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Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

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ClinicalTrials.gov Identifier: NCT01917331
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Study Description
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Brief Summary:
Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Beclometasone/Formoterol/Glycopyrrolate Drug: Beclometasone/Formoterol Phase 3

Detailed Description:

This 52-week randomised 2 parallel groups study aimed at evaluating the superiority of fixed triple therapy with ICS/LABA/LAMA compared to ICS/LABA in severe to very severe COPD patients.

Patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead ECG, vital signs measurement. This visit was followed by a 2-week open-label run-in period under Foster® (BDP/FF 400/24 µg total daily dose). Eligible patients were then randomised to either fixed triple therapy BDP/FF/GB or BDP/FF. During the 52-week treatment period, completing patients did have 5 subsequent visits post randomisation scheduled respectively after 4 (Visit 3), 12 (Visit 4), 26 (Visit 5), 40 (Visit 6) and 52 (Visit 7) weeks of treatment.

During these, pre-dose and post-dose spirometry, 12-lead ECG, vital signs, dyspnea assessments were performed. Rescue medication use, compliance with the treatment and EXACT-PRO questionnaire were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone+Formoterol+Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : March 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Beclometasone/Formoterol/Glycopyrrolate
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid
 Drug: Beclometasone/Formoterol/Glycopyrrolate
Active drug tested
Other Name: BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg
Active Comparator: Beclometasone/Formoterol
Foster® 100/6 mcg 2 inhalations bid
 Drug: Beclometasone/Formoterol
Active comparator
Other Name: Foster® or CHF 1535 pMDI 100/6 mcg


Outcome Measures
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Primary Outcome Measures :
  1. Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26 [ Time Frame: week 26 ]
    • Change from baseline in pre-dose morning FEV1 at Week 26.
    • Change from baseline to the 2-hour post-dose value of FEV1 at Week 26.
    • TDI focal score at Week 26


Secondary Outcome Measures :
  1. COPD exacerbation rate [ Time Frame: week 52 ]
    Moderate and severe COPD exacerbation rate over 52 weeks of treatment


Eligibility Criteria
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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 < 0.7
  • At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of asthma or history of allergic rhinitis or atopy
  • Patients treated with non-cardioselective β-blockers in the month preceding the screening visit
  • Patients treated for exacerbations in the 4 weeks prior to 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 PRN
  • 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
Contacts and Locations
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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): NCT01917331


Locations
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Hungary
Dr Beatrix BALINT
Szeged, Hungary, 6722
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Dave SINGH, MD University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01917331    
Other Study ID Numbers: CCD-1207-PR-0091
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chiesi Farmaceutici S.p.A.:
spirometry
severe COPD
lung disease
fixed combination
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Beclomethasone
Glycopyrrolate
Formoterol Fumarate
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
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists