Actively Recruiting
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
Led by University Hospital, Lille · Updated on 2025-12-18
35
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Men or women aged 40 to 75 years inclusive at enrollment
- Confirmed COPD diagnosis with post-bronchodilator FEV1/FVC less than 0.70
- Post-bronchodilator FEV1 between 30% and 70% of predicted normal at screening
- Smoking history of more than 10 pack-years
- Significant breathlessness with a modified Medical Research Council (mMRC) score of 2 or higher
You will not qualify if you...
- History or current diagnosis of asthma or asthma-COPD overlap syndrome
- Respiratory infection or COPD exacerbation within 6 weeks prior to screening (2 months if hospitalization occurred)
- Significant cardiovascular conditions, including unstable angina, recent heart attack or surgery within 6 months, severe heart failure (NYHA class III/IV), structural heart disease, recent symptomatic arrhythmia, certain heart conduction blocks unless paced, sinus node dysfunction, ventricular pre-excitation, prolonged QTcF interval, significant ECG abnormalities, bradycardia below 45 bpm, or uncontrolled high blood pressure
- Other clinically relevant respiratory diseases besides COPD
- Severe kidney impairment with eGFR less than 30
- Liver impairment
- Untreated narrow-angle glaucoma
- Symptomatic prostate enlargement or significant bladder obstruction
- Inability to perform lung function and breathing tests required by the study
- Contraindications to LABA, LAMA, or inhaled corticosteroids
- Pregnancy or breastfeeding
- Women of childbearing age without effective contraception
- Any cancer diagnosis within the past 5 years
- Under legal guardianship
- Unable or unwilling to give informed consent
- Lack of social insurance coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Lille
Lille, France
Actively Recruiting
Research Team
T
Thierry PEREZ, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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