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Trial record 26 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

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
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.


  7. 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.

  8. 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.

  9. 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).

  10. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Chiesi Clinical Trial Info +39 0521 279 715 clinicaltrials_info@chiesi.com
Contact: Fuqiang WEN +8602885422380 wenfuqiang@126.com

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Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Professor Fuqiang WEN, M.D., Ph.D. West China Hospital

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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT03888131     History of Changes
Other Study ID Numbers: CCD-01535AC1-02
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chiesi Farmaceutici S.p.A.:
Lung functions
COPD

Additional relevant MeSH terms:
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Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Beclomethasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists