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Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01911364
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: BDP/FF/GB Drug: Tiotropium Drug: BDP/FF + Tiotropium Phase 3

Detailed Description:

A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows:

  • A pre-screening visit (V0) to obtain the written informed consent from the patient
  • A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium
  • After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs).

During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily.

AEs/SAEs and COPD exacerbations will be monitored.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3686 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: BDP/FF/GB
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d
Drug: BDP/FF/GB
Superiority over Tiotropium
Other Name: CHF 5993 pMDI 100/6/12.5 mcg

Active Comparator: Tiotropium
Tiotropium bromide 18 mcg
Drug: Tiotropium
Superiority of CHF5993 over Tiotropium
Other Name: Spiriva 18 mcg 1 capsule o.d

Active Comparator: BDP/FF + Tiotropium

BDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily

BDP/FF/GB versus BDP/FF + Tiotropium

Drug: BDP/FF + Tiotropium
non inferiority vs CHF5993
Other Name: Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d.




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


Secondary Outcome Measures :
  1. pre-dose morning FEV1 [ Time Frame: 52 weeks ]
    Change from baseline in pre-dose morning FEV1 at Week 52.



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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 and female COPD patients aged ≥ 40 years
  • Current smokers or ex-smokers
  • FEV1<50% predicted (FEV1/FVC <0,7)
  • at least 1 documented exacerbations in the last 12 Mo

Exclusion Criteria:

  • Pregnant or lactating women and all women physiologically capable of becoming pregnant
  • Diagnosis of asthma, history of allergic rhinitis or atopy
  • Patients treated for exacerbations 1 Mo prior to screening
  • Patients treated with non-cardioselective β-blockers
  • Patients treated with long-acting antihistamines
  • 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): NCT01911364


Locations
Germany
Institut für klinische Forschung
Hessen, Germany
Hungary
Csongrád Megyei Mellkasi Betegségek Szakkórháza
Szeged, Hungary
Italy
Azienda Ospedaliera Perugia
Perugia, Italy
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Jorgen Vestbo, MD Respiratory Research Group, Wythenshawe Hospital, MANCHESTER

Additional Information:
Publications of Results:
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01911364     History of Changes
Other Study ID Numbers: CCD-1208-PR-0090
2013-000063-91 ( EudraCT Number )
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chiesi Farmaceutici S.p.A.:
Frequent exacerbators

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Tiotropium Bromide
Beclomethasone
Glycopyrrolate
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
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Adjuvants, Anesthesia
Muscarinic Antagonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists