Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo
- Registration Number
- NCT03888131
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHF 1535 100/6 µg pMDI CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo 2 inhalations BID Total Daily Dose = 400/24µg Symbicort® Turbohaler® Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo 2 inhalations BID Total Daily Dose = 640/18µg
- Primary Outcome Measures
Name Time Method Demonstration of the non-inferiority of CHF 1535 pMDI versus Symbicort® Turbohaler® in terms of pulmonary function At week 24 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
Name Time Method Effect of CHF 1535 on change from baseline pre-dose morning FEV1 At week 4, week 12, week 18 and week 24 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) At week 4, week 12, week 18 and week 24 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 At week 12, week 24 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 the rate of COPD exacerbations Over 24 weeks of treatment 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 deathNumber of subjects with abnormal Electrocardiogram (ECG) findings At screening visit and week 24 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 At screening visit and week 24 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).
Effect of CHF 1535 on change from baseline in COPD Assessment Test (CAT) Over 28 weeks 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.
Assessment of blood pressure Over 28 weeks (from Visit 1 to Visit 6) Systolic and diastolic blood pressure will be measured at all clinical visits from Visit 1 after 10 minutes in seated resting position.
Number of patients with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Over 29 weeks (from Visit 0 to Visit 6) 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.Number of subjects with abnormal Blood Chemistry parameters At screening visit and week 24 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.
Related Research Topics
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Trial Locations
- Locations (53)
Site 15633 - Tianjin Haihe Hospital
🇨🇳Tianjin, Tianjin, China
Site 15642 - Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Site 15639 -The second Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, Zhejiang, China
Site 15602 - Hangzhou First People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Site 15604 - Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Site 15645 - Hainan General Hospital
🇨🇳Haikou, Hainan, China
Site 15635 - The Second Hospital of Anhui Medical Hospital
🇨🇳Hefei, Anhui, China
Site 15626 - Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Site 15611 - Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Site 15613 - Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Site 15640 - Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
🇨🇳Chongqing, Chongqing, China
Site 15636 - Fujian Province Hospital
🇨🇳Fuzhou, Fujian, China
Site 15634 - Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
Site 15630 - Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Site 15650 - The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Site 15607 - The First People's Hospital of Shunde
🇨🇳Foshan, Guangdong, China
Site 15608 - The First Affiliated Hospital Sun Yat-sen University
🇨🇳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 15614 - Guangzhou Panyu central hospital
🇨🇳Guangzhou, Guangdong, China
Site 15656 - The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Site 15637 - Affiliated Hospital of Zunyi Medical College
🇨🇳Zunyi, Guizhou, China
Site 15618 - Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
Site 15623 - Haikou People's Hospital
🇨🇳Haikou, Hainan, China
Site 15622 - The Third Hospital of Changsha
🇨🇳Changsha, Hunan, China
Site 15654 - Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Site 15617 - Henan Provincial Chest Hospital
🇨🇳Zhengzhou, Henan, China
Site 15647 - The Second hospital. University of South China
🇨🇳Hengyang, Hunan, China
Site 15653 - Xiangtan Central Hospital
🇨🇳Xiangtan, Hunan, China
Site 15603 - The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Site 15621 - Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Site 15627 - Nanjing Medical University Affiliated 2nd Hospital
🇨🇳Nanjing, Jiangsu, China
Site 15657 - Zhong Da Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
Site 15644 - Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Site 15659 - Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
Site 15632 - Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Site 15643 - No.2 Hospital Affiliated to Jilin University
🇨🇳Changchun, Jilin, China
Site 15658 - Jilin Province People's Hospital
🇨🇳Changchun, Jilin, China
Site 15629 - Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Site 15628 - Shanghai Xuhui Center Hospital
🇨🇳Shanghai, Shanghai, China
Site 15648 - Dalian Municipal Central Hospital Affiliated of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Site 15601 - Huadong Hospital Afflilliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Site 15631 - Shanghai Yangpu District Centre Hospital
🇨🇳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 15638 - Second Hospital of Shanxi Medical
🇨🇳Taiyuan, Shanxi, China
Site 15605 - West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Site 15649 - The 1st Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Site 15609 - Tianjin First Center Hospital
🇨🇳Tianjin, Tianjin, China