BDP/FF Versus Formoterol Fumarate (FF) in Patients With S... | NCT00929851

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

NCT00929851

Sponsor

Chiesi Farmaceutici S.p.A.

Status

Completed

Last Update Posted

Oct 29, 2021Actual

Enrollment

1,199Actual

Phase

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

CHF1535
Formoterol fumarate

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-012546-23	EudraCT Number

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jun 29, 2009

First Submission Date that Met QC Criteria

Jun 29, 2009

First Posted Date

Jun 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2021

Last Update Posted Date

Oct 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,199Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BDP/FF	Experimental	Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler	Drug: CHF1535
Formoterol fumarate	Active Comparator	Formoterol fumarate 12 µg per metered dose	Drug: Formoterol fumarate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHF1535	Drug	Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose	BDP/FF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exacerbation rate Change in pre-dose FEV1		0-4-12-24-36-48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication		0-4-12-24-36-48 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jadwiga A Wedzicha, MD, Prof	UCL MEDICAL SCHOOL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCL Medical School		London			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29138555	Background	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.
30464449	Background

See Also Links

Label	URL
Study Record on EU Clinical Trials Register including results	View source

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

URL

https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005581	Foster Home Care
D000068759	Formoterol Fumarate

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided