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Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01917331
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE August 5, 2013
First Posted Date  ICMJE August 6, 2013
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01917331 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2013)
COPD exacerbation rate [ Time Frame: week 52 ]
Moderate and severe COPD exacerbation rate over 52 weeks of treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
Official Title  ICMJE 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
Brief Summary Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Beclometasone/Formoterol/Glycopyrrolate
    Active drug tested
    Other Name: BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg
  • Drug: Beclometasone/Formoterol
    Active comparator
    Other Name: Foster® or CHF 1535 pMDI 100/6 mcg
Study Arms  ICMJE
  • Experimental: Beclometasone/Formoterol/Glycopyrrolate
    CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid
    Intervention: Drug: Beclometasone/Formoterol/Glycopyrrolate
  • Active Comparator: Beclometasone/Formoterol
    Foster® 100/6 mcg 2 inhalations bid
    Intervention: Drug: Beclometasone/Formoterol
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2013)
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female adults aged ≥ 40 years with a diagnosis of COPD
  • Current smokers or ex-smokers
  • A post-bronchodilator FEV1 < 50% of the predicted normal value and a post- bronchodilator FEV1/FVC < 0.7
  • At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of asthma or history of allergic rhinitis or atopy
  • Patients treated with non-cardioselective β-blockers in the month preceding the screening visit
  • Patients treated for exacerbations in the 4 weeks prior to screening visit
  • Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
  • Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
  • Known respiratory disorders other than COPD
  • Patients who have clinically significant cardiovascular condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01917331
Other Study ID Numbers  ICMJE CCD-1207-PR-0091
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dave SINGH, MD University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP