Tests an inhaled bronchodilator and steroid combination in chronic obstructive pulmonary disease
Studies how an inhaled medicine affects breathing in adults with stable COPD.
Plain-language title generated from the registry record
Registry title: Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
Key facts
- Where
- Grenoble Cedex 9, Lille, and Paris, FranceSee the 3 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT06110403, who can take part
Where in France
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Centre Hospitalier Universitaire de LilleLille, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Lille
- Trial code
- NCT06110403EU 2024-514097-52-00
- Record updated
- 18 December 2025
- Original description
Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variabilityRead full original descriptionShow less
Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
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
Inclusion: 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: Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening; Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids; History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome); Clinically relevant respiratory conditions (other than COPD); Hepatic impairment; Any type of cancer within 5 years; 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); Severe renal impairment eGFR < 30; Woman of childbearing age without effective contraception; 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); Pregnancy or breastfeeding; Patients under guardianship; Refuse or incapacity to give an informed consent; Absence of social insurance.