NCT00929851

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,199

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

June 29, 2009

Last Update Submit

October 28, 2021

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Exacerbation rate Change in pre-dose FEV1

    0-4-12-24-36-48 weeks

Secondary Outcomes (1)

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

    0-4-12-24-36-48 weeks

Study Arms (2)

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

CHF1535DRUG

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

Also known as: Foster, Fostair
BDP/FF
Formoterol fumarateDRUG

Formoterol fumarate 12 µg per metered dose

Also known as: Atimos
Formoterol fumarate

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL Medical School

London, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 29138555BACKGROUND

  • 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.

    PMID: 30464449BACKGROUND

  • 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.

    PMID: 24953015RESULT

  • 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.

    PMID: 22653766RESULT

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Foster Home CareFormoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Jadwiga A Wedzicha, MD, Prof

    UCL MEDICAL SCHOOL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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.

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

Locations

GB(1)