
city: Beijing
country: China
facility: Chiesi Clinical Trial Site 156026
state: Beijing
city: Beijing
country: China
facility: Chiesi clinical Trial Site 156017
state: Beijing
city: Beijing
country: China
facility: Chiesi Clinical Trial Site 156012
state: Beijing
city: Chongqing
country: China
facility: Chiesi Clinical Trial Site 156045
state: Chongqing
city: Fuzhou
country: China
facility: Chiesi Clinical Trial Site 156002
state: Fujian
city: Foshan
country: China
facility: Chiesi clinical Trial Site 156024
state: Guangdong
city: Guangzhou
country: China
facility: Chiesi Clinical Trial Site 156048
state: Guangdong
city: Guangzhou
country: China
facility: Chiesi Clinical Trial Site 156013
state: Guangdong
city: Guanzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University site 156001
state: Guangdong
city: Zhanjiang
country: China
facility: Chiesi Clinical Trial Site 156008
state: Guangdong
city: Nanning
country: China
facility: Chiesi Clinical Trial site 156003
state: Guangxi
city: Haikou
country: China
facility: Chiesi clinical Trial Site 156020
state: Hainan
city: Shijiangzhuang
country: China
facility: Chiesi Clinical Trial Site 156044
state: Hebei
city: Changsha
country: China
facility: Chiesi Clinical Trial Site 156040
state: Hunan
city: Changsha
country: China
facility: Chiesi Clinical Trial Site 156040
state: Hunan
city: Baotou
country: China
facility: Chiesi Clinical Trial Site 156043
state: Inner Mongolia
city: Baotou
country: China
facility: Chiesi Clinical Trial Site 156015
state: Inner Mongolia
city: Huai'an
country: China
facility: Chiesi Clinical Trial Site 156004
state: Jiangsu
city: Jiangyin
country: China
facility: Chiesi clinical Trial Site 156033
state: Jiangsu
city: Nanjing
country: China
facility: Chiesi clinical Trial Site 156022
state: Jiangsu
city: Suzhou
country: China
facility: Chiesi Clinical Trial Site 156049
state: Jiangsu
city: Jiujiang
country: China
facility: Chiesi Clinical Trial Site 156047
state: Jiangxi
city: Nanchang
country: China
facility: Chiesi Clinical Trial Site 156041
state: Jiangxi
city: Nanchang
country: China
facility: Chiesi clinical Trial Site 156028
state: Jiangxi
city: Pingxiang
country: China
facility: Chiesi Clinical Trial Site 156042
state: Jiangxi
city: Changchun
country: China
facility: Chiesi clinical Trial Site 156023
state: Jilin
city: Changchun
country: China
facility: Chiesi Clinical Trial Site 156036
state: Jilin
city: Changchun
country: China
facility: Chiesi clinical Trial Site 156019
state: Jilin
city: Shenyang
country: China
facility: Chiesi Clinical Trial Site 156007
state: Liaoning
city: YinChuan
country: China
facility: Chiesi clinical Trial Site 156025
state: Ningxia
city: Shanghai
country: China
facility: Chiesi Clinical Trial Site 156014
state: Shanghai
city: Shanghai
country: China
facility: Chiesi clinical Trial Site 156037
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial Site 156005
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial Site 156006
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial Site 156011
state: Shanghai
city: Shanghai
country: China
facility: Chiesi Clinical Trial Site 156038
state: Shanghai
city: Taiyuan
country: China
facility: Chiesi Clinical Trial Site 156039
state: Shanxi
city: Chengdu
country: China
facility: Chiesi clinical Trial Site 156035
state: Sichuan
city: Chengdu
country: China
facility: Chiesi Clinical Trial Site 156010
state: Sichuan
city: Chongqing
country: China
facility: Chiesi clinical Trial Site 156032
state: Sichuan
city: Tianjin
country: China
facility: Chiesi clinical Trial Site 156034
state: Tianjin
city: Hangzhou
country: China
facility: Chiesi clinical Trial Site 156018
state: Zhejiang
city: Linhai
country: China
facility: Chiesi Clinical Trial Site 156046
state: Zhejiang
city: Chuncheon
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410003
state: Gang'weondo
city: Bucheon-si
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410012
state: Gyeonggido
city: Bucheon
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410001
state: Gyeonggido
city: Goyang-si
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410002
state: Gyeonggido
city: Jeonju
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410005
state: Jeonrabugdo
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410008
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410007
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410004
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410006
state: Seoul Teugbyeolsi
city: Gyeonggi-do
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410009
state: Seoul Teugbyeols
city: Daegu
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410010
state: Ulsan
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410011
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410013
city: Seoul
country: Korea, Republic of
facility: Chiesi Clinical Trial Site 410014
city: Keelung
country: Taiwan
facility: Chiesi Clinical Trial Site 158001
state: Keelung Municipality
city: Kaohsiung
country: Taiwan
facility: Chiesi Clinical Trial Site 158004
state: Penghu
city: Changhua
country: Taiwan
facility: Chiesi Clinical Trial Site 158010
state: Taiwan Province
city: Douliu
country: Taiwan
facility: Chiesi Clinical Trial Site 158003
state: Yunlin
city: Changhua
country: Taiwan
facility: Chiesi Clinical Trial Site 158010
city: Kaohsiung
country: Taiwan
facility: Chiesi Clinical Trial Site 158006
city: Taichung
country: Taiwan
facility: Chiesi Clinical Trial Site 158008
city: Taipei
country: Taiwan
facility: Chiesi Clinical Trial Site 158005
city: Taipei
country: Taiwan
facility: Chiesi Clinical Trial Site 158011
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Jinping Zheng
role: PRINCIPAL_INVESTIGATOR
References:
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.