Chronic Obstructive Pulmonary DiseasePhase 2TRI-DNCT03590379
Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing CHF 5993 DPI, CHF5993 pMDI and CHF 1535 pMDI in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
Trial summary
The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- CHF 5993 DPI, CHF5993 pMDI and CHF 1535 pMDI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 1 siteBulgaria
- Study dates
- 15 Jun 2018to 6 Mar 2019
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of COPD;
- Current smokers or ex-smokers;
- A Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) < 0.7;
- Patients' COPD therapy (stable regimen at least 30 days before screening) with either:
- Inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
- Inhaled corticosteroids/long-acting β2-agonist (free or fixed) combination
- Inhaled long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
- Inhaled long-acting muscarinic antagonist alone.
Who cannot join
- Pregnant and lactating women;
- Diagnosis of asthma;
- Known respiratory disorders other than COPD;
- Patients treated for a moderate or severe COPD exacerbation within 6 weeks prior to screening or during the run-in period;
- Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
- Patients who have clinically significant cardiovascular condition;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multicentre, Randomised, Double-blind, Double-dummy, Active-controlled, 3-way Cross-over Study to Evaluate the Efficacy of CHF 5993 Administered Via Dry Powder Inhaler (DPI) Versus CHF 5993 Via Pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- CHF 5993 DPI, CHF5993 pMDI, CHF 1535 pMDI, Placebo DPI, Placebo pMDI
- 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.
CHF 5993 DPIDrug
BDP/FF/GB DPI
CHF5993 pMDIDrug
BDP/FF/GB pMDI
CHF 1535 pMDIDrug
BDP/FF pMDI
Placebo DPIDrug
CHF 5993 DPI matched placebo
Placebo pMDIDrug
CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)
| Study group | Role | What they receive |
|---|---|---|
| CHF 5993 DPI | Experimental | BDP/FF/GB DPI 100/6/12,5 mcg Receives: Drug: CHF 5993 DPI; Drug: Placebo pMDI |
| CHF 5993 pMDI | Active comparator | BDP/FF/GB pMDI 100/6/12,5 mcg Receives: Drug: CHF5993 pMDI; Drug: Placebo DPI |
| CHF 1535 pMDI | Active comparator | BDP/FF pMDI 100/6 mcg Receives: Drug: CHF 1535 pMDI; Drug: Placebo DPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 AUC0-12h (Area Under the Curve for Forced Expiratory Volume in 1 second measured serially for 0-12 hours) normalised by time (L) on dosing Day 28
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of FEV1 AUC0-12h normalized by time, in COPD patients
Measured: Day 28
Trough FEV1 at 24 hours (L) on dosing Day 28.
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of trough FEV1 at 24h on dosing Day 28 in COPD patients
Measured: Day 28
Secondary outcomes (3)
Change from baseline in pre-dose morning FEV1 (L) on Day 28
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Measured: from Baseline to Day 28
Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Measured: from Baseline to Day 28
Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1
To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Measured: from Baseline to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start15 Jun 2018
- Primary completion16 Oct 2018
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kai-Michael Beeh, MD, Principal investigator, Institut fuer Atemwegsforschung GmbH, Wiesbaden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590379
- Sponsor's protocol ID
- CLI-05993BA1-02
- Other IDs
- 2017-004405-41, 2017
- Acronym
- TRI-D
- Status last verified
- Apr 2021
- First submitted
- 6 Jun 2018
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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.
Publications
Beeh KM, Kuna P, Corradi M, Viaud I, Guasconi A, Georges G. Comparison of Dry-Powder Inhaler and Pressurized Metered-Dose Inhaler Formulations of Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Patients with COPD: The TRI-D Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2021 Jan 14;16:79-89. doi: 10.2147/COPD.S291030. eCollection 2021.
PubMed 33488071
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicentre, Randomised, Double-blind, Double-dummy, Active-controlled, 3-way Cross-over Study to Evaluate the Efficacy of CHF 5993 Administered Via Dry Powder Inhaler (DPI) Versus CHF 5993 Via Pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03590379
- Acronym / sponsor ID
- TRI-D / CLI-05993BA1-02
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- 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 evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF 5993 DPI | Experimental | Drug: CHF 5993 DPI, Drug: Placebo pMDIBDP/FF/GB DPI 100/6/12,5 mcg |
| CHF 5993 pMDI | Active comparator | Drug: CHF5993 pMDI, Drug: Placebo DPIBDP/FF/GB pMDI 100/6/12,5 mcg |
| CHF 1535 pMDI | Active comparator | Drug: CHF 1535 pMDI, Drug: Placebo DPIBDP/FF pMDI 100/6 mcg |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of COPD;
- Current smokers or ex-smokers;
- A Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) < 0.7;
- Patients' COPD therapy (stable regimen at least 30 days before screening) with either:
Key exclusion criteria (6 listed)
- Pregnant and lactating women;
- Diagnosis of asthma;
- Known respiratory disorders other than COPD;
- Patients treated for a moderate or severe COPD exacerbation within 6 weeks prior to screening or during the run-in period;
- Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
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 |
|---|---|---|
| CHF 5993 DPIBDP/FF/GB DPI | Drug | CHF 5993 DPI |
| CHF5993 pMDIBDP/FF/GB pMDI | Drug | CHF 5993 pMDI |
| CHF 1535 pMDIBDP/FF pMDI | Drug | CHF 1535 pMDI |
| Placebo DPICHF 5993 DPI matched placebo | Drug | CHF 1535 pMDI, CHF 5993 pMDI |
| Placebo pMDICHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs) | Drug | CHF 5993 DPI |
Primary outcome
FEV1 AUC0-12h (Area Under the Curve for Forced Expiratory Volume in 1 second measured serially for 0-12 hours) normalised by time (L) on dosing Day 28
Time frame: Day 28
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of FEV1 AUC0-12h normalized by time, in COPD patients
Trough FEV1 at 24 hours (L) on dosing Day 28.
Time frame: Day 28
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of trough FEV1 at 24h on dosing Day 28 in COPD patients
3 secondary outcomes
Change from baseline in pre-dose morning FEV1 (L) on Day 28
Time frame: from Baseline to Day 28
Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28
Time frame: from Baseline to Day 28
Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1
Time frame: from Baseline to Day 1
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 12 Apr 2021.
- Results publication: PubMed 33488071Beeh KM, Kuna P, Corradi M, Viaud I, Guasconi A, Georges G. Comparison of Dry-Powder Inhaler and Pressurized Metered-Dose Inhaler Formulations of Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Patients with COPD: The TRI-D Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2021 Jan 14;16:79-89. doi: 10.2147/COPD.S291030. eCollection 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.
Kai-Michael Beeh, MD principal investigator
Institut fuer Atemwegsforschung GmbH, Wiesbaden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF 5993 DPI, CHF5993 pMDI and CHF 1535 pMDI in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Bulgaria.
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 8 inclusion and 6 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 12 Apr 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 Bulgaria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
FEV1 AUC0-12h (Area Under the Curve for Forced Expiratory Volume in 1 second measured serially for 0-12 hours) normalised by time (L) on dosing Day 28 (time frame: Day 28). The study lists 2 primary outcomes in all. 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 NCT03590379, which also lists 1 linked publication.
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 12 Apr 2021.