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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Frequent exacerbators

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)

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.

Day NC, Kumar S, Criner G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kaisermann MC, Kilbride S, Lange P, Lomas DA, Martin N, Martinez FJ, Singh D, Wise R, Lipson DA.

2020-06-0510 citations

10.1186/s12931-020-01398-w

Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials.

Ferguson GT, Brown N, Compton C, Corbridge TC, Dorais K, Fogarty C, Harvey C, Kaisermann MC, Lipson DA, Martin N, Sciurba F, Stiegler M, Zhu CQ, Bernstein D.

2020-05-2930 citations

10.1186/s12931-020-01360-w

<p>Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA</p>

Dave Singh, Leonardo M. Fabbri, Stefano Vezzoli, Stefano Petruzzelli, Alberto Papi

International Journal of COPD2019-02-0121 citations

10.2147/copd.s196383

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.

Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D.

2017-04-03278 citations

10.1016/s0140-6736(17)30188-5

Interventions

DRUGBDP/FF/GB

Superiority over Tiotropium

DRUGTiotropium

Superiority of CHF5993 over Tiotropium

DRUGBDP/FF + Tiotropium

non inferiority vs CHF5993

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
COPD exacerbation rate	52 weeks	Moderate and severe COPD exacerbation rate over 52 weeks of treatment.

Secondary

Measure	Time frame	Description
pre-dose morning FEV1	52 weeks	Change from baseline in pre-dose morning FEV1 at Week 52.

Countries

Germany, Hungary, Italy

Outcome results

None listed