A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 3,686
- Locations
- 3
- Primary Endpoint
- COPD exacerbation rate
Study Overview
Brief Summary
The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)
Detailed Description
A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows:
- A pre-screening visit (V0) to obtain the written informed consent from the patient
- A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium
- After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs).
During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily.
AEs/SAEs and COPD exacerbations will be monitored.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female COPD patients aged ≥ 40 years
- •Current smokers or ex-smokers
- •FEV1<50% predicted (FEV1/FVC <0,7)
- •at least 1 documented exacerbations in the last 12 Mo
Exclusion Criteria
- •Pregnant or lactating women and all women physiologically capable of becoming pregnant
- •Diagnosis of asthma, history of allergic rhinitis or atopy
- •Patients treated for exacerbations 1 Mo prior to screening
- •Patients treated with non-cardioselective β-blockers
- •Patients treated with long-acting antihistamines
- •Known respiratory disorders other than COPD
- •Patients who have clinically significant cardiovascular condition
Arms & Interventions
BDP/FF/GB
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d
Intervention: BDP/FF/GB (Drug)
Tiotropium
Tiotropium bromide 18 mcg
Intervention: Tiotropium (Drug)
BDP/FF + Tiotropium
BDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily
BDP/FF/GB versus BDP/FF + Tiotropium
Intervention: BDP/FF + Tiotropium (Drug)
Outcomes
Primary Outcomes
COPD exacerbation rate
Time Frame: 52 weeks
Moderate and severe COPD exacerbation rate over 52 weeks of treatment.
Secondary Outcomes
- pre-dose morning FEV1(52 weeks)