Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
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|ClinicalTrials.gov Identifier: NCT01917331|
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Beclometasone/Formoterol/Glycopyrrolate Drug: Beclometasone/Formoterol||Phase 3|
This 52-week randomised 2 parallel groups study aimed at evaluating the superiority of fixed triple therapy with ICS/LABA/LAMA compared to ICS/LABA in severe to very severe COPD patients.
Patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead ECG, vital signs measurement. This visit was followed by a 2-week open-label run-in period under Foster® (BDP/FF 400/24 µg total daily dose). Eligible patients were then randomised to either fixed triple therapy BDP/FF/GB or BDP/FF. During the 52-week treatment period, completing patients did have 5 subsequent visits post randomisation scheduled respectively after 4 (Visit 3), 12 (Visit 4), 26 (Visit 5), 40 (Visit 6) and 52 (Visit 7) weeks of treatment.
During these, pre-dose and post-dose spirometry, 12-lead ECG, vital signs, dyspnea assessments were performed. Rescue medication use, compliance with the treatment and EXACT-PRO questionnaire were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1368 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone+Formoterol+Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid
Active drug tested
Other Name: BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg
Active Comparator: Beclometasone/Formoterol
Foster® 100/6 mcg 2 inhalations bid
Other Name: Foster® or CHF 1535 pMDI 100/6 mcg
- Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26 [ Time Frame: week 26 ]
- Change from baseline in pre-dose morning FEV1 at Week 26.
- Change from baseline to the 2-hour post-dose value of FEV1 at Week 26.
- TDI focal score at Week 26
- COPD exacerbation rate [ Time Frame: week 52 ]Moderate and severe COPD exacerbation rate over 52 weeks of treatment
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): NCT01917331
|Dr Beatrix BALINT|
|Szeged, Hungary, 6722|
|Principal Investigator:||Dave SINGH, MD||University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK|