Status:
COMPLETED
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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 (chroni...
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 GLYCOPYRROLAT...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
3686 Patients enrolled
Trial Details
Trial ID
NCT01911364
Start Date
January 1 2014
End Date
March 1 2016
Last Update
October 29 2021
Active Locations (3)
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1
Institut für klinische Forschung
Hessen, Germany
2
Csongrád Megyei Mellkasi Betegségek Szakkórháza
Szeged, Hungary
3
Azienda Ospedaliera Perugia
Perugia, Italy