Clinical Trials for Pulmonary Fibrosis
There are currently 5 ongoing clinical trials studying new treatments for pulmonary fibrosis, a lung condition where tissue becomes thick and scarred. These trials are testing different approaches including inhaled medications, imaging techniques to better understand the disease, and oxygen therapy. Trials are being conducted across multiple European countries including Germany, Netherlands, France, Spain, Italy, Poland, and Belgium.
Clinical trial locations
- Belgium
- France
- Germany
- Italy
- Netherlands
- Study of Inhaled Pirfenidone for Patients with Progressive Pulmonary Fibrosis
- Study on PET/CT Imaging with [18F]-AlF-FAPI-74 for Identifying Fibrosis and Inflammation in Patients with Progressive Pulmonary Fibrosis
- Study on PET/CT Imaging with [18F]-AlF-FAPI-74 for Identifying Fibrosis and Inflammation in Patients with Progressive Pulmonary Fibrosis
- Poland
- Spain
- Study of Inhaled Pirfenidone for Patients with Progressive Pulmonary Fibrosis
- Study on the Effects of Inhaled Treprostinil for Patients with Progressive Pulmonary Fibrosis
- Study to evaluate oxygen therapy effects on physical activity in patients with fibrotic interstitial lung disease who experience low oxygen levels during exercise
Study of Inhaled Pirfenidone for Patients with Progressive Pulmonary Fibrosis
This trial is testing an inhaled form of pirfenidone called AP01 for people with progressive pulmonary fibrosis. The medication is delivered directly to the lungs through a device called an eFlow Nebuliser System, which turns the liquid medicine into a fine mist that can be breathed in.
Who can join: Adults aged 18 or older with progressive pulmonary fibrosis can participate if their lung function tests meet certain criteria. Specifically, their forced vital capacity must be at least 45% of normal, and other breathing tests must show adequate function. Some participants may already be taking nintedanib, but they must have been on a stable dose for at least 12 weeks. Those who previously stopped nintedanib must have discontinued it at least 12 weeks before joining.
Who cannot join: People with other lung diseases besides progressive pulmonary fibrosis, those who have had a lung transplant, or individuals currently in another clinical trial cannot participate. Pregnant or breastfeeding women, people with severe heart, liver, or kidney disease, and those with severe allergic reactions to the study medication are also excluded.
What the trial studies: The main goal is to see if inhaled pirfenidone can improve or maintain lung function over 52 weeks. Researchers will measure changes in forced vital capacity at regular intervals and monitor quality of life using specific questionnaires. The study will also use special lung scans to look at changes in lung scarring.
The medication being tested: Pirfenidone Solution for Inhalation (AP01) is an antifibrotic agent that works by reducing the production of certain proteins that cause inflammation and scarring in the lungs. By delivering the medication directly to the lungs through inhalation, researchers hope to achieve better results with potentially fewer side effects compared to oral forms.
Study on PET/CT Imaging with [18F]-AlF-FAPI-74 for Identifying Fibrosis and Inflammation in Patients with Progressive Pulmonary Fibrosis
This study uses a special imaging technique to help doctors better understand the type of lung changes occurring in progressive pulmonary fibrosis. The imaging involves a PET/CT scan using a substance called [18F]-AlF-FAPI-74 that highlights areas of active scarring and inflammation in the lungs.
Who can join: Adults 18 years or older with a new diagnosis of progressive pulmonary fibrosis can participate. At least 20% of their lung tissue must show abnormal changes from fibrosis or inflammation. They must also have a recommendation from a medical team to start treatment with either immunosuppressive drugs or antifibrotic medications.
Who cannot join: The trial does not specify detailed exclusion criteria in the provided information, but generally pregnant or breastfeeding women and people with severe allergic reactions to imaging agents would be excluded.
What the trial studies: The main goal is to determine if this imaging technique can effectively distinguish between active lung scarring and inflammation. This information could help doctors choose the most appropriate treatment for each patient. The study will measure how the imaging agent concentrates in different areas of the lungs and correlate this with other clinical information.
The imaging agent being tested: FAPI is a diagnostic radiopharmaceutical agent that targets fibroblast activation protein, which is often overexpressed in scarred lung tissue. When injected into the bloodstream, it helps create detailed images that show where active scarring is occurring in the lungs.
Study on the Effects of Inhaled Treprostinil for Patients with Progressive Pulmonary Fibrosis
This trial tests whether inhaled treprostinil can help slow down lung function decline in people with progressive pulmonary fibrosis. The medication is given through a nebulizer device that creates a mist for easy breathing. The study compares the effects of treprostinil with a placebo over one year.
