What next?
What next?
About this study
A new experimental study drug called AGMB-447, is being tested for people with idiopathic pulmonary fibrosis (IPF).
AGMB-447 is in the early phases of testing to see what the impact is for people with IPF. The study drug is inhaled (administered via a nebuliser, and transforming the liquid medication into a fine mist to be inhaled over a few minutes), which helps to directly target the fibrotic lungs.
The drug is thought to reduce signals that are produced in the lungs and involved in the formation of lung scarring.
AGMB-447 is currently being tested in healthy participants. This is the first study with drug being tested for people with IPF. The researchers aim to understand whether the study drug is safe and well tolerated for people with IPF.
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 put into one of two groups. You will either be given the study drug, or be given a placebo. A placebo is a lookalike medication that contains no active ingredients of the drug (sometimes referred to as a dummy drug). You will not know if you have been given the drug or the placebo. 1 in 4 people taking part will recieve the placebo.
You will be asked to take the medication for two weeks via a nebuliser, which gives the drug in a mist form over a few minutes.
During the two weeks, you will be asked to attend the hospital daily for close monitoring, and have tests which will include lung bronchoscopies (a camera test that looks inside your lungs), blood tests, lung function tests (breathing tests), ECGs, and other tests that will monitor your safety.
You will be monitored for a maximum of 8 weeks in total.
There will be reimbursement for your time, travel, accommodation and expenses during the study.
Summary of involvement
Taking a drug or placebo via a nebuliser for 2 weeks
Daily visits to the hospital when taking the drug
Total monitoring for a maximum of 8 weeks
Blood tests
Lung function tests
Lung bronchoscopys
Other physical health monitoring tests
Can I take part?
You may be able to take part if you have a diagnosis of IPF and over the age of 40 years.
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 are age 40 years and above
You have had a diagnosis of IPF within the last 5 years
You are on a stable, and well tolerated dose of Nintedanib for at least 3 months
OR
You are not currently taking any antifibrotic medication. This includes those who have never received treatment and those who have stopped medication due to not tolerating the medication.
There are also lung function requirements which will be assessed by the research team.
You have a history or current diagnosis of a different condition that has had a significant impact on you and may interfere with the study. Your medical history will be assessed by the research team who will determine your ability to take part.
You have another lung condition or abnormalities that aren't related to your IPF diagnosis.
You have current heart problems or arrhythmias
You have current abnomalities in your liver function
You have had a respiratory tract infection within the last 4 weeks
You have had cancer within the last 5 years
What difference could taking part make?
Taking part in this study will help researchers to understand what happens when someone with IPF takes the study drug. This study will help to see if the drug is safe and well tolerated. It will provide information that will help researchers to see if it should move to the next phase of testing in a larger number of people with IPF.
Where does the study take place?
Study locations
Manchester
How to take part
Please speak to your healthcare team if you are interested in taking part in research. You can also contact the Medicines Evaluation Unit at 0161 946 5059.
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
This page provides a lay summary of the research study and does not contain all the information needed to inform decisions about taking part. Please speak to your medical team or the study research team in relation to specific details about the study.
Action for Pulmonary Fibrosis does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators. Every effort is made to ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org