NCT06110403 Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
| NCT ID | NCT06110403 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital, Lille |
| Condition | Copd |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2023-09-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome) * 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: * Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months. * Congestive heart failure New York Heart Association (NYHA) class III/IV. * Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease). * Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia. * 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. * Sinus node dysfunction with pauses. * Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome. * QTcF interval \>470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/\[RR1/3\]). * Any other ECG abnormality deemed clinically significant by the Investigator. * Bradycardia with ventricular rate \< 45 bpm. * 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) * Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids * 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
Contact & Investigator
Thierry PEREZ, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT06110403 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Copd. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06110403 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06110403 currently recruiting?
Yes, NCT06110403 is actively recruiting participants. Contact the research team at thierry.perez@chu-lille.fr for enrollment information.
Where is the NCT06110403 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT06110403 clinical trial?
NCT06110403 is sponsored by University Hospital, Lille. The principal investigator is Thierry PEREZ, MD at University Hospital, Lille. The trial plans to enroll 35 participants.
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