Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
NCT ID: NCT01911364
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3686 participants
INTERVENTIONAL
2014-01-31
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BDP/FF/GB
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d
BDP/FF/GB
Superiority over Tiotropium
Tiotropium
Tiotropium bromide 18 mcg
Tiotropium
Superiority of CHF5993 over Tiotropium
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
BDP/FF + Tiotropium
non inferiority vs CHF5993
Interventions
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BDP/FF/GB
Superiority over Tiotropium
Tiotropium
Superiority of CHF5993 over Tiotropium
BDP/FF + Tiotropium
non inferiority vs CHF5993
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current smokers or ex-smokers
* FEV1\<50% predicted (FEV1/FVC \<0,7)
* at least 1 documented exacerbations in the last 12 Mo
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Jorgen Vestbo, MD
Role: PRINCIPAL_INVESTIGATOR
Respiratory Research Group, Wythenshawe Hospital, MANCHESTER
Locations
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Institut für klinische Forschung
Hessen, , Germany
Csongrád Megyei Mellkasi Betegségek Szakkórháza
Szeged, , Hungary
Azienda Ospedaliera Perugia
Perugia, , Italy
Countries
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References
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Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, Celli B. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. Int J Chron Obstruct Pulmon Dis. 2018 Dec 12;13:3971-3981. doi: 10.2147/COPD.S185975. eCollection 2018.
Singh D, Fabbri LM, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. Int J Chron Obstruct Pulmon Dis. 2019 Feb 28;14:531-546. doi: 10.2147/COPD.S196383. eCollection 2019.
Singh D, Fabbri LM, Corradi M, Georges G, Guasconi A, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation. Eur Respir J. 2019 May 18;53(5):1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May.
Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919-1929. doi: 10.1016/S0140-6736(17)30188-5. Epub 2017 Apr 3.
Related Links
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Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
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2013-000063-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-1208-PR-0090
Identifier Type: -
Identifier Source: org_study_id