Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient
NCT ID: NCT03888131
Last Updated: 2024-11-25
Study Results
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Basic Information
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COMPLETED
PHASE3
750 participants
INTERVENTIONAL
2018-07-30
2022-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CHF 1535 100/6 µg pMDI
2 inhalations BID Total Daily Dose = 400/24µg
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®
2 inhalations BID Total Daily Dose = 640/18µg
Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo
Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (BUD/FF)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* COPD exacerbation requiring OCS/antibiotics or hospitalization during the run-in period
* Known respiratory disorders other than COPD
* Diagnosis of asthma
40 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Professor Fuqiang WEN, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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Site 15604 - Anhui Provincial Hospital
Hefei, Anhui, China
Site 15635 - The Second Hospital of Anhui Medical Hospital
Hefei, Anhui, China
Site 15613 - Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Site 15611 - Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Site 15640 - Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Site 15626 - Peking University Third Hospital
Beijing, Beijing Municipality, China
Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Site 15634 - Chongqing General Hospital
Chongqing, Chongqing Municipality, China
Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
Chongqing, Chongqing Municipality, China
Site 15636 - Fujian Province Hospital
Fuzhou, Fujian, China
Site 15650 - The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Site 15630 - Dongguan People's Hospital
Dongguan, Guangdong, China
Site 15607 - The First People's Hospital of Shunde
Foshan, Guangdong, China
Site 15619 - The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Site 15608 - The First Affiliated Hospital Sun Yat-sen 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 15614 - Guangzhou Panyu central hospital
Guangzhou, Guangdong, China
Site 15618 - Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang, China
Site 15637 - Affiliated Hospital of Zunyi Medical College
Zunyi, Guizhou, China
Site 15623 - Haikou People's Hospital
Haikou, Hainan, China
Site 15645 - Hainan General Hospital
Haikou, Hainan, China
Site 15654 - Henan Provincial People's Hospital
Zhengzhou, Henan, China
Site 15617 - Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Site 15622 - The Third Hospital of Changsha
Changsha, Hu'nan, China
Site 15647 - The Second hospital. University of South China
Hengyang, Hu'nan, China
Site 15653 - Xiangtan Central Hospital
Xiangtan, Hu'nan, China
Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Site 15657 - Zhong Da Hospital, Southeast University
Nanjing, Jiangsu, China
Site 15627 - Nanjing Medical University Affiliated 2nd Hospital
Nanjing, Jiangsu, China
Site 15621 - Wuxi People's Hospital
Wuxi, Jiangsu, China
Site 15632 - Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Site 15659 - Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Site 15658 - Jilin Province People's Hospital
Changchun, Jilin, China
Site 15643 - No.2 Hospital Affiliated to Jilin University
Changchun, Jilin, China
Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, China
Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University
Taiyuan, Shan'xi, China
Site 15644 - Jinan Central Hospital
Jinan, Shandong, China
Site 15629 - Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Site 15628 - Shanghai Xuhui Center Hospital
Shanghai, Shanghai Municipality, China
Site 15601 - Huadong Hospital Afflilliated to Fudan University
Shanghai, Shanghai Municipality, China
Site 15631 - Shanghai Yangpu District Centre Hospital
Shanghai, Shanghai Municipality, China
Site 15610 - Tong Ren Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Site 15606 - Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Site 15625 - Central Hospital of Shanghai Minhang District
Shanghai, Shanghai Municipality, China
Site 15638 - Second Hospital of Shanxi Medical
Taiyuan, Shanxi, China
Site 15605 - West China Hospital, Sichuan University
Chengdu, Sichuan, China
Site 15609 - Tianjin First Center Hospital
Tianjin, Tianjin Municipality, China
Site 15633 - Tianjin Haihe Hospital
Tianjin, Tianjin Municipality, China
Site 15602 - Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Site 15642 - Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Site 15639 -The second Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Countries
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References
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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.
Other Identifiers
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CCD-01535AC1-02
Identifier Type: -
Identifier Source: org_study_id
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