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

NCT01917331 | Completed Phase 3 DMC

• 1 other identifier: CCD-1207-PR-0091
• Study Type: interventional
• Target: 1,368
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

spirometry; severe COPD; lung disease; fixed combination

Outcome Measures

Primary Outcomes (1)

• 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

  week 26

Secondary Outcomes (1)

• COPD exacerbation rate

  week 52

Study Arms (2)

Beclometasone/Formoterol/Glycopyrrolate

EXPERIMENTAL

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

Drug: Beclometasone/Formoterol/Glycopyrrolate

Beclometasone/Formoterol

ACTIVE COMPARATOR

Foster® 100/6 mcg 2 inhalations bid

Drug: Beclometasone/Formoterol

Interventions

Beclometasone/Formoterol/Glycopyrrolate DRUG

Active drug tested

Also known as: BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg

Beclometasone/Formoterol/Glycopyrrolate

Beclometasone/Formoterol DRUG

Active comparator

Also known as: Foster® or CHF 1535 pMDI 100/6 mcg

Beclometasone/Formoterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

Dr Beatrix BALINT

Szeged, 6722, Hungary

Location

Related Publications (4)

• 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.

  PMID: 30587953 BACKGROUND

• 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.

  PMID: 30880943 BACKGROUND

• 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.

  PMID: 30792343 BACKGROUND

• 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.

  PMID: 27598678 RESULT

Related Links

• EU Clinical Trial Register - Study Record including results
• CSR Synopsis available in the CHIESI Clinical Study Register

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Beclomethasone; Formoterol Fumarate; Foster Home Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dave SINGH, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 6, 2013
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)