A Trial to Learn More About CHF5993 (Trimbow) with a Novel Propellant as Treatment for Asthma
About the TRECOS Trial
The TRECOS trial will be investigating the environmental impacts of asthma medication propellants by testing the safety and efficacy of 2 types of inhalers (HFA-134a and HFA-152a) with the approved asthma medication, CHF5993. HFA-134a is a hydrofluorocarbon (HFC) propellant, currently a widely used asthma inhaler propellant, which negatively impacts air quality and contributes to rising greenhouse gas emissions. There are currently an estimated 5 million inhalers in the EU that use HFCs as the propellant. ¹ HFA-152a is a new propellant with significantly less global warming impact and is overall safer for the environment.
The study will seek to learn if inhalers using the HFA-152a propellant will be safe and effective in treating asthma, while reducing greenhouse gas emissions. The other goal is to learn about any medical issues the participants might have after taking CHF5993 with either the HFA-134a or HFA-152a propellant, thereby contributing to a more comprehensive evaluation of the medications’ clinical safety and environmental impact.
In this trial, participants will be assigned randomly to get CHF5993 with either HFA-134a or HFA152a propellant. The participants, trial doctors, and trial staff will not know during the trial which inhaler the participants are using. This approach will help make sure that the effects of each of the inhalers are measured accurately and equally.
Estimated Enrolment
Approximately 513 Participants
Phase
Phase 3Eligibility Criteria
Participants must:
Inclusion Criteria
Participants must
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Be from 18 to 75 years old.
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Have had asthma for at least 6 months.
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Must have been diagnosed with asthma before the age of 50.
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Be on 2 asthma medications: an ‘inhaled corticosteroid’ (anti-inflammatory medicines that reduces swelling of the airways) and a ‘long-acting beta agonists’ (a type of medicine that relaxes muscles in the airway) for at least 4 weeks before the start of the trial.
Participants must not:
Exclusion Criteria
Participants must not
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Have a history of life-threatening asthma attacks in the last 6 months.
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Have had an asthma attack in the last 4 weeks that needed to be treated with systemic corticosteroids (anti-inflammatory medicines affecting the whole body, given by mouth or injections).
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Have had treatment with certain asthma medications.
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Have a lung condition other than asthma.
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Have health conditions such as cancer, yeast infection in the mouth or throat, or a history of alcohol or drug abuse.
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Be pregnant or breastfeeding.
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Have smoked in the past 12 months.
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Have used e-cigarettes in the past 6 months.
Study locations
Click here to see the full list of eligibility criteria.
About the Condition
Asthma is a long-term health issue that leads to difficulty breathing, a tight feeling in the chest, coughing and a whistling sound while breathing, known as wheezing. It is caused when the airways in your lungs, become swollen and narrow, making it difficult for air to get to your lungs.
Asthma does not have a cure, however, some people with asthma can manage it using medications, but for others, it may be harder to control. In such cases, they experience frequently waking up during the night, difficulty with everyday activities, and experiencing frequent and severe asthma attacks, despite using treatments.
Researchers are looking for other ways to deliver medication to treat moderate to severe asthma. The inhaled medication, CHF5993 helps ease asthma symptoms by reducing swelling and keeping the airways open. In this trial, researchers are studying 2 types of inhalers (different propellants) used to deliver the approved asthma medication CHF5993 (Trimbow).
What Will Happen in This Trial
The trial will be broken into multiple phases, please review the diagram below that shows the site visits and timing of those visits and video calls. Participants will have 7 total visits (6 on-site and 1 via call) over a period of 16 weeks.
See below for definitions of Screening and Randomisation.
Frequently Asked Questions (FAQs)
Glossary of Important Terms
1. HFA-134a (hydrofluoroalkane-134a) - a propellant or spray used in inhalers to help deliver medicine to the lungs for respiratory treatments.
2. HFA-152a (hydrofluoroalkane-152a) - a propellant or spray used in inhalers to help deliver medicine to the lungs for respiratory treatments.
3. Hydrofluorocarbon (HCF) - A type of organic compound used as a propellant in inhalers. HFCs are chosen as they do not deplete the ozone layer, unlike older chlorofluorocarbons (CFCs)
4. Efficacy - the ability of a medicine or a treatment to produce the desired therapeutic effect under ideal conditions, such as clinical trial
5. Propellant- A substance used in inhalers to help deliver the medication to the lungs.
6. Corticosteroid - Corticosteroids are a class of medications with anti-inflammatory properties, commonly used to treat conditions ranging from autoimmune disorders to respiratory diseases like asthma
7. Anti-inflammatory - substances, such as medications, that reduce inflammation and swelling, and alleviate pain in various conditions, including arthritis and respiratory disorders
8. Long-acting beta agonists - medications that help open up airways in the lungs for an extended period, making breathing easier, and they are often used to manage conditions like asthma and chronic obstructive pulmonary disease (COPD)
9. Peak expiratory flow (PEF) - a measure of how fast a person can breathe out air, helping to assess the function of their lungs and monitor conditions like asthma
10. Clinical trial - a research study involving people to test the safety and effectiveness of new medical treatments, medicines, or interventions, helping to determine if they are suitable for widespread use
11. Placebo - a harmless substance or treatment with no active ingredients that is given to participants in a study, often as a control, to help researchers compare the effects of a real treatment against the effects of believing one is receiving treatment
12. Electronic Diary - a digital journal that participants in a clinical trial use to record and share information about their health, symptoms, or experiences in real-time
13. Protocol - protocol for a clinical trial is like a step-by-step guide that tells everyone involved, from doctors to participants, how the study will work, what needs to be done, and how to keep everything fair and accurate
14. Randomisation - Randomisation is a 50/50 chance to decide who gets the study treatment and who gets the placebo in a clinical trial, ensuring that each participant has an equal chance.
15. Screening - Also known as the selection visit, the Study Doctor will check to see if you are suitable for participating in the study.
Travel Support
The sponsor will reimburse patients all reasonable costs they may have due to study participation (e.g. travel to the Study Centre visits). More details about this will be explained by the trial site and included in your informed consent form. Please ask site staff about travel support and other support offered for this trial.
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