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

NCT01917331 | Completed Phase 3 Results DMC

• 2 other identifiers: CCD-1207-PR-00912013-001057-27
• 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 pressurised metered dose inhaler (pMDI) over the equivalent dose of Foster® (beclometasone dipropionate (BDP) / formoterol fumarate (FF), in patients diagnosed with chronic obstructive pulmonary disease (COPD) after 52 weeks of treatment.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

spirometry; severe COPD; lung disease; fixed combination treatment; COPD; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• 1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26

  Changes from baseline in pre-dose morning FEV1 to visit at Week 26. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.

  Baseline (Week 0), Week 26.

• 2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26

  Change from baseline in 2-hour post-dose FEV1, at Week 26. FEV1=Forced expiratory volume in the 1st second. It is the volume of air that can be forced out in one second after taking a deep breath.

  Baseline (Week 0) to 2-hour post-dose at Week 26.

• 3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26

  Transition Dyspnoea Index (TDI) focal score is a symptom-based variable tool, used to assess breathlessness and the impact of intervention. BDI/TDI is a clinical rating method based on a validated tool that measures the impact of dyspnoea based on 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI focal score is the baseline value from which TDI focal score is assessed. BDI scores range from 0 (very severe impairment) to 4 (no impairment) for each domain with the baseline focal score consisting of the sum of each domain (i.e. from 0 to 12). Change from baseline in dyspnoea severity was measured using the TDI. TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain, with the TDI focal score consisting of the sum of each domain (i.e. from -9 to +9). A higher total score indicates improvement, while a lower or negative score indicates worsening symptoms. BDI=Baseline Dyspnoea Index TDI=Transition Dyspnoea Index

  Baseline (Week 0), Week 26.

Secondary Outcomes (16)

• 4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits

  Baseline (Week 0), Week 4. 12, 40, 52.

• 5_Change From Baseline to the Average in Pre-dose Morning FEV1 -- Over the Treatment Period

  Baseline (Week 0), Week 4, 12, 26, 40, 52.

• 6_Number of Participants Defined as Responders Wrt. to FEV1 -- Change From Baseline in Pre-dose Morning FEV1 ≥100 mL -- at Week 26 and Week 52

  Baseline (Week 0), Week 26, Week 52.

• 7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits

  Baseline (Week 0), Week 4, 12, 40, 52.

• 8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits

  Week 4, 12, 26, 40, 52.

Study Arms (2)

Beclometasone/Formoterol/Glycopyrrolate

EXPERIMENTAL

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

Drug: Beclometasone/Formoterol/Glycopyrrolate

Beclometasone/Formoterol

ACTIVE COMPARATOR

Foster® 100/6 µg 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 µg

Beclometasone/Formoterol/Glycopyrrolate

Beclometasone/Formoterol DRUG

Active comparator

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

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 Forced Expiratory Volume in the 1st Second (FEV1) \< 50% of the predicted normal value and a post- bronchodilator FEV1/ Forced Vital Capacity (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

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

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Study Officials

• Dave SINGH, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 21, 2014
• Primary Completion: January 14, 2016
• Study Completion: January 14, 2016
• Last Updated: July 20, 2026
• Results First Posted: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

HU (1)