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

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

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Source Chiesi Farmaceutici S.p.A.
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.

Overall Status Recruiting
Start Date July 30, 2018
Completion Date April 2021
Primary Completion Date April 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Demonstration of the non-inferiority of CHF 1535 pMDI versus Symbicort® Turbohaler® in terms of pulmonary function At week 24
Secondary Outcome
Measure Time Frame
Effect of CHF 1535 on change from baseline pre-dose morning FEV1 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) 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 At week 12, week 24
Effect of CHF 1535 on change from baseline in COPD Assessment Test (CAT) Over 28 weeks
Effect of CHF 1535 on the rate of COPD exacerbations Over 24 weeks of treatment
Number of patients with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Over 29 weeks (from Visit 0 to Visit 6)
Assessment of blood pressure Over 28 weeks (from Visit 1 to Visit 6)
Number of subjects with abnormal Electrocardiogram (ECG) findings At screening visit and week 24
Number of subjects with abnormal Haematology parameters At screening visit and week 24
Number of subjects with abnormal Blood Chemistry parameters At screening visit and week 24
Enrollment 750
Condition
Intervention

Intervention type: Drug

Intervention name: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo

Description: Fixed combination of beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg (BDP/FF)

Arm group label: CHF 1535 100/6 µg pMDI

Intervention type: Drug

Intervention name: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo

Description: Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (BUD/FF)

Arm group label: Symbicort® Turbohaler®

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

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Professor Fuqiang WEN, M.D., Ph.D. Principal Investigator West China Hospital
Overall Contact

Last name: Chiesi Clinical Trial Info

Phone: +39 0521 279 715

Email: [email protected]

Location
facility status
Site 15604 - Anhui Provincial Hospital | Hefei, Anhui, 230001, China Recruiting
Site 15635 - The Second Hospital of Anhui Medical Hospital | Hefei, Anhui, 231200, China Not yet recruiting
Site 15613 - Beijing Friendship Hospital, Capital Medical University | Beijing, Beijing, 100050, China Recruiting
Site 15611 - Xuanwu Hospital Capital Medical University | Beijing, Beijing, 100053, China Recruiting
Site 15640 - Peking University Shougang Hospital | Beijing, Beijing, 100144, China Recruiting
Site 15626 - Peking University Third Hospital | Beijing, Beijing, 100191, China Recruiting
Site 15612 - Beijing Tong Ren Hospital, Capital Medical University | Beijing, Beijing, 100730, China Recruiting
Site 15634 - Chongqing General Hospital | Chongqing, Chongqing, 400013, China Recruiting
Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District | Chongqing, Chongqing, 400020, China Recruiting
Site 15636 - Fujian Province Hospital | Fuzhou, Fujian, 350001, China Not yet recruiting
Site 15650 - The First Hospital of Lanzhou University | Lanzhou, Gansu, 730000, China Recruiting
Site 15630 - Dongguan People's Hospital | Dongguan, Guangdong, 523059, China Active, not recruiting
Site 15607 - The First People's Hospital of Shunde | Foshan, Guangdong, 528300, China Recruiting
Site 15619 - The Third Affiliated Hospital of Southern Medical University | Guangzhou, Guangdong, 510000, China Recruiting
Site 15608 - The First Affiliated Hospital Sun Yat-sen University | Guangzhou, Guangdong, 510030, China Not yet recruiting
Site 15646 - The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou, Guangdong, 510260, China Recruiting
Site 15651 - The Second Xiangya Hospital of Central South University | Guangzhou, Guangdong, 510260, China Not yet recruiting
Site 15614 - Guangzhou Panyu central hospital | Guangzhou, Guangdong, 511400, China Recruiting
Site 15618 - Affiliated Hospital of Guangdong Medical University | Zhanjiang, Guangdong, 524000, China Recruiting
Site 15637 - Affiliated Hospital of Zunyi Medical College | Zunyi, Guizhou, 563099, China Recruiting
Site 15623 - Haikou People's Hospital | Haikou, Hainan, 570208, China Recruiting
Site 15645 - Hainan General Hospital | Haikou, Hainan, 570311, China Recruiting
Site 15617 - Henan Provincial Chest Hospital | Zhengzhou, Henan, 450008, China Recruiting
Site 15622 - The Third Hospital of Changsha | Changsha, Hunan, 410015, China Recruiting
Site 15647 - The Second hospital. University of South China | Hengyang, Hunan, 421001, China Recruiting
Site 15653 - Xiangtan Central Hospital | Xiangtan, Hunan, 411100, China Recruiting
Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University | Hohhot, Inner Mongolia, 010050, China Recruiting
Site 15627 - Nanjing Medical University Affiliated 2nd Hospital | Nanjing, Jiangsu, 210011, China Not yet recruiting
Site 15621 - Wuxi People's Hospital | Wuxi, Jiangsu, 241023, China Recruiting
Site 15632 - Xuzhou Central Hospital | Xuzhou, Jiangsu, 221009, China Recruiting
Site 15643 - No.2 Hospital Affiliated to Jilin University | Changchun, Jilin, 130041, China Recruiting
Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University | Dalian, Liaoning, 116033, China Recruiting
Site 15644 - Jinan Central Hospital | Jinan, Shandong, 250013, China Recruiting
Site 15629 - Shanghai East Hospital | Shanghai, Shanghai, 2000120, China Recruiting
Site 15628 - Shanghai Xuhui Center Hospital | Shanghai, Shanghai, 200031, China Recruiting
Site 15601 - Huadong Hospital Afflilliated to Fudan University | Shanghai, Shanghai, 200040, China Recruiting
Site 15631 - Shanghai Yangpu District Centre Hospital | Shanghai, Shanghai, 200090, China Terminated
Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine | Shanghai, Shanghai, 200336, China Recruiting
Site 15606 - Shanghai Pulmonary Hospital | Shanghai, Shanghai, 200433, China Recruiting
Site 15625 - Central Hospital of Shanghai Minhang District | Shanghai, Shanghai, 201199, China Recruiting
Site 15638 - Second Hospital of Shanxi Medical | Taiyuan, Shanxi, 0300001, China Active, not recruiting
Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University | Taiyuan, Shanxi, 030001, China Recruiting
Site 15605 - West China Hospital, Sichuan University | Chengdu, Sichuan, 610041, China Recruiting
Site 15609 - Tianjin First Center Hospital | Tianjin, Tianjin, 300192, China Recruiting
Site 15633 - Tianjin Haihe Hospital | Tianjin, Tianjin, 300350, China Recruiting
Site 15602 - Hangzhou First People's Hospital | Hangzhou, Zhejiang, 310006, China Recruiting
Site 15642 - Taizhou Hospital of Zhejiang Province | Taizhou, Zhejiang, 317000, China Recruiting
Site 15639 -The second Affiliated Hospital of Wenzhou Medical College | Wenzhou, Zhejiang, 325027, China Recruiting
Location Countries

China

Verification Date

March 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CHF 1535 100/6 µg pMDI

Arm group type: Experimental

Description: 2 inhalations BID Total Daily Dose = 400/24µg

Arm group label: Symbicort® Turbohaler®

Arm group type: Active Comparator

Description: 2 inhalations BID Total Daily Dose = 640/18µg

Acronym FORSYYN
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov