Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT01911364|
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : July 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: BDP/FF/GB Drug: Tiotropium Drug: BDP/FF + Tiotropium||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3686 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d
Superiority over Tiotropium
Other Name: CHF 5993 pMDI 100/6/12.5 mcg
Active Comparator: Tiotropium
Tiotropium bromide 18 mcg
Superiority of CHF5993 over Tiotropium
Other Name: Spiriva 18 mcg 1 capsule o.d
Active Comparator: 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
Drug: BDP/FF + Tiotropium
non inferiority vs CHF5993
Other Name: Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d.
- COPD exacerbation rate [ Time Frame: 52 weeks ]Moderate and severe COPD exacerbation rate over 52 weeks of treatment.
- pre-dose morning FEV1 [ Time Frame: 52 weeks ]Change from baseline in pre-dose morning FEV1 at Week 52.
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): NCT01911364
|Institut für klinische Forschung|
|Csongrád Megyei Mellkasi Betegségek Szakkórháza|
|Azienda Ospedaliera Perugia|
|Principal Investigator:||Jorgen Vestbo, MD||Respiratory Research Group, Wythenshawe Hospital, MANCHESTER|