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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911364
• Other study ID #: CCD-1208-PR-0090
• Secondary ID: 2013-000063-91
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3686
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 ß-blockers
• Patients treated with long-acting antihistamines
• Known respiratory disorders other than COPD
• Patients who have clinically significant cardiovascular condition

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BDP/FF/GB
Superiority over Tiotropium
• Tiotropium
Superiority of CHF5993 over Tiotropium
• BDP/FF + Tiotropium
non inferiority vs CHF5993

Locations

Country	Name	City	State
Germany	Institut für klinische Forschung	Hessen
Hungary	Csongrád Megyei Mellkasi Betegségek Szakkórháza	Szeged
Italy	Azienda Ospedaliera Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Germany,  Hungary,  Italy, 

References & Publications (4)

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). pii: 1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May. — View Citation

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. — View Citation

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. Review. — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD exacerbation rate	Moderate and severe COPD exacerbation rate over 52 weeks of treatment.	52 weeks
Secondary	pre-dose morning FEV1	Change from baseline in pre-dose morning FEV1 at Week 52.	52 weeks

External Links

•   CSR Synopsis available in the CHIESI Clinical Study Register
•   Study Record on EU Clinical Trials Register including results