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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 3

Locations

Hungary

Study Type

Interventional

Intervention

Beclometasone/Formoterol/Glycopyrrolate

Beclometasone/Formoterol

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring spirometry, severe COPD, lung disease, fixed combination

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dr Beatrix BALINT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Beclometasone/Formoterol/Glycopyrrolate

Beclometasone/Formoterol

Arm Description

CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid

Foster® 100/6 mcg 2 inhalations bid

Outcomes

Primary Outcome Measures

Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at 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

COPD exacerbation rate

Moderate and severe COPD exacerbation rate over 52 weeks of treatment

Full Information

NCT ID

NCT01917331

First Posted

August 5, 2013

Last Updated

October 28, 2021

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT01917331

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

spirometry, severe COPD, lung disease, fixed combination

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1368 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Beclometasone/Formoterol/Glycopyrrolate

Arm Type

Experimental

Arm Description

CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid

Arm Title

Beclometasone/Formoterol

Arm Type

Active Comparator

Arm Description

Foster® 100/6 mcg 2 inhalations bid

Intervention Type

Drug

Intervention Name(s)

Beclometasone/Formoterol/Glycopyrrolate

Other Intervention Name(s)

BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg

Intervention Description

Active drug tested

Intervention Type

Drug

Intervention Name(s)

Beclometasone/Formoterol

Other Intervention Name(s)

Foster® or CHF 1535 pMDI 100/6 mcg

Intervention Description

Active comparator

Primary Outcome Measure Information:

Title

Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26

Description

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

Time Frame

week 26

Secondary Outcome Measure Information:

Title

COPD exacerbation rate

Description

Moderate and severe COPD exacerbation rate over 52 weeks of treatment

Time Frame

week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dave SINGH, MD

Organizational Affiliation

University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr Beatrix BALINT

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30587953

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.

Results Reference

background

PubMed Identifier

30880943

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.

Results Reference

background

PubMed Identifier

30792343

Citation

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.

Results Reference

background

PubMed Identifier

27598678

Citation

Singh D, Papi A, Corradi M, Pavlisova I, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016 Sep 3;388(10048):963-73. doi: 10.1016/S0140-6736(16)31354-X. Epub 2016 Sep 1.

Results Reference

result

Links:

URL

https://www.clinicaltrialsregister.eu/ctr-search/search?query=CCD-1207-PR-0091

Description

EU Clinical Trial Register - Study Record including results

URL

https://www.chiesi.com/clinic/CSR_Synopsis_CCD-1207-PR-0091.pdf

Description

CSR Synopsis available in the CHIESI Clinical Study Register

Learn more about this trial

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

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