This study is currently recruiting participants. Expected to close December 2023.
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.
Trial type: Therapeutic, taking a trial drug
Trial phase: I
Recruitment aim: 24 participants
Duration of participation: 21 days
What is involved?
People who take part in this study will be randomly assigned to one of two groups.
Group 1: the active group, who will receive the potential new drug.
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 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.
Both 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 inhalers
* 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.
You may be able to join this study if all of these apply:
* 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 will not be able to join the study of any of the following applies:
* You do not have IPF
* Evidence of COPD, asthma or another serious medical condition
* Treatment of antifibrotic medication (nintedanib or pirfenidone) within the last 2 months
* Any vaccination within 2 weeks of taking part in the study
* Pregnant or breastfeeding women
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?
How to take part?
To find out more about taking part in this study, or if you have any questions, please speak to your healthcare team or contact the research team directly. The researchers can be contacted directly via:LTIemail@example.com
The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via this link and by contacting the research team.
This study is supported by
Study ID number: NCT05954988
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 firstname.lastname@example.org
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