What next?
What next?
About this study
The AIR Trial is investigating a new drug called compound 21 (C21) in people with IPF. This is a single treatment arm study, where all participants will take the drug.
Alveolar Epithelial Type II (AT2) cells, play a vital role in maintaining and repairing healthy lung tissue. People with IPF may have fewer of these AT2 cells, or the cells may not function correctly, which can promote scarring of the lungs. The new drug can attach to the surface of these cells and help to restore their normal function within the lungs.
The aim of the AIR Trial is to see if C21 can stabilise lung function in people with IPF and slow progression of the condition.
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?
You will be asked to take the new drug twice per day for up to 36 weeks. Ongoing checks will be carried out by the researchers, to understand how your body responds to the drug. You will meet with the medical team every 12-weeks.
Summary of involvement
Taking a drug for up to 36 weeks
Medical assessments such as blood tests every 12 weeks
Can I take part?
You may be able to take part if you have received a diagnosis of IPF within the last 3 years and are age 40 years and above.
You will not be eligible to take part if you have previously taken, or are currently taking, Nintedanib or Pirfenidone.
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 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.
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 our more about other research opportunities visit our research finder main page.
Diagnosis of IPF within the last 3 years
Aged 40 and above
High resolution computed tomography (HRCT) scan within the last 36 months
Fully vaccinated against COVID-19
There is a set criteria for lung function, but this must be discussed with the research team
Previous use of nintedanib or pirfenidone
Smoking within the last 6 month (including e-cigarettes)
Body mass index (BMI) greater than 35 or less than 18
IPF exacerbation within the last 3 months
Other serious medical conditions
Cancer within the past 5 years
Treatment with certain medications within the past 2 and 4 weeks, as listed by the researchers
Pregnant or breastfeeding females
Males or females who are not willing to use contraceptive methods
What difference could taking part make?
People affected by IPF currently have limited treatment options to slow the progression of disease. New research studies such as this one, are needed to gain valuable knowledge about potentially better treatment options.
Taking part in the AIR Trial will help researchers to assess the tolerability and potential benefits of a new drug, C21. The study will help to gain greater understanding of C21 and if it has the potential to slow or stop the loss of lung function in people with IPF.
Taking part in research has the potential to make a difference for people who have IPF now and for future generations.
Where does the study take place?
Study locations
Birmingham
London
Manchester
How to take part
Please discuss this with your healthcare team and Consultant in the first instance, to express your interest in the study and hearing about opportunities to take part in research.
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.
This 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