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.
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Trial Locations
- Locations (53)
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, China
Site 15611 - Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Site 15640 - Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
Site 15626 - Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Site 15612 - Beijing Tong Ren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Site 15634 - Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
Site 15616 - Chongqing Red Cross Hospital, People's Hospital of Jiangbei District
🇨🇳Chongqing, Chongqing, China
Site 15636 - Fujian Province Hospital
🇨🇳Fuzhou, Fujian, China
Scroll for more (43 remaining)Site 15604 - Anhui Provincial Hospital🇨🇳Hefei, Anhui, China