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BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
CHF1535
Formoterol fumarate
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe COPD
  • At least one COPd exacerbation in previous year

Exclusion Criteria:

  • Asthma, allergic rhinitis or other atopic disease
  • Unstable concurrent disease:
  • Evidence of heart failure

Sites / Locations

  • UCL Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BDP/FF

Formoterol fumarate

Arm Description

Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler

Formoterol fumarate 12 µg per metered dose

Outcomes

Primary Outcome Measures

Exacerbation rate Change in pre-dose FEV1

Secondary Outcome Measures

Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication

Full Information

First Posted
June 29, 2009
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00929851
Brief Title
BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)
Official Title
a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
Detailed Description
a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BDP/FF
Arm Type
Experimental
Arm Description
Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler
Arm Title
Formoterol fumarate
Arm Type
Active Comparator
Arm Description
Formoterol fumarate 12 µg per metered dose
Intervention Type
Drug
Intervention Name(s)
CHF1535
Other Intervention Name(s)
Foster, Fostair
Intervention Description
Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose
Intervention Type
Drug
Intervention Name(s)
Formoterol fumarate
Other Intervention Name(s)
Atimos
Intervention Description
Formoterol fumarate 12 µg per metered dose
Primary Outcome Measure Information:
Title
Exacerbation rate Change in pre-dose FEV1
Time Frame
0-4-12-24-36-48 weeks
Secondary Outcome Measure Information:
Title
Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication
Time Frame
0-4-12-24-36-48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe COPD At least one COPd exacerbation in previous year Exclusion Criteria: Asthma, allergic rhinitis or other atopic disease Unstable concurrent disease: Evidence of heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jadwiga A Wedzicha, MD, Prof
Organizational Affiliation
UCL MEDICAL SCHOOL
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL Medical School
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing Access Criteria
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing URL
https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Citations:
PubMed Identifier
29138555
Citation
Singh D, Vezzoli S, Petruzzelli S, Papi A. The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study. Int J Chron Obstruct Pulmon Dis. 2017 Nov 3;12:3263-3271. doi: 10.2147/COPD.S141416. eCollection 2017.
Results Reference
background
PubMed Identifier
30464449
Citation
Siddiqui SH, Pavord ID, Barnes NC, Guasconi A, Lettis S, Pascoe S, Petruzzelli S. Blood eosinophils: a biomarker of COPD exacerbation reduction with inhaled corticosteroids. Int J Chron Obstruct Pulmon Dis. 2018 Nov 6;13:3669-3676. doi: 10.2147/COPD.S179425. eCollection 2018.
Results Reference
background
PubMed Identifier
24953015
Citation
Wedzicha JA, Singh D, Vestbo J, Paggiaro PL, Jones PW, Bonnet-Gonod F, Cohuet G, Corradi M, Vezzoli S, Petruzzelli S, Agusti A; FORWARD Investigators. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. 2014 Aug;108(8):1153-62. doi: 10.1016/j.rmed.2014.05.013. Epub 2014 Jun 6. Erratum In: Respir Med. 2015 Mar;109(3):434-5.
Results Reference
result
PubMed Identifier
22653766
Citation
Singh D, Kampschulte J, Wedzicha JA, Jones PW, Cohuet G, Corradi M, Higenbottam T, Petruzzelli S, Vestbo J. A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations. Eur Respir J. 2013 Jan;41(1):12-7. doi: 10.1183/09031936.00207611. Epub 2012 May 31.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-012546-23
Description
Study Record on EU Clinical Trials Register including results
URL
https://www.chiesi.com/clinic/30_CSR_Synopsis_CCD-0906-PR-0016.pdf
Description
CSR Synopsis available in the CHIESI Clinical Study Register

Learn more about this trial

BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)

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