Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01911364
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3686
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BDP/FF/GB BDP/FF/GB CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d BDP/FF + Tiotropium 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 Tiotropium Tiotropium Tiotropium bromide 18 mcg
- Primary Outcome Measures
Name Time Method COPD exacerbation rate 52 weeks Moderate and severe COPD exacerbation rate over 52 weeks of treatment.
- Secondary Outcome Measures
Name Time Method pre-dose morning FEV1 52 weeks Change from baseline in pre-dose morning FEV1 at Week 52.
Trial Locations
- Locations (3)
Azienda Ospedaliera Perugia
🇮🇹Perugia, Italy
Institut für klinische Forschung
🇩🇪Hessen, Germany
Csongrád Megyei Mellkasi Betegségek Szakkórháza
🇭🇺Szeged, Hungary