What next?
What next?
About this study
ASPIRE IPF is a Phase 2b trial looking at the impact of a new oral investigational drug, buloxibutid, for people with idiopathic pulmonary fibrosis (IPF). The study will look at how the drug impacts ability to breathe, along with other important measures like safety and quality of life.
Buloxibutid is thought to activate a natural repair system that may help to reduce scar formation (fibrosis) in the lungs of people with IPF.
The aim of this study is to understand more about the effects of buloxibutid on people with IPF and how it may impact their lung function.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
At the start of the trial, you will be assessed. Your medical history will be reviewed to make sure that you are suitable for the trial and that taking part is right for you.
If you are suitable to take part in the ASPIRE trial and it is right for you and you provide consent, you will be asked to take the buloxibutid drug or a placebo twice a day for one year. A placebo will look like the buloxibutid, but will not contain any active ingredient; it is sometimes referred to as a dummy drug.
This study is a double-blind trial, which means that you won't be told if you are receiving buloxibutid or a placebo. The trial is set up in a way that your doctor won't know which group you are in until the end of the study. This ensures that the results are not accidently influenced in any way.
There are 3 different phases of the study:
- Screening period of up to 6 weeks
- Treatment period for 52-weeks
- Follow-up period of 2-4 weeks at the end of the 52-weeks of treatment.
You will have 8 in-person visits to the hospital, as well as 8 phone or video calls with a member of the trial team to monitor your health and wellbeing.
To help researchers understand more about the drug and its impact you will be asked to have various medical assessments and to complete questionnaires throughout the trial.
You will be reimbursed for reasonable travel and meal expenses related to attending the trial site clinic visits.
Summary of involvement
Study duration is at least 1 year
Taking either the buloxibutid or a placebo tablet twice per day
Medical assessments including lung function tests
Questionnaires
Can I take part?
You may be able to take part if you are over the age of 40 and have a diagnosis of IPF. You may still be able to take part if you are currently taking nintedanib.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see the main criteria list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point without this effecting your usual care or treatment.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find out more about other research opportunities visit our research finder main page.
You have been diagnosed with IPF
You are aged 40 years and over
Your breathing function meets the required levels
OR
You are not having any treatment for your IPF
More detailed criteria will be assessed by the research team
You have another serious health condition
You have had cancer within the last five years
You have had treatment with pirfenidone within the last 8 weeks
More detailed criteria will be assessed by the research team
What difference could taking part make?
There are currently a few ways to help slow down the progression of IPF. New research studies, such as this clinical trial, are needed to gain valuable knowledge that will help to find better and more effective treatment options.
Where does the study take place?
Study locations
Birmingham
London
Manchester (not yet open to recruitment)
Oxford (not yet open to recruitment)
How to take part
If you would like more information about taking part in this study or any other research, please speak to your IPF healthcare team. You can also find out more information by visiting the ASPIRE website.
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
info@aspire-ipf.comThis study is supported by
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org