Chronic Obstructive Pulmonary DiseasePhase 4TRIFORCENCT05097014
CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD
A Phase 4 study testing CHF5993 and CHF1535 in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Germany.
Trial summary
Double Blind, Multinational, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535)… 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?
- CHF5993 and CHF1535
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 28 Oct 2021to 24 Feb 2023
- Phase
- Phase 4
- 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
- A signed and dated written informed consent obtained prior to any study-related procedures.
- Outpatient population.
- Male or female subjects.
- COPD diagnosis for at least 12 months before the Screening visit in accordance with the definition by the GOLD 2020 report.
- Current or ex-smokers (who quit smoking for 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]. E-cigarettes smoking cannot be used to calculate pack-year history.
- A post-bronchodilator FEV1/FVC < 0.7 within 30 min after 4 puffs (4 x 100 µg) of salbutamol pMDI and a post-bronchodilator FEV1 ≥ 40% and <80% of the predicted normal values. If this is not met at screening, the test can be repeated once before randomisation.
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- Pre-bronchodilator functional residual capacity (FRC) of > 120% of predicted normal FRC values at Screening visit 1. If this criterion is not met at screening, the test can be repeated once before randomisation.
- A score of >2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1.
- Subjects on mono- or dual inhaled maintenance COPD treatment at a stable dose for at least 3 months prior to screening.
- A cooperative attitude and ability to correctly use the study inhalers.
- Female subjects must be women either of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) or physiologically capable of becoming pregnant (i.e. women of childbearing potential (WOCBP)).
- CWRCE at Visit 1b: between 2 min and 11 min at 80% of maximum workload. In case the subject cycles for a shorter (i.e. < 2 min) or longer (i.e. > 11 min) period, the visit can be repeated with an adjusted workload once within a 1-week period.
- Oxygen saturation (SpO2 measured by pulse oximeter) at least 82% during the incremental exercise test (IET) performed in the run-in period.
- Subjects must be able to complete CWRCE at Visit 1b and then at Visit 2 without requirement for supplemental oxygen.
Who cannot join
- Pregnant or lactating women.
- Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator's judgment. This can include but is not limited to current diagnosis of asthma, alfa-1 antitrypsin deficiency, active tuberculosis, lung cancer, severe bronchiectasis unrelated to COPD, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
- Unstable concurrent disease: e.g. fever, uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled cardiac disease, 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.
- Moderate (requiring prescriptions of systemic corticosteroids and/or antibiotics) or severe (leading to hospitalization) COPD exacerbation in the 3 and 12 months, respectively, prior to Screening visit 1 and during the run-in period.
- 8. Subjects requiring long term (> 15 hours a day) oxygen therapy for chronic hypoxemia.
- 5. Subjects who have clinically severe cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, myocardial infarction in the prior 6 months, not controlled arrhythmia etc.), which may impact the efficacy or the safety of the study drug according to the investigator's judgement.
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- 6. An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to investigator's judgement. Subjects whose 12-lead ECG shows QTcF >450 ms for males or QTcF >470 ms for females at screening visit are not eligible.
- 7. History of hypersensitivity to M3 receptor antagonists, 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.
- 8. Subjects with serum potassium levels ≤ 3.5 mEq/L (or 3.5 mmol/L) 9. Subjects with body mass index less than 15 or greater than 35 kg/m2. 10. History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
- 11. Subjects with contraindications to cardiopulmonary exercise testing, including those whose exercise test is limited by non-respiratory or cardiovascular condition, e.g. by neurologic, orthopaedic, or other disorders.
- 12. Participation in another clinical trial where investigational drug was received less than 30 days or 5 half-lives whichever is longer prior to screening visit.
Trial locations and contacts
1 site in 1 country.
Germany1 site
PAREXEL International GmbH Early Phase Clinical Unit Berlin
Berlin-Spandau, Berlin Spandauer Damm, 130 D-14050
About this study
Official title: A Double Blind, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Double Blind, Multinational, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- CHF5993, CHF1535, Matched placebo
- Keywords
- Lung hyperinflation, exercise endurance time
- 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.
CHF5993Drug
Also called TRIMBOW®
Pressurized metered dose inhaler (pMDI) 2 inhalations bid
CHF1535Drug
Also called FOSTER®
Pressurized metered dose inhaler (pMDI) 2 inhalations bid
Matched placeboOther
Pressurized metered dose inhaler (pMDI) 2 inhalations bid
| Study group | Role | What they receive |
|---|---|---|
| CHF5993 | Active comparator | pMDI fixed combination product of beclometasone dipropionate (BDP) 100 µg plus 6 µg of formoterol fumarate (FF) and 10 µg of glycopyrronium (G) Receives: Drug: CHF5993 |
| CHF1535 | Active comparator | pMDI fixed combination product beclometasone dipropionate (BDP) 100 µg plus 6 µg of formoterol fumarate (FF) Receives: Drug: CHF1535 |
| Matched placebo | Placebo comparator | Matched placebo pMDI Receives: Other: Matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory capacity (IC) prior to Constant Work Rate Cycle Ergometry (CWRCE) test
Change from baseline in 2-hour post-dose
Measured: 3 weeks of treatment
Secondary outcomes (2)
IC at Isotime, defined as the shortest CWRCE test duration among baseline and end of treatment period.
