Chronic Obstructive Pulmonary DiseasePhase 3NCT02467452
Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing BDP/FF/GB and FlF/VI + Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Hungary.
Trial summary
The purpose of the study is to demonstrate the triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality of life in 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 and FlF/VI + Tiotropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,479 participants
- Where
- 1 siteHungary
- Study dates
- May 2015to Jan 2017
- 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 adults aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
- Patients with a diagnosis of COPD at least 12 months before the screening visit (according to GOLD document updated 2014).
- Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20].
- A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) < 0.7 at least 10-15 min after 4 puffs (4 x 100 μg) of salbutamol pMDI. If this criterion is not met at screening, the test can be repeated once before randomisation.
- A documented history of at least one exacerbation in the 12 months preceding the screening visit.
- COPD exacerbation will be defined according to the following:
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- "A sustained worsening of the patient's condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics or need for hospitalization". Also documented visits to an emergency department due to COPD exacerbation are considered acceptable to fulfil this criterion.
- Patients under double therapy for at least 2 months prior to screening visit with either:
- inhaled corticosteroids/long-acting β2-agonist combination (fixed or free), without regular use of short-acting muscarinic antagonist (regular use means 2 puffs 4 times per day at least) or
- inhaled corticosteroids/long-acting muscarinic antagonist free combination, without regular use of short-acting β2-agonist (regular use means 2 puffs 4 times per day at least) or
- Inhaled long-acting β2-agonist and inhaled long-acting muscarinic antagonist or
- Patients under monotherapy with long-acting muscarinic antagonist for at least 2 months prior to screening.
- Symptomatic patients at screening with a CAT score ≥10.
- A cooperative attitude and ability to use correctly the inhalers.
- A cooperative attitude and ability to use correctly the daily electronic Diary (eDiary).
Who cannot join
- Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more methods of contraception as defined in the protocol
- Patients with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy
- Patients requiring use of the following medications:
- A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening
- A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening
- phosphodiesterase-4 (PDE4) inhibitors in the 4 weeks prior to screening
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- Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening
- COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period
- Patients treated with non-cardio selective β-blockers in the month preceding the screening visit or during the run-in period. Those patients may enter the study after non-selective β-blockers withdrawal and/or cardio selective β-blockers intake for at least 10 days before randomization
- Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as o re nata (PRN).
- Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
- Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator's judgment
- Patients who have clinically significant cardiovascular condition
- Patients with atrial fibrillation (AF):
- Paroxysmal Atrial Fibrillation
- Persistent: AF episode either lasts longer than 7 days or requires termination by cardioversion, either with drugs or by direct current cardioversion (DCC) within 6 months from screening
- Long standing Persistent as defined by continuous atrial fibrillation diagnosed for less than 6 months with or without a rhythm control strategy
- Permanent: for at least 6 months with a resting ventricular rate ≥ 100/min controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy)
- An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator's judgement Patients whose electrocardiogram (ECG12 lead) shows QT Interval Corrected by the Fridericia Correction Formula (QTcF) >450 ms for males or QTcF >470 ms for females at screening visit are not eligible (not applicable for patient with pacemaker)
- Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents
- History of hypersensitivity to anticholinergics, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement
- Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement
- Patients with hypokalaemia (serum potassium levels <3.5 milliequivalent per liter (mEq/L) (or 3.5 mmol/L)) or uncontrolled hyperkalaemia according to investigator's judgment
- Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the efficacy or the safety of the study drug according to investigator's judgment.
- Patients with any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next six months (after V1) or with malignancy for which they are currently undergoing radiation therapy or chemotherapy
- History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit
- Participation in another clinical trial where investigation drug was received less than 8 weeks prior to screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multinational, Multicentre, Randomised, Open-Label, Active-Controlled, 26-Week, 2-Arm, Parallel Group Study to Evaluate the Non-Inferiority of Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) Administered Via Pressurized Metered-dose Inhaler (pMDI) Versus Fixed Combination Of Fluticasone Furoate Plus Vilanterol Administered Via Dry Powder Inhaler (DPI) (Relvar®) Plus Tiotropium Bromide (Spiriva®) for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
The purpose of the study is to demonstrate the triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality of life in COPD patients (Chronic Obstructive Pulmonary Disease).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- BDP/FF/GB, FlF/VI + Tiotropium
- 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
FlF/VI + TiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| BDP/FF/GB | Experimental | Drug: BDP/FF/GB Other name: CHF 5993 pMDI 100/6/12 mcg Receives: Drug: BDP/FF/GB |
| FlF/VI + Tiotropium | Active comparator | FlF/VI + Tiotropium Other name: Relvar DPI 100/25 mcg + Spiriva 18 mcg capsule Receives: Drug: FlF/VI + Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Saint George's Respiratory Questionnaire (SGRQ) total score at Week 26.
the primary efficacy variable is the numeric value of the change
Measured: 26 weeks
Secondary outcomes (2)
SGRQ response (change from baseline in total score ≤ -4) at Week 26.
the secondary efficacy variable is derived as a categorisation of this value
Measured: 26 weeks
rced expiratory volume at one second (FEV1) response (change from baseline in pre-dose morning FEV1 ≥ 100 ml) at Week 26.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 1,479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467452
- Sponsor's protocol ID
- CCD-05993AA1-07
- Other IDs
- 2014-001487-35, 2014
- Status last verified
- Oct 2021
- First submitted
- 20 May 2015
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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.
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 Multinational, Multicentre, Randomised, Open-Label, Active-Controlled, 26-Week, 2-Arm, Parallel Group Study to Evaluate the Non-Inferiority of Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) Administered Via Pressurized Metered-dose Inhaler (pMDI) Versus Fixed Combination Of Fluticasone Furoate Plus Vilanterol Administered Via Dry Powder Inhaler (DPI) (Relvar®) Plus Tiotropium Bromide (Spiriva®) for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02467452
- Acronym / sponsor ID
- CCD-05993AA1-07
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,479 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Jun 2015 (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 the study is to demonstrate the triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality of life in COPD patients (Chronic Obstructive Pulmonary Disease).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BDP/FF/GB | Experimental | Drug: BDP/FF/GBDrug: BDP/FF/GB Other name: CHF 5993 pMDI 100/6/12 mcg |
| FlF/VI + Tiotropium | Active comparator | Drug: FlF/VI + TiotropiumFlF/VI + Tiotropium Other name: Relvar DPI 100/25 mcg + Spiriva 18 mcg capsule |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male and female adults aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
- Patients with a diagnosis of COPD at least 12 months before the screening visit (according to GOLD document updated 2014).
- Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20].
- A post-bronchodilator FEV1 < 50% of the predicted normal value and a post-bronchodilator forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) < 0.7 at least 10-15 min after 4 puffs (4 x 100 μg) of salbutamol pMDI. If this criterion is not met at screening, the test can be repeated once before randomisation.
- A documented history of at least one exacerbation in the 12 months preceding the screening visit.
Key exclusion criteria (27 listed)
- Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more methods of contraception as defined in the protocol
- Patients with a current clinical diagnosis of asthma with a physician-judged need for inhaled or oral corticosteroid therapy
- Patients requiring use of the following medications:
- COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period
- Patients treated with non-cardio selective β-blockers in the month preceding the screening visit or during the run-in period. Those patients may enter the study after non-selective β-blockers withdrawal and/or cardio selective β-blockers intake for at least 10 days before randomization
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/GB | Drug | BDP/FF/GB |
| FlF/VI + Tiotropium | Drug | FlF/VI + Tiotropium |
Primary outcome
Change from baseline in the Saint George's Respiratory Questionnaire (SGRQ) total score at Week 26.
Time frame: 26 weeks
the primary efficacy variable is the numeric value of the change
2 secondary outcomes
SGRQ response (change from baseline in total score ≤ -4) at Week 26.
Time frame: 26 weeks
rced expiratory volume at one second (FEV1) response (change from baseline in pre-dose morning FEV1 ≥ 100 ml) at Week 26.
Time frame: 26 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 BDP/FF/GB and FlF/VI + Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Hungary.
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 15 inclusion and 27 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 Hungary. 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?
Change from baseline in the Saint George's Respiratory Questionnaire (SGRQ) total score at Week 26. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.