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A study evaluating the effect on lung function of an approved COPD treatment – a metered-dose inhaler using HFA propellant versus a metered-dose inhaler using a new HFO propellant

Study Status

Completed

Phase

Phase 3

Therapeutic Area

COPD

Overview

Chronic obstructive pulmonary disease (COPD) is a common disease affecting hundreds of millions of people worldwide. Metered-dose inhalers (MDIs) are key devices in COPD treatment, but current MDIs usually use HFA propellants, which are greenhouse gases that contribute to carbon emissions. In the context of increasingly strict environmental regulations, this study evaluates the efficacy and safety of an MDI using a new, more environmentally friendly HFO propellant compared with the current HFA-based formulation. The goal is to maintain treatment efficacy for COPD patients while reducing emissions and production costs, contributing to sustainable development.

Inclusion Criteria

Men and women aged 40–80 years with a diagnosis of COPD
Currently receiving or having received maintenance COPD therapy for at least 4 weeks prior to screening (including LABA, LAMA, LABA/LAMA, ICS/LABA, SABA/SAMA or SABA+SAMA combinations; or no treatment in the last 4 weeks)
Smoking history ≥10 pack-years (pack-years = number of packs smoked per day × number of years smoked)

Exclusion Criteria

History of asthma
COPD due to α1-antitrypsin deficiency
COPD exacerbation requiring systemic corticosteroids or antibiotics within the last 4 months
COPD exacerbation requiring hospitalization within the last 12 months
Acute respiratory infection within the last 4 weeks

PI

MSc, MD Cấn Thị Hằng – Department of Internal Medicine, Vinmec Times City Internation Hospital

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