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Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)

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ClinicalTrials.gov Identifier: NCT03197818
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.

Condition or disease Intervention/treatment Phase
COPD (Chronic Obstructive Pulmonary Disease) Drug: CHF 5993 100/6/12.5 µg Drug: 160 µg budesonide + 4.5 µg formoterol fumarate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI (CHF 5993) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbuhaler®) in Patients With Chronic Obstructive Pulmonary Disease
Actual Study Start Date : December 13, 2016
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: CHF 5993 100/6/12.5 µg
Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide)
Drug: CHF 5993 100/6/12.5 µg
Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose

Active Comparator: Symbicort Turbuhaler 160/4.5 µg
Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)
Drug: 160 µg budesonide + 4.5 µg formoterol fumarate
Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg




Primary Outcome Measures :
  1. Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24 [ Time Frame: Baseline to Week 24 ]
    Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24

  2. Change from Baseline in 2-hour post-dose FEV1 at week 24 [ Time Frame: Baseline to Week 24 ]
    Change from Baseline in 2-hour post-dose FEV1 at week 24


Secondary Outcome Measures :
  1. Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24 [ Time Frame: Baseline to Week 24 ]
    Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose

  2. Time to First COPD exacerbation [ Time Frame: Baseline to week 24 ]
    Time to First COPD exacerbation

  3. Rate of COPD exacerbations [ Time Frame: Baseline to week 24 ]
    Rate of COPD exacerbations

  4. Change in COPD Assessment Test (CAT) [ Time Frame: At all visits (from baseline to Week 24) ]
    Change in COPD Assessment Test (CAT)


Other Outcome Measures:
  1. Adverse Events and Adverse Drug reactions [ Time Frame: Screening up to week 24 ]
    Adverse Events and Adverse Drug reactions



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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:

  • Male or Female adults aged > 40 years with a diagnosis of COPD
  • Current smokers or ex-smokers
  • A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI
  • At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of asthma, history of allergic rhinitis or atopy
  • Patients treated for exacerbations in the 4 weeks prior to screening visit
  • Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit
  • Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata
  • Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia
  • Known respiratory disorders other than COPD
  • Patients who have clinically significant cardiovascular condition

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): NCT03197818


Contacts
Contact: Chiesi Clinical Trial Info clinicaltrials_info@chiesi.com

  Show 55 Study Locations
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Jinping Zheng The First Affiliated Hospital of Guangzhou Medical University

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT03197818     History of Changes
Other Study ID Numbers: CCD-5993AA1-14
China ( Other Identifier: China: Food and Drug Administration )
Taiwan ( Other Identifier: Taiwan : Food and Drug Administration )
South Korea ( Other Identifier: Ministry of Food and Drugs Safety )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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.:
COPD
Anticholinergics
Triple Combination

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Beclomethasone
Glycopyrrolate
Bromides
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
Anticonvulsants
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists