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Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
EU CTIS ID: 2024-514097-52-00
What this study is testing
To evaluate the change in ventilation pattern complexity and variability after 1 month of treatment by BGF 160
- Therapeutic use (Phase IV)
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
- Provision of signed informed consent prior to any study specific procedure
- Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1)
- Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator 30 % < FEV1 <70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening
- Smoking history > 10 pack-years
- Baseline significant dyspnea with a mMRC ≥ 2
You likely can't join if
- History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome)
- Any contraindication or allergy to LABA or LAMA drugs or to Inhaled corticosteroids
- Treatment by an azole systemic antifungal (itraconazole, fluconazole…)
- Treatment by a protease inhibitor or cobicistat for HIV
- Pregnancy or breastfeeding
- Woman of childbearing age without effective contraception
See the full eligibility criteria
- Provision of signed informed consent prior to any study specific procedure
- Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1)
- Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator 30 % < FEV1 <70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening
- Smoking history > 10 pack-years
- Baseline significant dyspnea with a mMRC ≥ 2
- History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome)
- Any contraindication or allergy to LABA or LAMA drugs or to Inhaled corticosteroids
- Treatment by an azole systemic antifungal (itraconazole, fluconazole…)
- Treatment by a protease inhibitor or cobicistat for HIV
- Pregnancy or breastfeeding
- Woman of childbearing age without effective contraception
- Any type of cancer within 5 years
- Patients under guardianship
- Refuse or incapacity to give an informed consent
- Absence of social insurance
- Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening
- Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters: o Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months. o Congestive heart failure New York Heart Association (NYHA) class III/IV. o Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease). o Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia. o Left bundle branch or high-degree AV block (second degree AV block type 2 and third degree AV block) unless the patient has a pacemaker. o Sinus node dysfunction with pauses. o Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome. o QTcF interval >470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/[RR1/3]). o Any other ECG abnormality deemed clinically significant by the Investigator. o Bradycardia with ventricular rate < 45 bpm. o Uncontrolled hypertension (> 165/95 mmHg).
- Clinically relevant respiratory conditions (other than COPD)
- Severe renal impairment eGFR < 30
- Hepatic impairment
- Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated.
- Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant
- Patients not able to perform IOS, spirometry, plethysmography, or VT acquisition (10 min)
The study team makes the final eligibility decision.
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.
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.