Next Generation Propellant study
Research type
Research Study
Full title
A Randomized, Double-Blind, 12-Week (with an Extension to 52 weeks in a subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF delivered by MDI HFA in Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
1006119
Contact name
Krishna Varsani
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-001476-33
Clinicaltrials.gov Identifier
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a common problem that often results in sudden episodes of worsening symptoms beyond normal day-to-day variations which are called exacerbations. Metered dose inhalers (MDIs) are the most common type of devices used to deliver medication(s) during treatment of patients with COPD or asthma.
A critical component of MDIs formulation is the propellant (liquified compressed gas) which facilitates actuation of the device and subsequent delivery of the medication(s) to the lungs. Currently used MDIs are using propellant gases called hydrofluoroalkanes (HFA). Since their introduction, HFA-MDIs have been safely used by millions of people, primarily for the treatment of respiratory diseases such as COPD. While MDI use accounts for a very small proportion of global HFA emissions, it is desirable to replace the currently used propellant gases with more environment-friendly alternatives, without compromising treatment results.
AstraZeneca is therefore evaluating an alternative propellant called Hydrofluoroolefin (HFO), as it has a near-zero Global Warming Potential (GWP) and is more friendly to the environment than currently used HFA. In addition, it has very similar physical properties to HFA which will ensure comparable performance of the delivery of the BGF dose in the MDI product.
The purpose of the study is to assess the safety and tolerability of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) delivered by MDI HFO compared to BGF delivered by MDI HFA (COPD approved formulation) in symptomatic patients with moderate to very severe COPD.
The study will examine symptomatic patients with moderate to very severe COPD, currently being treated for at least 6 weeks prior to screening with at least two approved COPD standard inhaled maintenance therapies (dual or triple, open or fixed-dose combinations) for the management of their COPD.
"The D5985C00003 study tested safety of a novel inhaler propellant (excipient) called HFO. This propellant has near zero global warming potential. HFO is being developed to replace the current propellant, HFA, a green-house gas. Breztri MDI HFO is currently an unapproved, unlicenced product that is still under development by AZ.
The D5985C00003 study was included in the Breztri Next Generation Propellant submission package to EMA and MHRA and will be of public interest. Contingent on health authority feedback, it is possible that post-hoc analyses of the study data will be needed to support approval of Breztri MDI HFO. Therefore, the Global Product Team requests that posting of final results are deferred until and after all analyses are complete and not before anticipated feedback date from regulatory authorities (end July 2025). Consequently, a 5-month delay to posting is required."REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0168
Date of REC Opinion
7 Sep 2022
REC opinion
Further Information Favourable Opinion