BridgeMD
The efficacy and the safety of two doses of CHF6001 for the treatment of Chronic Obstructive Pulmonary Disease (COPD)
EU CTIS ID: 2023-510175-60-00
What this study is testing
To evaluate the efficacy of two doses of CHF6001 add-on to maintenance triple therapy (ICS, LABA, LAMA) to reduce the rate of moderate and severe exacerbations after 52 weeks of treatment in comparison with maintenance triple therapy (i.e. placebo arm).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Males and females aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
- 10.Subjects are willing and able to be trained to use correctly the electronic devices with COPD questionnaires, to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres etc.) and ability to understand the risks involved.
- 2. Females are eligible to enter the study if they are of a.non-childbearing potential or b.childbearing potential, they must have a negative pregnancy test at screening and must agree to use one or more of the acceptable contraceptive measures.
- 3. Subjects with an established diagnosis of COPD with chronic bronchitis.
- 4. 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.
- 5. A post-bronchodilator FEV1 < 60% of the subject predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 after 400μg (4 puffs x 100μg) of salbutamol pMDI or equivalent dose of albuterol pMDI in the US.
You likely can't join if
- 1.Subjects with a diagnosis of current asthma.
- 10.Subjects with active cancer or a history of cancer (other than the lung) with full recovery less than 1 year after completing cancer therapy, or any untreated localized carcinoma.
- 11.Subjects with a history of allergy or hypersensitivity to anticholinergics, β2-agonists, corticosteroids, PDE-4 inhibitors or any of the excipients contained in any of the formulations used in the trial or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the investigator's opinion would contra-indicate study participation.
- 12.Subjects under Roflumilast treatment within 6 months before study entry.
- 13.Subjects with a diagnosis of depression, generalized anxiety disorder, suicidal ideation or behavior that might, according to the investigator judgement, place the subject at undue risk.
- 14.Subjects who have clinically significant cardiovascular condition.
See the full eligibility criteria
Who can join
- 1. Males and females aged ≥ 40 years with written informed consent obtained prior to any study-related procedure.
- 10.Subjects are willing and able to be trained to use correctly the electronic devices with COPD questionnaires, to understand and to perform required outcome measurements of the protocol (e.g. spirometry manoeuvres etc.) and ability to understand the risks involved.
- 2. Females are eligible to enter the study if they are of a.non-childbearing potential or b.childbearing potential, they must have a negative pregnancy test at screening and must agree to use one or more of the acceptable contraceptive measures.
- 3. Subjects with an established diagnosis of COPD with chronic bronchitis.
- 4. 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.
- 5. A post-bronchodilator FEV1 < 60% of the subject predicted normal value and a post-bronchodilator FEV1/FVC ratio < 0.7 after 400μg (4 puffs x 100μg) of salbutamol pMDI or equivalent dose of albuterol pMDI in the US.
- 6. A documented history (e.g. medical record verification) of at least one moderate or severe COPD exacerbation in previous year.
- 7.Symptomatic subject at screening defined as having a CAT score ≥ 10.
- 8. Subjects prescribed with maintenance triple therapy (free or fixed combination of ICS, LABA, LAMA) according to GOLD 2020 recommendations for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to the screening visit.
- 9.Subjects are willing and able to be trained to use correctly the DPI inhalers (NEXThaler®).
What rules you out
- 1.Subjects with a diagnosis of current asthma.
- 10.Subjects with active cancer or a history of cancer (other than the lung) with full recovery less than 1 year after completing cancer therapy, or any untreated localized carcinoma.
- 11.Subjects with a history of allergy or hypersensitivity to anticholinergics, β2-agonists, corticosteroids, PDE-4 inhibitors or any of the excipients contained in any of the formulations used in the trial or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the investigator's opinion would contra-indicate study participation.
- 12.Subjects under Roflumilast treatment within 6 months before study entry.
- 13.Subjects with a diagnosis of depression, generalized anxiety disorder, suicidal ideation or behavior that might, according to the investigator judgement, place the subject at undue risk.
- 14.Subjects who have clinically significant cardiovascular condition.
- 15.An abnormal and clinically significant 12-lead ECG finding in relation to the subject's medical history that results in active medical problem which may impact the safety of the subject according to investigator's judgement.
- 16.Subjects with a significant neurological disease including transient ischemic attack (TIA), stroke, seizure disorder or behavioural disturbances that in investigator's opinion, would place the subject at risk by participating to the study.
- 2.Subjects with a moderate or severe COPD exacerbation 4 weeks prior to study entry and during run-in period.
- 3.Pregnant and lactating women.
- 4.Subjects requiring long term (at least 15 hours daily) oxygen therapy for chronic hypoxemia.
- 5.Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
- 6.Subjects with primary diagnosis of emphysema not related to COPD.
- 7.Subjects with clinically significant respiratory disorders other than COPD.
- 8.Subjects with lung volume reduction surgery.
- 9.Subjects having lung cancer or a history of lung cancer or lung cancer with full recovery less than 1 year after completing cancer therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- South Africa
- Chile
- Australia
- Bosnia and Herzegovina
- North Macedonia
- Russian Federation
- Mexico
- China
- United Kingdom
- New Zealand
- Albania
- United States
- Israel
- Turkey
- Argentina
- Ukraine
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; South Africa; Chile; Australia; Bosnia and Herzegovina; North Macedonia and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.