Who can join: Adults 18 or older with progressive pulmonary fibrosis can participate if their lung scans show more than 10% fibrosis and their forced vital capacity is at least 45% of predicted. Participants must have shown worsening of their condition within 24 months, either through decreased lung function, worsening symptoms, or increased scarring on chest images. They can be taking nintedanib or pirfenidone, but not both together, and the dose must be stable for at least 90 days.
Who cannot join: People with other serious lung diseases, recent lung infections, planned surgeries, severe heart conditions, or certain medication interactions cannot participate. Pregnant or breastfeeding women and those unable to follow study procedures are also excluded.
What the trial studies: The primary focus is measuring changes in forced vital capacity at regular intervals over 52 weeks. Researchers will also monitor respiratory symptoms, quality of life, time to disease worsening, and overall survival rates. The study aims to determine if treprostinil can help slow disease progression and improve breathing.
The medication being tested: Treprostinil is a prostacyclin analog that works by dilating blood vessels in the lungs, which helps reduce blood pressure in lung arteries and improve oxygen flow. By delivering it directly to the lungs through inhalation, the medication can work more effectively where it is needed most.
Study on PET/CT Imaging with [18F]-AlF-FAPI-74 for Identifying Fibrosis and Inflammation in Patients with Progressive Pulmonary Fibrosis
This is another imaging study using the same PET/CT technique with [18F]-AlF-FAPI-74 to help doctors better understand lung changes in progressive pulmonary fibrosis. The goal is to distinguish between thickened, scarred tissue and inflamed, swollen tissue.
Who can join: Adults 18 years or older with a newly diagnosed progressive pulmonary fibrosis where at least 20% of lung tissue shows abnormal changes are eligible. Participants must have a medical team recommendation to begin treatment with either immunosuppressive or antifibrotic drugs.
Who cannot join: No specific exclusion criteria are listed for this trial in the provided information.
What the trial studies: The study examines how well PET/CT imaging with FAPI can identify different types of lung tissue changes. By injecting the imaging agent intravenously and taking detailed scans, researchers can measure the concentration of the agent in areas with active fibrosis and inflammation. This information helps determine what type of treatment might work best.
The imaging agent being tested: FAPI targets fibroblast activation protein, which is abundant in areas where lung tissue is actively scarring. The imaging agent binds to these areas, making them visible on PET/CT scans and helping doctors understand the nature and extent of lung damage.
Study to evaluate oxygen therapy effects on physical activity in patients with fibrotic interstitial lung disease who experience low oxygen levels during exercise
This study examines whether supplemental oxygen therapy can help people with fibrotic interstitial lung disease stay more physically active. The trial focuses on patients whose oxygen levels drop significantly during physical activity.
Who can join: Adults 18 or older with fibrotic interstitial lung disease confirmed by chest CT scan can participate. They must show low oxygen levels during exercise, specifically dropping to 88% or lower during a 6-minute walking test while breathing room air. Their breathing symptoms must be stable for at least two weeks before joining.
Who cannot join: People who cannot perform physical activity, those with unstable heart conditions or severe pulmonary hypertension, and individuals already using home oxygen therapy cannot participate. Pregnant or breastfeeding women, those with cognitive impairment, and people unable to complete the 6-minute walk test are also excluded.
What the trial studies: The main goal is to measure how oxygen therapy affects daily physical activity by tracking the number of steps patients take each day using a special device called an accelerometer. The study runs for three months and also evaluates breathing difficulties, quality of life, anxiety, depression levels, and certain blood markers related to oxidative stress.
The treatment being tested: Oxygen therapy provides additional oxygen through a nasal cannula or mask, helping patients breathe better during physical activities. This supplemental oxygen is particularly important for patients whose oxygen levels drop during exercise, as it allows them to remain more active and potentially improve their quality of life.
Summary
These five clinical trials represent different approaches to understanding and treating pulmonary fibrosis. Two trials focus on inhaled medications that deliver treatment directly to the lungs, two use advanced imaging to better understand the disease, and one evaluates oxygen therapy for maintaining physical activity.
The trials are concentrated primarily in Western European countries, with the Netherlands hosting three studies and Germany, France, Spain, Italy, and Belgium each hosting two studies. Poland has one trial. This distribution reflects the European focus of current research efforts in this condition.
Three main types of interventions are being studied: antifibrotic medications like pirfenidone and treprostinil that aim to slow lung scarring, diagnostic imaging with FAPI to better identify disease patterns, and supportive oxygen therapy to help maintain quality of life. Most medication trials run for 52 weeks, while the oxygen therapy study lasts three months. These varied approaches suggest researchers are exploring both disease-modifying treatments and supportive care strategies to help people living with this challenging lung condition.
