Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)
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|ClinicalTrials.gov Identifier: NCT03888131|
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo Drug: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||July 30, 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
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)
- Demonstration of the non-inferiority of CHF 1535 pMDI versus Symbicort® Turbohaler® in terms of pulmonary function [ Time Frame: 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)
- Effect of CHF 1535 on change from baseline pre-dose morning FEV1 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 change from baseline in COPD Assessment Test (CAT) [ Time Frame: 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.
- Effect of CHF 1535 on the rate of COPD exacerbations [ Time Frame: 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 death
- Number of patients with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.
- Assessment of blood pressure [ Time Frame: 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 subjects with abnormal Electrocardiogram (ECG) findings [ Time Frame: 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 [ Time Frame: 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).
- Number of subjects with abnormal Blood Chemistry parameters [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888131
|Contact: Chiesi Clinical Trial Info||+39 0521 279 email@example.com|
|Contact: Fuqiang WENfirstname.lastname@example.org|
Show 48 Study Locations
|Principal Investigator:||Professor Fuqiang WEN, M.D., Ph.D.||West China Hospital|