What next?
What next?
About this study
This clinical trial is designed to see if a new drug called LTI-03 can help people with IPF.
‘The aim is to understand if the study drug is well tolerated and how it affects the body.’
People affected by IPF currently have limited treatment options to slow the progression of disease. New research studies are needed to learn about better treatment options.
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?
People who take part in this study will be randomly assigned to one oftwo groups.
Group 1: the active group, who will receive the potential new drug.
Or
Group 2: the placebo group, where no active drug ingredients are given.
Both groups will have treatment for 14 days. They will use an inhaler each day.
Medical tests will be performed throughout the study to learn how the drug affects the body and lungs.
These will include: blood tests, pulmonary function tests, bronchoscopy, and standard safety assessments such as physical examination, vital signs and electrocardiogram (ECGs).
People who take part in the study will go to the hospital once a week for tests and monitoring. The research team will telephone participants in between visits to find out how they are doing.
Participants and the researchers will not know which group they are in until the end of the study. This is to help show the true effects of the new drug.
Summary of involvement
Taking part for 21 days
Taking either a new drug or placebo using an inhaler
Medical tests such as blood tests, pulmonary function tests, bronchoscopy, and standard safety assessments
Can I take part?
You may be able to take part if you have a diagnosis of IPF and are 40 years old and over. You must have received a diagnosis of IPF within the last 3 years. You cannot be taking antifibrotics. The researchers are looking for patients who have either:
• just been diagnosed and have not started treatment yet
• patients who are waiting to start treatment
• patients who could not tolerate current antifibrotic treatment.
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 clinical trial 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.
Aged 40 years and over
Able and willing to provide informed consent
Diagnosis of IPF within the last 3 years
Specific lung function criteria, that would be assessed by the research team.
You do not have IPF
Evidence of COPD, asthma or another serious medical condition
Treatment with antifibrotic medication (nintedanib or pirfenidone) within the last 2 months
Any vaccination within 2 weeks of taking part in the study
Pregnant or breastfeeding
What difference could taking part make?
Taking part in this clinical trial will help researchers to understand the potential effects of the new drug and how it impacts the body. The study will help to see if it has the potential to help 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
London
Newcastle
Edinburgh
How to take part
Please speak to your medical team about taking part, or contact the research team directly, to express your interests.
Further information
The summary on this page 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.
LTI-03-1002@lungtx.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