Chronic Obstructive Pulmonary DiseasePhase 3NCT01911364
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
A Phase 3 study testing BDP/FF/GB, Tiotropium and BDP/FF + Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease) 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?
- BDP/FF/GB, Tiotropium and BDP/FF + Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,686 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2014to Mar 2016
- 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
- Male and female COPD patients aged ≥ 40 years
- Current smokers or ex-smokers
- FEV1<50% predicted (FEV1/FVC <0,7)
- at least 1 documented exacerbations in the last 12 Mo
Who cannot join
- Pregnant or lactating women and all women physiologically capable of becoming pregnant
- Diagnosis of asthma, history of allergic rhinitis or atopy
- Patients treated for exacerbations 1 Mo prior to screening
- Patients treated with non-cardioselective β-blockers
- Patients treated with long-acting antihistamines
- Known respiratory disorders other than COPD
- Patients who have clinically significant cardiovascular condition
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)
Read the detailed description
A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows:
- A pre-screening visit (V0) to obtain the written informed consent from the patient
- A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium
- After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs).
During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily.
AEs/SAEs and COPD exacerbations will be monitored.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BDP/FF/GB, Tiotropium, BDP/FF + Tiotropium
- Keywords
- Frequent exacerbators
- 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.
BDP/FF/GBDrug
Also called CHF 5993 pMDI 100/6/12.5 mcg
Superiority over Tiotropium
TiotropiumDrug
Also called Spiriva 18 mcg 1 capsule o.d
Superiority of CHF5993 over Tiotropium
BDP/FF + TiotropiumDrug
Also called Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d.
non inferiority vs CHF5993
| Study group | Role | What they receive |
|---|---|---|
| BDP/FF/GB | Experimental | CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d Receives: Drug: BDP/FF/GB |
| Tiotropium | Active comparator | Tiotropium bromide 18 mcg Receives: Drug: Tiotropium |
| BDP/FF + Tiotropium | Active comparator | BDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily
BDP/FF/GB versus BDP/FF + Tiotropium Receives: Drug: BDP/FF + Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD exacerbation rate
Moderate and severe COPD exacerbation rate over 52 weeks of treatment.
Measured: 52 weeks
Secondary outcomes (1)
pre-dose morning FEV1
Change from baseline in pre-dose morning FEV1 at Week 52.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
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 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
- 3,686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorgen Vestbo, MD, Principal investigator, Respiratory Research Group, Wythenshawe Hospital, MANCHESTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911364
- Sponsor's protocol ID
- CCD-1208-PR-0090
- Other IDs
- 2013-000063-91
- Status last verified
- Oct 2021
- First submitted
- 26 Jul 2013
- 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
Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, Celli B. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. Int J Chron Obstruct Pulmon Dis. 2018 Dec 12;13:3971-3981. doi: 10.2147/COPD.S185975. eCollection 2018.
PubMed 30587953Singh D, Fabbri LM, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. Int J Chron Obstruct Pulmon Dis. 2019 Feb 28;14:531-546. doi: 10.2147/COPD.S196383. eCollection 2019.
PubMed 30880943Singh D, Fabbri LM, Corradi M, Georges G, Guasconi A, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation. Eur Respir J. 2019 May 18;53(5):1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May.
PubMed 30792343Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919-1929. doi: 10.1016/S0140-6736(17)30188-5. Epub 2017 Apr 3.
PubMed 28385353
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 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01911364
- Acronym / sponsor ID
- CCD-1208-PR-0090
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Frequent exacerbators
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,686 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Jul 2013 (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.
The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)
Detailed description
A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows:
- A pre-screening visit (V0) to obtain the written informed consent from the patient
- A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium
- After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs).
During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily.
AEs/SAEs and COPD exacerbations will be monitored.
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 |
|---|---|---|
| BDP/FF/GB | Experimental | Drug: BDP/FF/GBCHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d |
| Tiotropium | Active comparator | Drug: TiotropiumTiotropium bromide 18 mcg |
| BDP/FF + Tiotropium | Active comparator | Drug: BDP/FF + TiotropiumBDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily BDP/FF/GB versus BDP/FF + Tiotropium |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female COPD patients aged ≥ 40 years
- Current smokers or ex-smokers
- FEV1<50% predicted (FEV1/FVC <0,7)
- at least 1 documented exacerbations in the last 12 Mo
Key exclusion criteria (7 listed)
- Pregnant or lactating women and all women physiologically capable of becoming pregnant
- Diagnosis of asthma, history of allergic rhinitis or atopy
- Patients treated for exacerbations 1 Mo prior to screening
- Patients treated with non-cardioselective β-blockers
- Patients treated with long-acting antihistamines
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 |
|---|---|---|
| BDP/FF/GBAlso: CHF 5993 pMDI 100/6/12.5 mcgSuperiority over Tiotropium | Drug | BDP/FF/GB |
| TiotropiumAlso: Spiriva 18 mcg 1 capsule o.dSuperiority of CHF5993 over Tiotropium | Drug | Tiotropium |
| BDP/FF + TiotropiumAlso: Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d.non inferiority vs CHF5993 | Drug | BDP/FF + Tiotropium |
Primary outcome
COPD exacerbation rate
Time frame: 52 weeks
Moderate and severe COPD exacerbation rate over 52 weeks of treatment.
1 secondary outcome
pre-dose morning FEV1
Time frame: 52 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 30587953Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, Celli B. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. Int J Chron Obstruct Pulmon Dis. 2018 Dec 12;13:3971-3981. doi: 10.2147/COPD.S185975. eCollection 2018.
- Background: PubMed 30880943Singh D, Fabbri LM, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. Int J Chron Obstruct Pulmon Dis. 2019 Feb 28;14:531-546. doi: 10.2147/COPD.S196383. eCollection 2019.
- Background: PubMed 30792343Singh D, Fabbri LM, Corradi M, Georges G, Guasconi A, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation. Eur Respir J. 2019 May 18;53(5):1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May.
- Results publication: PubMed 28385353Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919-1929. doi: 10.1016/S0140-6736(17)30188-5. Epub 2017 Apr 3.
- 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.
Jorgen Vestbo, MD principal investigator
Respiratory Research Group, Wythenshawe Hospital, MANCHESTER
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BDP/FF/GB, Tiotropium and BDP/FF + Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 3 sites in 3 countries.
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 4 inclusion and 7 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 3 sites in Germany, Hungary, Italy. 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?
COPD exacerbation rate (time frame: 52 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 NCT01911364, 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.