Clinical trial NCT03888131: Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient
Official title: A 24-week, Double Blind, Double Dummy, Randomized, Multicentre, 2-arm Parallel Group, Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI (CHF 1535) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbohaler®) in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Lung functions
COPD
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2019-03-25
Enrollment: 750
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 the study is to demonstrate the non-inferiority of CHF1535 pMDI versus Symbicort® Turbohaler® in terms of lung function parameters and patients reported outcomes and to assess its safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 40 years, Chinese ethnicity
* Patients with COPD diagnosed at least 12 months before the screening visit.
* A smoking history of at least 10 pack years
* Post-bronchodilator FEV1 \< 50% of the predicted normal value
* Post-bronchodilator FEV1/FVC ratio \< 0.7
* One exacerbation in the 12 months prior the screening visit

Exclusion Criteria:

* Patients requiring OCS/antibiotics/PDE inhibitors in the 4 weeks prior to screening
* COPD exacerbation requiring OCS/antibiotics or hospitalization during the run-in period
* Known respiratory disorders other than COPD
* Diagnosis of asthma

Primary outcomes:
measure: Demonstration of the non-inferiority of CHF 1535 pMDI versus Symbicort® Turbohaler® in terms of pulmonary function
timeFrame: At week 24
Secondary outcomes:
measure: Effect of CHF 1535 on change from baseline pre-dose morning FEV1
timeFrame: At week 4, week 12, week 18 and week 24
measure: Effect of CHF 1535 on chnage from Baseline in pre-dose morning Force Vital Capacity (FVC)
timeFrame: At week 4, week 12, week 18 and week 24
measure: Effect of CHF 1535 on change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total scores and domains
timeFrame: At week 12, week 24
measure: Effect of CHF 1535 on change from baseline in COPD Assessment Test (CAT)
timeFrame: Over 28 weeks
measure: Effect of CHF 1535 on the rate of COPD exacerbations
timeFrame: Over 24 weeks of treatment
measure: Number of patients with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Over 29 weeks (from Visit 0 to Visit 6)
measure: Assessment of blood pressure
timeFrame: Over 28 weeks (from Visit 1 to Visit 6)
measure: Number of subjects with abnormal Electrocardiogram (ECG) findings
timeFrame: At screening visit and week 24
measure: Number of subjects with abnormal Haematology parameters
timeFrame: At screening visit and week 24
measure: Number of subjects with abnormal Blood Chemistry parameters
timeFrame: At screening visit and week 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: Site 15604 - Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: Site 15635 - The Second Hospital of Anhui Medical Hospital
state: Anhui
city: Beijing
country: China
facility: Site 15613 - Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Site 15611 - Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Site 15640 - Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: Site 15626 - Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Site 15634 - Chongqing General Hospital
state: Chongqing
city: Chongqing
country: China
facility: Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
state: Chongqing
city: Fuzhou
country: China
facility: Site 15636 - Fujian Province Hospital
state: Fujian
city: Lanzhou
country: China
facility: Site 15650 - The First Hospital of Lanzhou University
state: Gansu
city: Dongguan
country: China
facility: Site 15630 - Dongguan People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Site 15607 - The First People's Hospital of Shunde
state: Guangdong
city: Guangzhou
country: China
facility: Site 15619 - The Third Affiliated Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Site 15608 - The First Affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Site 15651 - The Second Xiangya Hospital of Central South University
state: Guangdong
city: Guangzhou
country: China
facility: Site 15614 - Guangzhou Panyu central hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Site 15618 - Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Nanning
country: China
facility: Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Zunyi
country: China
facility: Site 15637 - Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Haikou
country: China
facility: Site 15623 - Haikou People's Hospital
state: Hainan
city: Haikou
country: China
facility: Site 15645 - Hainan General Hospital
state: Hainan
city: Zhengzhou
country: China
facility: Site 15654 - Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: Site 15617 - Henan Provincial Chest Hospital
state: Henan
city: Changsha
country: China
facility: Site 15622 - The Third Hospital of Changsha
state: Hunan
city: Hengyang
country: China
facility: Site 15647 - The Second hospital. University of South China
state: Hunan
city: Xiangtan
country: China
facility: Site 15653 - Xiangtan Central Hospital
state: Hunan
city: Hohhot
country: China
facility: Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Site 15657 - Zhong Da Hospital, Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Site 15627 - Nanjing Medical University Affiliated 2nd Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Site 15621 - Wuxi People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Site 15632 - Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Site 15659 - Jiangxi Provincial People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Site 15658 - Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: Site 15643 - No.2 Hospital Affiliated to Jilin University
state: Jilin
city: Dalian
country: China
facility: Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University
state: Liaoning
city: Jinan
country: China
facility: Site 15644 - Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Site 15629 - Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Site 15628 - Shanghai Xuhui Center Hospital
state: Shanghai
city: Shanghai
country: China
facility: Site 15601 - Huadong Hospital Afflilliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Site 15631 - Shanghai Yangpu District Centre Hospital
state: Shanghai
city: Shanghai
country: China
facility: Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Site 15606 - Shanghai Pulmonary Hospital
state: Shanghai
city: Shanghai
country: China
facility: Site 15625 - Central Hospital of Shanghai Minhang District
state: Shanghai
city: Taiyuan
country: China
facility: Site 15638 - Second Hospital of Shanxi Medical
state: Shanxi
city: Taiyuan
country: China
facility: Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Site 15605 - West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Site 15609 - Tianjin First Center Hospital
state: Tianjin
city: Tianjin
country: China
facility: Site 15633 - Tianjin Haihe Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Site 15602 - Hangzhou First People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Site 15642 - Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: Site 15639 -The second Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: West China Hospital
name: Professor Fuqiang WEN, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wen F, Wu Y, Xing C, Zhu Y, Chen Y, Mei X, Corradi M, Cappellini G, Calabro E, Amodio S, Zhu C, Galkin D. Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study. COPD. 2024 Dec;21(1):2425157. doi: 10.1080/15412555.2024.2425157. Epub 2024 Nov 11.