Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01917331 |
Recruitment Status :
Completed
First Posted : August 6, 2013
Last Update Posted : October 29, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Drug: Beclometasone/Formoterol/Glycopyrrolate Drug: Beclometasone/Formoterol | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1368 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | March 2014 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Beclometasone/Formoterol/Glycopyrrolate
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid
|
Drug: Beclometasone/Formoterol/Glycopyrrolate
Active drug tested
Other Name: BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg |
Active Comparator: Beclometasone/Formoterol
Foster® 100/6 mcg 2 inhalations bid
|
Drug: Beclometasone/Formoterol
Active comparator
Other Name: Foster® or CHF 1535 pMDI 100/6 mcg |
- Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26 [ Time Frame: 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
- COPD exacerbation rate [ Time Frame: week 52 ]Moderate and severe COPD exacerbation rate over 52 weeks of treatment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917331
Hungary | |
Dr Beatrix BALINT | |
Szeged, Hungary, 6722 |
Principal Investigator: | Dave SINGH, MD | University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK |
Publications of Results:
Other Publications:
Responsible Party: | Chiesi Farmaceutici S.p.A. |
ClinicalTrials.gov Identifier: | NCT01917331 |
Other Study ID Numbers: |
CCD-1207-PR-0091 |
First Posted: | August 6, 2013 Key Record Dates |
Last Update Posted: | October 29, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
spirometry severe COPD lung disease fixed combination |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Beclomethasone Glycopyrrolate Formoterol Fumarate Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Adrenergic beta-2 Receptor Agonists |
Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |