Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient

Chronic Obstructive Pulmonary Disease Clinical Trial

— FORSYYN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888131
• Other study ID #: CCD-01535AC1-02
• Status: Completed
• Phase: Phase 3
• Start date: July 30, 2018
• Est. completion date: May 6, 2022

Study information

• Verified date: July 2022
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: May 6, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo
Fixed combination of beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg (BDP/FF)
• Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo
Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (BUD/FF)

Locations

Country	Name	City	State
China	Site 15611 - Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Site 15612 - Beijing Tong Ren Hospital, Capital Medical University	Beijing	Beijing
China	Site 15613 - Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Site 15626 - Peking University Third Hospital	Beijing	Beijing
China	Site 15640 - Peking University Shougang Hospital	Beijing	Beijing
China	Site 15643 - No.2 Hospital Affiliated to Jilin University	Changchun	Jilin
China	Site 15658 - Jilin Province People's Hospital	Changchun	Jilin
China	Site 15622 - The Third Hospital of Changsha	Changsha	Hunan
China	Site 15605 - West China Hospital, Sichuan University	Chengdu	Sichuan
China	Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District	Chongqing	Chongqing
China	Site 15634 - Chongqing General Hospital	Chongqing	Chongqing
China	Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning
China	Site 15630 - Dongguan People's Hospital	Dongguan	Guangdong
China	Site 15607 - The First People's Hospital of Shunde	Foshan	Guangdong
China	Site 15636 - Fujian Province Hospital	Fuzhou	Fujian
China	Site 15608 - The First Affiliated Hospital Sun Yat-sen University	Guangzhou	Guangdong
China	Site 15614 - Guangzhou Panyu central hospital	Guangzhou	Guangdong
China	Site 15619 - The Third Affiliated Hospital of Southern Medical University	Guangzhou	Guangdong
China	Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Site 15651 - The Second Xiangya Hospital of Central South University	Guangzhou	Guangdong
China	Site 15623 - Haikou People's Hospital	Haikou	Hainan
China	Site 15645 - Hainan General Hospital	Haikou	Hainan
China	Site 15602 - Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Site 15604 - Anhui Provincial Hospital	Hefei	Anhui
China	Site 15635 - The Second Hospital of Anhui Medical Hospital	Hefei	Anhui
China	Site 15647 - The Second hospital. University of South China	Hengyang	Hunan
China	Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Site 15644 - Jinan Central Hospital	Jinan	Shandong
China	Site 15650 - The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Site 15659 - Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Site 15627 - Nanjing Medical University Affiliated 2nd Hospital	Nanjing	Jiangsu
China	Site 15657 - Zhong Da Hospital, Southeast University	Nanjing	Jiangsu
China	Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Site 15601 - Huadong Hospital Afflilliated to Fudan University	Shanghai	Shanghai
China	Site 15606 - Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Site 15625 - Central Hospital of Shanghai Minhang District	Shanghai	Shanghai
China	Site 15628 - Shanghai Xuhui Center Hospital	Shanghai	Shanghai
China	Site 15629 - Shanghai East Hospital	Shanghai	Shanghai
China	Site 15631 - Shanghai Yangpu District Centre Hospital	Shanghai	Shanghai
China	Site 15638 - Second Hospital of Shanxi Medical	Taiyuan	Shanxi
China	Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Site 15642 - Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Site 15609 - Tianjin First Center Hospital	Tianjin	Tianjin
China	Site 15633 - Tianjin Haihe Hospital	Tianjin	Tianjin
China	Site 15639 -The second Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Site 15621 - Wuxi People's Hospital	Wuxi	Jiangsu
China	Site 15653 - Xiangtan Central Hospital	Xiangtan	Hunan
China	Site 15632 - Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Site 15618 - Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Site 15617 - Henan Provincial Chest Hospital	Zhengzhou	Henan
China	Site 15654 - Henan Provincial People's Hospital	Zhengzhou	Henan
China	Site 15637 - Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of the non-inferiority of CHF 1535 pMDI versus Symbicort® Turbohaler® in terms of pulmonary function	Change from baseline in pre-dose morning First Expiratory Volume in 1 second (FEV1) in patients with Chronic Obstructive Pulmonary Disease (COPD)	At week 24
Secondary	Effect of CHF 1535 on change from baseline pre-dose morning FEV1	FEV1 is the volume of air that can be forced out in one second after taking a deep breath. FEV1 will be measured via spirometer.	At week 4, week 12, week 18 and week 24
Secondary	Effect of CHF 1535 on chnage from Baseline in pre-dose morning Force Vital Capacity (FVC)	FVC is the volume of air expired after a maximum inspiration. FVC will be measured via spirometer.	At week 4, week 12, week 18 and week 24
Secondary	Effect of CHF 1535 on change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total scores and domains	The SGRQ is a well-established, self-completed tool to measure impact on overall health, daily life and perceived well-being in patients with obstructive airways disease. Score range from 0 to 100 with higher scores indicating more limitations.	At week 12, week 24
Secondary	Effect of CHF 1535 on change from baseline in COPD Assessment Test (CAT)	CAT is an easy questionnaire self-administered by patients. It was specifically designed to measure candidate items regarding daily symptoms, activity limitations and other manifestations of the COPD. It will be filled in at all clinical visits.	Over 28 weeks
Secondary	Effect of CHF 1535 on the rate of COPD exacerbations	The number of moderate and severe COPD exacerbations during the treatment period will be collected and analyzed.; Moderate exacerbations require treatment with systemic corticosteroids and/or antibiotics; Severe exacerbations require hospitalisation or result in death	Over 24 weeks of treatment
Secondary	Number of patients with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An AE is "any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment".; A SAE is defined as any untoward medical occurrence or effect that, at any dose may result in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.	Over 29 weeks (from Visit 0 to Visit 6)
Secondary	Assessment of blood pressure	Systolic and diastolic blood pressure will be measured at all clinical visits from Visit 1 after 10 minutes in seated resting position.	Over 28 weeks (from Visit 1 to Visit 6)
Secondary	Number of subjects with abnormal Electrocardiogram (ECG) findings	Twelve-lead ECG measurements will be obtained after the subject laid in a resting position for 10 minutes. ECG will be recorded in triplicate and evaluated at Visit 1 and Visit 6.	At screening visit and week 24
Secondary	Number of subjects with abnormal Haematology parameters	The following Haematology parameters will be assessed by a central laboratory: Red blood cells count (RBC), white blood cells count (WBC) and differential, total haemoglobin (Hb), hematocrit (Hct), platelets count (PLT).	At screening visit and week 24
Secondary	Number of subjects with abnormal Blood Chemistry parameters	The following Blood Chemistry parameters will be assessed by a central laboratory: creatinine, BUN, fasting serum glucose, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma-glutamyl transpeptidase (?-GT), total bilirubin, alkaline phosphatase, sodium, potassium, calcium, and chloride electrolytes (Na, K, Ca, Cl), albumin.	At screening visit and week 24