Back to resultsFoster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo
Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Lung functions, COPD
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
Sites / Locations
- Site 15604 - Anhui Provincial Hospital
- Site 15635 - The Second Hospital of Anhui Medical Hospital
- Site 15613 - Beijing Friendship Hospital, Capital Medical University
- Site 15611 - Xuanwu Hospital Capital Medical University
- Site 15640 - Peking University Shougang Hospital
- Site 15626 - Peking University Third Hospital
- Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
- Site 15634 - Chongqing General Hospital
- Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
- Site 15636 - Fujian Province Hospital
- Site 15650 - The First Hospital of Lanzhou University
- Site 15630 - Dongguan People's Hospital
- Site 15607 - The First People's Hospital of Shunde
- Site 15619 - The Third Affiliated Hospital of Southern Medical University
- Site 15608 - The First Affiliated Hospital Sun Yat-sen University
- Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University
- Site 15651 - The Second Xiangya Hospital of Central South University
- Site 15614 - Guangzhou Panyu central hospital
- Site 15618 - Affiliated Hospital of Guangdong Medical University
- Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region
- Site 15637 - Affiliated Hospital of Zunyi Medical College
- Site 15623 - Haikou People's Hospital
- Site 15645 - Hainan General Hospital
- Site 15654 - Henan Provincial People's Hospital
- Site 15617 - Henan Provincial Chest Hospital
- Site 15622 - The Third Hospital of Changsha
- Site 15647 - The Second hospital. University of South China
- Site 15653 - Xiangtan Central Hospital
- Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University
- Site 15657 - Zhong Da Hospital, Southeast University
- Site 15627 - Nanjing Medical University Affiliated 2nd Hospital
- Site 15621 - Wuxi People's Hospital
- Site 15632 - Xuzhou Central Hospital
- Site 15659 - Jiangxi Provincial People's Hospital
- Site 15658 - Jilin Province People's Hospital
- Site 15643 - No.2 Hospital Affiliated to Jilin University
- Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University
- Site 15644 - Jinan Central Hospital
- Site 15629 - Shanghai East Hospital
- Site 15628 - Shanghai Xuhui Center Hospital
- Site 15601 - Huadong Hospital Afflilliated to Fudan University
- Site 15631 - Shanghai Yangpu District Centre Hospital
- Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine
- Site 15606 - Shanghai Pulmonary Hospital
- Site 15625 - Central Hospital of Shanghai Minhang District
- Site 15638 - Second Hospital of Shanxi Medical
- Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University
- Site 15605 - West China Hospital, Sichuan University
- Site 15609 - Tianjin First Center Hospital
- Site 15633 - Tianjin Haihe Hospital
- Site 15602 - Hangzhou First People's Hospital
- Site 15642 - Taizhou Hospital of Zhejiang Province
- Site 15639 -The second Affiliated Hospital of Wenzhou Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CHF 1535 100/6 µg pMDI
Symbicort® Turbohaler®
Arm Description
2 inhalations BID Total Daily Dose = 400/24µg
2 inhalations BID Total Daily Dose = 640/18µg
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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.
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.
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
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.
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.
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.
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).
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 (γ-GT), total bilirubin, alkaline phosphatase, sodium, potassium, calcium, and chloride electrolytes (Na, K, Ca, Cl), albumin.
Full Information
NCT ID
NCT03888131
First Posted
August 22, 2018
Last Updated
July 8, 2022
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT03888131
Brief Title
Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
May 6, 2022 (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
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Lung functions, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHF 1535 100/6 µg pMDI
Arm Type
Experimental
Arm Description
2 inhalations BID Total Daily Dose = 400/24µg
Arm Title
Symbicort® Turbohaler®
Arm Type
Active Comparator
Arm Description
2 inhalations BID Total Daily Dose = 640/18µg
Intervention Type
Drug
Intervention Name(s)
CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo
Intervention Description
Fixed combination of beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg (BDP/FF)
Intervention Type
Drug
Intervention Name(s)
Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo
Intervention Description
Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (BUD/FF)
Primary Outcome Measure Information:
Title
Demonstration of the non-inferiority of CHF 1535 pMDI versus Symbicort® Turbohaler® in terms of pulmonary function
Description
Change from baseline in pre-dose morning First Expiratory Volume in 1 second (FEV1) in patients with Chronic Obstructive Pulmonary Disease (COPD)
Time Frame
At week 24
Secondary Outcome Measure Information:
Title
Effect of CHF 1535 on change from baseline pre-dose morning FEV1
Description
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.
Time Frame
At week 4, week 12, week 18 and week 24
Title
Effect of CHF 1535 on chnage from Baseline in pre-dose morning Force Vital Capacity (FVC)
Description
FVC is the volume of air expired after a maximum inspiration. FVC will be measured via spirometer.
Time Frame
At week 4, week 12, week 18 and week 24
Title
Effect of CHF 1535 on change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total scores and domains
Description
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.
Time Frame
At week 12, week 24
Title
Effect of CHF 1535 on change from baseline in COPD Assessment Test (CAT)
Description
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.
Time Frame
Over 28 weeks
Title
Effect of CHF 1535 on the rate of COPD exacerbations
Description
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
Time Frame
Over 24 weeks of treatment
Title
Number of patients with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Over 29 weeks (from Visit 0 to Visit 6)
Title
Assessment of blood pressure
Description
Systolic and diastolic blood pressure will be measured at all clinical visits from Visit 1 after 10 minutes in seated resting position.
Time Frame
Over 28 weeks (from Visit 1 to Visit 6)
Title
Number of subjects with abnormal Electrocardiogram (ECG) findings
Description
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.
Time Frame
At screening visit and week 24
Title
Number of subjects with abnormal Haematology parameters
Description
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).
Time Frame
At screening visit and week 24
Title
Number of subjects with abnormal Blood Chemistry parameters
Description
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 (γ-GT), total bilirubin, alkaline phosphatase, sodium, potassium, calcium, and chloride electrolytes (Na, K, Ca, Cl), albumin.
Time Frame
At screening visit and week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Fuqiang WEN, M.D., Ph.D.
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 15604 - Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Site 15635 - The Second Hospital of Anhui Medical Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
231200
Country
China
Facility Name
Site 15613 - Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Site 15611 - Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Site 15640 - Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100144
Country
China
Facility Name
Site 15626 - Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Site 15634 - Chongqing General Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400013
Country
China
Facility Name
Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400020
Country
China
Facility Name
Site 15636 - Fujian Province Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Site 15650 - The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730000
Country
China
Facility Name
Site 15630 - Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523059
Country
China
Facility Name
Site 15607 - The First People's Hospital of Shunde
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528300
Country
China
Facility Name
Site 15619 - The Third Affiliated Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Site 15608 - The First Affiliated Hospital Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510030
Country
China
Facility Name
Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
Site 15651 - The Second Xiangya Hospital of Central South University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
Site 15614 - Guangzhou Panyu central hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511400
Country
China
Facility Name
Site 15618 - Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524000
Country
China
Facility Name
Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Site 15637 - Affiliated Hospital of Zunyi Medical College
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563099
Country
China
Facility Name
Site 15623 - Haikou People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570208
Country
China
Facility Name
Site 15645 - Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Site 15654 - Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Site 15617 - Henan Provincial Chest Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Site 15622 - The Third Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410015
Country
China
Facility Name
Site 15647 - The Second hospital. University of South China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Site 15653 - Xiangtan Central Hospital
City
Xiangtan
State/Province
Hunan
ZIP/Postal Code
411100
Country
China
Facility Name
Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
Facility Name
Site 15657 - Zhong Da Hospital, Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Site 15627 - Nanjing Medical University Affiliated 2nd Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Site 15621 - Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
241023
Country
China
Facility Name
Site 15632 - Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Facility Name
Site 15659 - Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Site 15658 - Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Site 15643 - No.2 Hospital Affiliated to Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116033
Country
China
Facility Name
Site 15644 - Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Site 15629 - Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
2000120
Country
China
Facility Name
Site 15628 - Shanghai Xuhui Center Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Site 15601 - Huadong Hospital Afflilliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Site 15631 - Shanghai Yangpu District Centre Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200090
Country
China
Facility Name
Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Facility Name
Site 15606 - Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Site 15625 - Central Hospital of Shanghai Minhang District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201199
Country
China
Facility Name
Site 15638 - Second Hospital of Shanxi Medical
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
0300001
Country
China
Facility Name
Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
Site 15605 - West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Site 15609 - Tianjin First Center Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
Site 15633 - Tianjin Haihe Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300350
Country
China
Facility Name
Site 15602 - Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Site 15642 - Taizhou Hospital of Zhejiang Province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
Site 15639 -The second Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient
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