The aim of this study is to collect information on the use of an investigational drug, called Atuliflapon, in adults who have moderate-to-severe asthma that they cannot control with current treatment alone. This investigational drug is a potential new oral treatment, taken in addition to your standard asthma medication, which can be swallowed at home with water.
The FLASH Study focuses on an area of clinical research called precision medicine. Precision medicine aims to provide an alternative to the common ‘one-size-fits-all approach’ of current prescription medicine, by instead identifying the right treatment, for the right person, at the right time.
Participants in the FLASH Study will receive an investigational drug called Atuliflapon, which is being developed as a potential treatment for asthma. It works by reducing substances in the body that can cause our airways to become inflamed. Airways are the pipes we use to breathe, and they become narrower during inflammation.
Atuliflapon is a tablet which you will swallow with water once a day and is taken in addition to your standard asthma medication.
Participation in the study could last up to 5 months. This includes the following:
Screening (2–4 weeks) – the study team will assess potential participants and confirm that they are able to join the study.
Main study (up to 16 weeks) – around 660 participants will be randomly assigned to Atuliflapon or placebo.
Safety follow-up (1 week) – participants will be asked to return to the study center to have some final tests.
A placebo looks like the investigational drug but contains no active ingredients.
You will be asked to attend several study center and one virtual visit throughout the study to have some medical tests and assessments.
You will also be asked to keep an electronic diary (smartphone) twice daily to record the following:
- Peak expiratory flow (a measure of how fast a person breathes out).
- Asthma symptoms.
- Use of any asthma reliever medication.
- Intake of study medication during the study treatment period.
One of the aims of this study is to find out whether Atuliflapon causes side effects. Atuliflapon has been investigated in previous clinical studies for coronary heart disease. During these studies, some participants experienced side effects such as dizziness, anemia, and cough. It is possible you may experience similar side effects during your own participation in the FLASH Study. The study doctor will discuss potential side effects with you.
During visits to the study center you will undergo medical tests and assessments. The purpose of these is to understand how your body is responding to Atuliflapon. These will include the following: