Chronic Obstructive Pulmonary DiseasePhase 3NCT00476099
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
A Phase 3 study testing Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI and Formoterol 12 µg DPI in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in France.
Trial summary
To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI and Formoterol 12 µg DPI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 828 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2006to Nov 2008
- 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
- Clinical diagnosis of COPD (according to GOLD guidelines)
- FEV1 > or equal 30% and < 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
- COPD symptoms for at least 2 years
- At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
- Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year
Who cannot join
- Current or past diagnosis of asthma, or any evidence suggestive of asthma
- Positive FEV1 reversibility test
- Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
- Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
- Long term oxygen therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)
To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.
Read the detailed description
The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI, Formoterol 12 µg DPI
- 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.
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDIDrug
Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
Budesonide 200 µg plus formoterol 6 µg DPIDrug
two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
Formoterol 12 µg DPIDrug
one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
| Study group | Role | What they receive |
|---|---|---|
| Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI | Experimental | Not described Receives: Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI; Drug: Budesonide 200 µg plus formoterol 6 µg DPI; Drug: Formoterol 12 µg DPI |
| Budesonide 200 µg plus formoterol 6 µg DPI | Active comparator | Not described Receives: Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI; Drug: Budesonide 200 µg plus formoterol 6 µg DPI; Drug: Formoterol 12 µg DPI |
| Formoterol 12 µg DPI | Active comparator | Not described Receives: Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI; Drug: Budesonide 200 µg plus formoterol 6 µg DPI; Drug: Formoterol 12 µg DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of COPD exacerbations and pre-dose morning FEV1
Measured: one year treatment
Secondary outcomes (3)
Other pulmonary function parameters,
Measured: one year treatment
COPD symptom scores and Quality of Life,
Measured: one year treatment
safety and tolerability
Measured: one year treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startDec 2006
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 828 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter M.A. Calverley, Professor, Principal investigator, Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476099
- Sponsor's protocol ID
- DM/PR/033011/005/05
- Other IDs
- 2006-002489-20
- Status last verified
- Oct 2021
- First submitted
- 18 May 2007
- 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, Corradi M, Spinola M, Petruzzelli S, Papi A. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2016 Jun 16;26:16030. doi: 10.1038/npjpcrm.2016.30.
PubMed 27309985Calverley PM, Kuna P, Monso E, Costantini M, Petruzzelli S, Sergio F, Varoli G, Papi A, Brusasco V. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. Epub 2010 Oct 20.
PubMed 20965712
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, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00476099
- Acronym / sponsor ID
- DM/PR/033011/005/05
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 828 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 May 2007 (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.
To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.
Detailed description
The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI | Experimental | Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Drug: Budesonide 200 µg plus formoterol 6 µg DPI, Drug: Formoterol 12 µg DPI |
| Budesonide 200 µg plus formoterol 6 µg DPI | Active comparator | Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Drug: Budesonide 200 µg plus formoterol 6 µg DPI, Drug: Formoterol 12 µg DPI |
| Formoterol 12 µg DPI | Active comparator | Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Drug: Budesonide 200 µg plus formoterol 6 µg DPI, Drug: Formoterol 12 µg DPI |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of COPD (according to GOLD guidelines)
- FEV1 > or equal 30% and < 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
- COPD symptoms for at least 2 years
- At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
- Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year
Key exclusion criteria (5 listed)
- Current or past diagnosis of asthma, or any evidence suggestive of asthma
- Positive FEV1 reversibility test
- Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
- Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
- Long term oxygen therapy
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 |
|---|---|---|
| Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDIBeclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m. | Drug | Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI, Formoterol 12 µg DPI |
| Budesonide 200 µg plus formoterol 6 µg DPItwo oral inhalations twice a day at 8.00 a.m. and 8.00 p.m. | Drug | Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI, Formoterol 12 µg DPI |
| Formoterol 12 µg DPIone oral inhalation twice a day at 8.00 a.m. and 8.00 p.m. | Drug | Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI, Formoterol 12 µg DPI |
Primary outcome
Number of COPD exacerbations and pre-dose morning FEV1
Time frame: one year treatment
3 secondary outcomes
Other pulmonary function parameters,
Time frame: one year treatment
COPD symptom scores and Quality of Life,
Time frame: one year treatment
safety and tolerability
Time frame: one year treatment
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 27309985Singh D, Corradi M, Spinola M, Petruzzelli S, Papi A. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2016 Jun 16;26:16030. doi: 10.1038/npjpcrm.2016.30.
- Results publication: PubMed 20965712Calverley PM, Kuna P, Monso E, Costantini M, Petruzzelli S, Sergio F, Varoli G, Papi A, Brusasco V. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. Epub 2010 Oct 20.
- 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.
Peter M.A. Calverley, Professor principal investigator
Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom
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 Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI and Formoterol 12 µg DPI in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in France.
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 5 inclusion and 5 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 France. 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?
Number of COPD exacerbations and pre-dose morning FEV1 (time frame: one year treatment). 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 NCT00476099, which also lists 2 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.