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What next?
What next?
About this study
Pirfenidone is an approved treatment for pulmonary fibrosis in tablet form. Higher doses are needed for the ingredients of a tablet to reach the lungs. These high doses can be associated with significant side effects.
Initial studies in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) suggest that inhaled pirfenidone may reduce side effects and still help to slow the progression of the disease.
This study aims to investigate if inhaled pirfenidone reduces side effects and helps to slow the progression of the disease for people with PPF.
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 randomly put into 1 of 3 groups.
- Group 1 will be given a high dose of inhaled pirfenidone twice per day
- Group 2 will be given a low dose of inhaled pirfenidone twice per day
- Group 3 will be given a placebo twice per day. This is a look alike treatment and will not contain any pirfenidone.
The treatment is provided through a nebuliser. You will receive training for how to use this at the first hospital visit. You will have regular contact with the research team through telephone calls and hospital visits.
You will be asked to have lung function tests, high-resolution computed tomography (HRCT) scans and other medical monitoring at various points throughout the study. You will also be asked to complete questionnaires.
Summary of involvement
Using a nebuliser twice per day
Lung function tests
HRCT scans
Other medical monitoring
Questionnaires
Can I take part?
You may be able to take part if you have a diagnosis of Progressive Pulmonary Fibrosis (PPF) and are aged 18 years and older. You may be able to take part if you are currently prescribed 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 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 Progressive Pulmonary Fibrosis (PPF)
Aged 18 years or older
Meet spirometry test requirements and other study requirements explained by the study doctor.
You can be taking nintedanib if a stable dose is already prescribed by your doctor
Diagnosis of Idiopathic Pulmonary Fibrosis
Current or very recent treatment with oral pirfenidone
Significant liver or kidney disease
A greater extent of emphysema than fibrotic lung disease on CT scan
Significant non PPF disease such as cancer, very high blood pressure or a heart attack or unstable angina within the previous 6 months
Pulmonary Hypertension
What difference could taking part make?
Taking part in this study will help researchers to understand the effects of inhaled pirfenidone on people living with PPF.
Where does the study take place?
Study locations
Birmingham
Derry/Londonderry
Exeter
Hull
London
Leeds
Leicester
Manchester
Nottingham
Oxford
Wolverhampton
How to take part
If you would like to find out more about taking part or what research opportunities are available for you, we would encourage you to ask your healthcare team.
You can also find out more about the study on the Avalyn Pharma website, or email the research team directly via: MISTPPFStudy@avalynpharma.com if you have any specific questions about the study.
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.
MISTPPFStudy@avalynpharma.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