Change from baseline
Measured: 3 weeks of treatment
Exercise endurance time (EET)
Change from baseline in 2-hour post-dose
Measured: 3 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start28 Oct 2021
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Watz, MD, Study director, Pulmonary Research Institute at LungenClinic Grosshansdorf, German Center for Lung Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097014
- Sponsor's protocol ID
- CLI-05993AA1-17
- Other IDs
- 2020-004718-36
- Acronym
- TRIFORCE
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2021
- Last updated
- 24 Mar 2023
- 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
Watz H, Kirsten AM, Ludwig-Sengpiel A, Krull M, Mroz RM, Georges G, Varoli G, Charretier R, Cortellini M, Vele A, Galkin D. Effects of inhaled beclometasone dipropionate/formoterol fumarate/glycopyrronium vs. beclometasone dipropionate/formoterol fumarate and placebo on lung hyperinflation and exercise endurance in chronic obstructive pulmonary disease: a randomised controlled trial. Respir Res. 2024 Oct 17;25(1):378. doi: 10.1186/s12931-024-02993-x.
PubMed 39420338
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT05097014
- Acronym / sponsor ID
- TRIFORCE / CLI-05993AA1-17
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung hyperinflation, exercise endurance time
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 27 Oct 2021 (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.
Double Blind, Multinational, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (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 |
|---|---|---|
| CHF5993 | Active comparator | Drug: CHF5993pMDI fixed combination product of beclometasone dipropionate (BDP) 100 µg plus 6 µg of formoterol fumarate (FF) and 10 µg of glycopyrronium (G) |
| CHF1535 | Active comparator | Drug: CHF1535pMDI fixed combination product beclometasone dipropionate (BDP) 100 µg plus 6 µg of formoterol fumarate (FF) |
| Matched placebo | Placebo comparator | Other: Matched placeboMatched placebo pMDI |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A signed and dated written informed consent obtained prior to any study-related procedures.
- Outpatient population.
- Male or female subjects.
- COPD diagnosis for at least 12 months before the Screening visit in accordance with the definition by the GOLD 2020 report.
- Current or ex-smokers (who quit smoking for 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]. E-cigarettes smoking cannot be used to calculate pack-year history.
Key exclusion criteria (11 listed)
- Pregnant or lactating women.
- Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator's judgment. This can include but is not limited to current diagnosis of asthma, alfa-1 antitrypsin deficiency, active tuberculosis, lung cancer, severe bronchiectasis unrelated to COPD, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
- Unstable concurrent disease: e.g. fever, uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled cardiac disease, 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.
- Moderate (requiring prescriptions of systemic corticosteroids and/or antibiotics) or severe (leading to hospitalization) COPD exacerbation in the 3 and 12 months, respectively, prior to Screening visit 1 and during the run-in period.
- 8. Subjects requiring long term (> 15 hours a day) 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 |
|---|---|---|
| CHF5993Also: TRIMBOW®Pressurized metered dose inhaler (pMDI) 2 inhalations bid | Drug | CHF5993 |
| CHF1535Also: FOSTER®Pressurized metered dose inhaler (pMDI) 2 inhalations bid | Drug | CHF1535 |
| Matched placeboPressurized metered dose inhaler (pMDI) 2 inhalations bid | Other | Matched placebo |
Primary outcome
Inspiratory capacity (IC) prior to Constant Work Rate Cycle Ergometry (CWRCE) test
Time frame: 3 weeks of treatment
Change from baseline in 2-hour post-dose
2 secondary outcomes
IC at Isotime, defined as the shortest CWRCE test duration among baseline and end of treatment period.
Time frame: 3 weeks of treatment
Exercise endurance time (EET)
Time frame: 3 weeks of 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 24 Mar 2023.
- Derived from this study: PubMed 39420338Watz H, Kirsten AM, Ludwig-Sengpiel A, Krull M, Mroz RM, Georges G, Varoli G, Charretier R, Cortellini M, Vele A, Galkin D. Effects of inhaled beclometasone dipropionate/formoterol fumarate/glycopyrronium vs. beclometasone dipropionate/formoterol fumarate and placebo on lung hyperinflation and exercise endurance in chronic obstructive pulmonary disease: a randomised controlled trial. Respir Res. 2024 Oct 17;25(1):378. doi: 10.1186/s12931-024-02993-x.
- 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.
Henrik Watz, MD study director
Pulmonary Research Institute at LungenClinic Grosshansdorf, German Center for Lung Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CHF5993 and CHF1535 in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 1 site in Germany.
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 14 inclusion and 11 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 24 Mar 2023. 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 Germany. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Inspiratory capacity (IC) prior to Constant Work Rate Cycle Ergometry (CWRCE) test (time frame: 3 weeks of 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 NCT05097014, 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 24 Mar 2023.