Pulmonary Disease, Chronic ObstructivePhase 3NCT00929851
BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)
A Phase 3 study testing CHF1535 and Formoterol fumarate in people with Pulmonary Disease, Chronic Obstructive, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- CHF1535 and Formoterol fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,199 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe COPD
- At least one COPd exacerbation in previous year
Who cannot join
- Asthma, allergic rhinitis or other atopic disease
- Unstable concurrent disease:
- Evidence of heart failure
Trial locations and contacts
1 site in 1 country.
About this study
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
a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
Read the 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
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- CHF1535, Formoterol fumarate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF1535Drug
Also called Foster, Fostair
Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose
Formoterol fumarateDrug
Also called Atimos
Formoterol fumarate 12 µg per metered dose
| Study group | Role | What they receive |
|---|---|---|
| BDP/FF | Experimental | Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler Receives: Drug: CHF1535 |
| Formoterol fumarate | Active comparator | Formoterol fumarate 12 µg per metered dose Receives: Drug: Formoterol fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation rate Change in pre-dose FEV1
Measured: 0-4-12-24-36-48 weeks
Secondary outcomes (1)
Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication
Measured: 0-4-12-24-36-48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jadwiga A Wedzicha, MD, Prof, Principal investigator, UCL MEDICAL SCHOOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929851
- Sponsor's protocol ID
- CCD-0906-PR-0016
- Other IDs
- 2009-012546-23, 2009
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2009
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29138555Siddiqui 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.
PubMed 30464449Wedzicha 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.
PubMed 24953015Singh 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.
PubMed 22653766
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00929851
- Acronym / sponsor ID
- CCD-0906-PR-0016
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,199 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BDP/FF | Experimental | Drug: CHF1535Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler |
| Formoterol fumarate | Active comparator | Drug: Formoterol fumarateFormoterol fumarate 12 µg per metered dose |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Severe COPD
- At least one COPd exacerbation in previous year
Key exclusion criteria (3 listed)
- Asthma, allergic rhinitis or other atopic disease
- Unstable concurrent disease:
- Evidence of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF1535Also: Foster, FostairBeclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose | Drug | BDP/FF |
| Formoterol fumarateAlso: AtimosFormoterol fumarate 12 µg per metered dose | Drug | Formoterol fumarate |
Primary outcome
Exacerbation rate Change in pre-dose FEV1
Time frame: 0-4-12-24-36-48 weeks
1 secondary outcome
Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication
Time frame: 0-4-12-24-36-48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 29138555Singh 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.
- Background: PubMed 30464449Siddiqui 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 publication: PubMed 24953015Wedzicha 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.
- Results publication: PubMed 22653766Singh 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.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jadwiga A Wedzicha, MD, Prof principal investigator
UCL MEDICAL SCHOOL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHF1535 and Formoterol fumarate in people with Pulmonary Disease, Chronic Obstructive, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation rate Change in pre-dose FEV1 (time frame: 0-4-12-24-36-48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929851, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.