RecruitingPhase 1Phase 2NCT06110403

Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness

Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient


Sponsor

University Hospital, Lille

Enrollment

35 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination inhaled therapy (a long-acting bronchodilator plus corticosteroid) improves breathing, lung function, and the sensation of breathlessness in patients with moderate-to-severe COPD (chronic obstructive pulmonary disease). Researchers use specialized breathing tests and lung scans to measure improvements. **You may be eligible if...** - You are between 40 and 75 years old with confirmed COPD (based on breathing tests) - You have smoked for more than 10 pack-years - You experience significant breathlessness day-to-day **You may NOT be eligible if...** - You have asthma or asthma-COPD overlap - You had a respiratory infection or COPD flare-up in the last 6 weeks (or 2 months if it led to hospitalization) - You have significant heart problems (recent heart attack, severe heart failure, serious arrhythmia) - You have severe kidney or liver problems - You are pregnant or breastfeeding - You have had any cancer in the last 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTRIXEO AEROSPHERE

BGF 160 (Breztri Aerosphere™ in USA, Trixeo™ in France) Inhalation aerosol: pressurized metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) as an inhalation aerosol. Oral inhalation: 2 inhalations of BGF 160 twice daily for 30 days.


Locations(1)

CHU de Lille

Lille, France

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NCT06110403


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