Phase 3
N=1,368
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
Chronic Obstructive Pulmonary Disease (COPD)
Bottom Line
View on ClinicalTrials.gov: NCT01917331 ↗Enrolled (actual)
1,368
Serious AEs
16.8%
Results posted
Jun 2026
Primary outcome: Primary: 1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26 — 0.082; 0.001 litre — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Beclometasone/Formoterol/Glycopyrrolate (Drug); Beclometasone/Formoterol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26 |
0.082; 0.001 | < 0.001 sig |
| PRIMARY 2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26 |
0.261; 0.145 | < 0.001 sig |
| PRIMARY 3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26 |
1.71; 1.50 | = 0.160 |
| SECONDARY 4_Change From Baseline in Pre-dose Morning FEV1 -- at All the Other Clinic Visits |
0.093; 0.022; 0.078; 0.010; 0.095; 0.018 | < 0.001 sig |
| SECONDARY 5_Change From Baseline to the Average in Pre-dose Morning FEV1 -- Over the Treatment Period |
0.084; 0.012 | < 0.001 sig |
| SECONDARY 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 |
287; 165; 259; 158 | < 0.001 sig |
| SECONDARY 7_Change From Baseline in 2-hour Post-dose of FEV1 -- at All the Other Clinic Visits |
0.215; 0.138; 0.268; 0.153; 0.261; 0.146 | < 0.001 sig |
| SECONDARY 8_Change From Pre-dose to 2-hour Post-dose FEV1 -- at All Study Visits |
0.177; 0.130; 0.183; 0.138; 0.180; 0.149 | < 0.001 sig |
| SECONDARY 9_Transition Dyspnoea Index (TDI) Focal Score -- at All Study Visits |
1.54; 1.12; 1.77; 1.39; 1.80; 1.65 | = 0.002 sig |
| SECONDARY 10_Number of Participants With Transition Dyspnoea Index (TDI) Response (Focal Score ≥1) -- at Week 26 and Week 52 |
394; 352; 370; 354 | = 0.027 sig |
| SECONDARY 11a_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Total Score |
-3.66; -2.19; -4.70; -2.66; -4.76; -3.43 | = 0.007 sig |
| SECONDARY 11b_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Symptoms Score |
-5.02; -3.83; -5.09; -4.56; -6.80; -5.17 | = 0.126 |
| SECONDARY 11c_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Impacts Score |
-3.44; -2.29; -4.65; -2.72; -4.88; -3.50 | = 0.077 |
| SECONDARY 11d_Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) -- at All Study Visits: Activity Score |
-2.69; -1.21; -3.93; -1.35; -3.88; -2.17 | = 0.034 sig |
| SECONDARY 12_Number of Participants With Saint George's Respiratory Questionnaire (SGRQ) Response (Change From Baseline in Total Score ≤-4) -- at Week 26 and Week 52 |
321; 246; 297; 244 | < 0.001 sig |
| SECONDARY 13a_Change From Baseline for Percentage of Days Without Intake of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment) |
6.67; 2.46; 6.23; 3.18; 5.49; 2.40 | = 0.001 sig |
| SECONDARY 13b_Change From Baseline for the Average Use of Rescue Medication -- Over Entire Treatment Period (52 Weeks of Treatment) |
-0.29; -0.07; -0.25; -0.06; -0.21; -0.02 | = 0.001 sig |
| SECONDARY 14_Rate of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Rate -- Over Entire Treatment Period (52 Weeks of Treatment) |
0.410; 0.530 | = 0.005 sig |
| SECONDARY 15_First Occurrence of All Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
214; 240 | 0.02 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
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
Data sourced from ClinicalTrials.gov (NCT01917331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.