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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo; Drug: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Site 15604 - Anhui Provincial Hospital
    • Hefei, Anhui, China, 231200
      • Site 15635 - The Second Hospital of Anhui Medical Hospital
  • Beijing
    • Beijing, Beijing, China, 100050
      • Site 15613 - Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100053
      • Site 15611 - Xuanwu Hospital Capital Medical University
    • Beijing, Beijing, China, 100144
      • Site 15640 - Peking University Shougang Hospital
    • Beijing, Beijing, China, 100191
      • Site 15626 - Peking University Third Hospital
    • Beijing, Beijing, China, 100730
      • Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400013
      • Site 15634 - Chongqing General Hospital
    • Chongqing, Chongqing, China, 400020
      • Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Site 15636 - Fujian Province Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Site 15650 - The First Hospital of Lanzhou University
  • Guangdong
    • Dongguan, Guangdong, China, 523059
      • Site 15630 - Dongguan People's Hospital
    • Foshan, Guangdong, China, 528300
      • Site 15607 - The First People's Hospital of Shunde
    • Guangzhou, Guangdong, China, 510000
      • Site 15619 - The Third Affiliated Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510030
      • Site 15608 - The First Affiliated Hospital Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510260
      • Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 510260
      • Site 15651 - The Second Xiangya Hospital of Central South University
    • Guangzhou, Guangdong, China, 511400
      • Site 15614 - Guangzhou Panyu central hospital
    • Zhanjiang, Guangdong, China, 524000
      • Site 15618 - Affiliated Hospital of Guangdong Medical University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region
  • Guizhou
    • Zunyi, Guizhou, China, 563099
      • Site 15637 - Affiliated Hospital of Zunyi Medical College
  • Hainan
    • Haikou, Hainan, China, 570208
      • Site 15623 - Haikou People's Hospital
    • Haikou, Hainan, China, 570311
      • Site 15645 - Hainan General Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Site 15654 - Henan Provincial People's Hospital
    • Zhengzhou, Henan, China, 450008
      • Site 15617 - Henan Provincial Chest Hospital
  • Hunan
    • Changsha, Hunan, China, 410015
      • Site 15622 - The Third Hospital of Changsha
    • Hengyang, Hunan, China, 421001
      • Site 15647 - The Second hospital. University of South China
    • Xiangtan, Hunan, China, 411100
      • Site 15653 - Xiangtan Central Hospital
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010050
      • Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Site 15657 - Zhong Da Hospital, Southeast University
    • Nanjing, Jiangsu, China, 210011
      • Site 15627 - Nanjing Medical University Affiliated 2nd Hospital
    • Wuxi, Jiangsu, China, 241023
      • Site 15621 - Wuxi People's Hospital
    • Xuzhou, Jiangsu, China, 221009
      • Site 15632 - Xuzhou Central Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Site 15659 - Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • Site 15658 - Jilin Province People's Hospital
    • Changchun, Jilin, China, 130041
      • Site 15643 - No.2 Hospital Affiliated to Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116033
      • Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Site 15644 - Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 2000120
      • Site 15629 - Shanghai East Hospital
    • Shanghai, Shanghai, China, 200031
      • Site 15628 - Shanghai Xuhui Center Hospital
    • Shanghai, Shanghai, China, 200040
      • Site 15601 - Huadong Hospital Afflilliated to Fudan University
    • Shanghai, Shanghai, China, 200090
      • Site 15631 - Shanghai Yangpu District Centre Hospital
    • Shanghai, Shanghai, China, 200336
      • Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai, China, 200433
      • Site 15606 - Shanghai Pulmonary Hospital
    • Shanghai, Shanghai, China, 201199
      • Site 15625 - Central Hospital of Shanghai Minhang District
  • Shanxi
    • Taiyuan, Shanxi, China, 0300001
      • Site 15638 - Second Hospital of Shanxi Medical
    • Taiyuan, Shanxi, China, 030001
      • Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Site 15605 - West China Hospital, Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300192
      • Site 15609 - Tianjin First Center Hospital
    • Tianjin, Tianjin, China, 300350
      • Site 15633 - Tianjin Haihe Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Site 15602 - Hangzhou First People's Hospital
    • Taizhou, Zhejiang, China, 317000
      • Site 15642 - Taizhou Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China, 325027
      • Site 15639 -The second Affiliated Hospital of Wenzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF 1535 100/6 µg pMDI; 2 inhalations BID Total Daily Dose = 400/24µg	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)
Active Comparator: Symbicort® Turbohaler®; 2 inhalations BID Total Daily Dose = 640/18µg	Drug: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo; Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (BUD/FF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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)
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)
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
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
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.	At screening visit and week 24

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Professor Fuqiang WEN, M.D., Ph.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Actual): May 6, 2022
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: COPD; Lung functions
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: CCD-01535AC1-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No