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Ongoing Clinical Trials for Interstitial Lung Disease

This article provides detailed information about 13 ongoing clinical trials for interstitial lung disease, a group of disorders causing progressive scarring of lung tissue. These trials are testing various treatments including immunosuppressants, anti-fibrotic medications, stem cell therapy, and innovative imaging techniques across multiple countries in Europe.

Clinical trial locations

Study Comparing Cyclophosphamide, Azathioprine, and Tacrolimus for Patients with Antisynthetase Syndrome-Related Interstitial Lung Disease

This trial is comparing two different treatment approaches for antisynthetase syndrome-related interstitial lung disease, a condition where lung inflammation and scarring occur in people with a rare autoimmune disorder. One group of patients receives a combination of cyclophosphamide and azathioprine, while the other receives tacrolimus. All three medications work by suppressing the immune system to reduce lung inflammation.

Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of antisynthetase syndrome based on positive tests for specific antibodies (anti-Jo-1, anti-PL7, anti-PL12, anti-EJ, or anti-OJ). They must have moderate to severe lung disease confirmed by lung scans, with lung function tests showing forced vital capacity less than 80% and/or corrected diffusing capacity less than 70%. Women of childbearing age need a negative pregnancy test and must use effective birth control during the study and for 12 months after treatment ends.

Main exclusion criteria: Patients without antisynthetase syndrome-related lung disease, those outside the specified age range, vulnerable populations, and those not meeting other specific health criteria cannot participate.

Trial focus: The study monitors patients for up to 12 months to measure the time until the first lung disease-related event occurs. Secondary evaluations include changes in walking distance, lung function tests, and quality of life assessments. This trial takes place in France.

Investigational drugs: Cyclophosphamide and azathioprine are both immunosuppressant medications that reduce inflammation by suppressing immune system activity. Tacrolimus is another immunosuppressant that works by decreasing immune system activity to help control lung disease and improve breathing.

Study of tezepelumab in patients with progressive pulmonary fibrosis and increased eosinophil levels in blood

This German trial tests tezepelumab in patients with progressive lung scarring who also have elevated levels of eosinophils, a type of white blood cell, in their blood. The medication is given as an injection under the skin at a dose of 210 mg.

Main inclusion criteria: Participants must be between 18 and 75 years old with a diagnosis of idiopathic pulmonary fibrosis, progressive pulmonary fibrosis with chronic eosinophilic pneumonia, fibrotic hypersensitivity pneumonitis, or connective tissue disease-related lung disease. They must be taking stable doses of anti-scarring medication (nintedanib or pirfenidone) for at least 2 months and have elevated eosinophil levels in blood or lung fluid tests within the past 12 months.

Main exclusion criteria: People cannot participate if they are under 18 or over 75, pregnant or breastfeeding, have previously received tezepelumab, have active tuberculosis, cancer history within the past 5 years, severe liver or kidney disease, uncontrolled high blood pressure, recent heart problems or stroke, active infections, substance abuse issues, or inability to perform required breathing tests.

Trial focus: The primary goal is to determine if tezepelumab can reduce eosinophil counts in the blood after 24 weeks of treatment compared to placebo. The study continues monitoring for 56 weeks to evaluate long-term effects on lung function and overall health.

Investigational drug: Tezepelumab is a monoclonal antibody that targets a protein called thymic stromal lymphopoietin (TSLP). It aims to reduce eosinophil levels and may help slow down the progression of lung fibrosis in patients with elevated eosinophil counts.

Study on Long-Term Safety of Inhaled Treprostinil for Patients with Fibrotic Lung Disease

This multi-country trial (Denmark, Germany, Spain, Belgium, Italy, France, Netherlands) evaluates the long-term safety of inhaled treprostinil delivered through a nebulizer system. The medication is turned into a mist that patients breathe directly into their lungs.

Main inclusion criteria: Patients must have participated in one of three previous treprostinil studies (RIN-PF-301, RIN-PF-303, or RIN-PF-305) and either completed all scheduled visits or were part of the study when it stopped for non-safety reasons. Women of childbearing age must not be pregnant or breastfeeding and must agree to use two highly effective forms of birth control during the study and for 30 days after stopping treatment.

Main exclusion criteria: Patients with lung diseases not related to fibrosis, those without a diagnosis of idiopathic pulmonary fibrosis or progressive pulmonary fibrosis, people outside the specified age range, those unable to follow study procedures, and vulnerable populations are excluded.

Trial focus: The study monitors long-term safety and tolerability of inhaled treprostinil while assessing changes in lung function, time to clinical worsening, and overall survival. The trial is estimated to conclude by May 31, 2027.

Investigational drug: Treprostinil is a prostacyclin analog that works by dilating blood vessels in the lungs, reducing blood pressure, and improving blood flow. It aims to improve lung function and alleviate symptoms associated with fibrotic lung conditions.

Study on Senicapoc for Patients with Progressive Fibrotic Interstitial Lung Disease to Prevent Disease Progression

This trial in Denmark and Estonia tests senicapoc compared to placebo in patients with progressive fibrotic lung disease or idiopathic pulmonary fibrosis. Participants take the medication orally in tablet form for 26 weeks.

Main inclusion criteria: Participants must be at least 40 years old with a diagnosis of progressive fibrotic interstitial lung disease made within the last 5 years. They need a chest HRCT scan performed within the last 24 months, forced vital capacity greater than 45% of expected values, and FEV1/FVC ratio above 0.7 or the lower limit of normal. The lung function must have decreased by at least 5% over the past year based on multiple measurements.

Main exclusion criteria: Patients with lung conditions other than progressive fibrotic interstitial lung disease, those outside the specified age range, vulnerable populations, and those unable to follow study procedures are excluded.

Trial focus: The study evaluates whether senicapoc can slow the decline in lung function over 26 weeks, with the main measure being changes in forced vital capacity. Researchers also monitor quality of life, hospitalizations, and side effects.

Investigational drug: Senicapoc is an ion channel blocker that may help reduce inflammation and fibrosis in lung tissues. It is being studied for its potential to prevent disease progression by blocking specific ion channels at the molecular level.

Study on the Effectiveness and Safety of Rituximab for Patients with Progressive Interstitial Lung Disease with Inflammation

This French trial evaluates rituximab, a medication targeting specific immune system cells, in patients with progressive lung disease that has an inflammatory component. The medication is given through two intravenous infusions.

Main inclusion criteria: Patients must be at least 18 years old with worsening lung disease within the last 24 months, demonstrated by a decrease in forced vital capacity of 10% or more, or a decrease of 5-10% along with worsening breathing symptoms, increased lung disease on HRCT scans, or decreased oxygen transfer capacity. They must also have signs of lung inflammation shown by previous tests. Patients must be covered by French social security and able to follow study requirements.

Main exclusion criteria: People with a history of interstitial lung disease, those outside the specified age range, and vulnerable populations cannot participate.

Trial focus: The study observes changes in lung function, specifically forced vital capacity, over six months comparing rituximab to placebo. Researchers also monitor physical activity levels, respiratory symptoms, quality of life, and any side effects, particularly infections.

Investigational drug: Rituximab is a monoclonal antibody that works by targeting and depleting B-cells, specific immune cells involved in inflammation. It is administered through intravenous infusion with the goal of improving lung function in patients with inflammatory lung disease.

Study on the Effects of Morphine Sulfate for Relieving Breathlessness and Cough in Patients with Fibrotic Interstitial Lung Disease

This Danish trial tests slow-release morphine sulfate tablets to see if they can relieve breathlessness and cough in patients with fibrotic lung disease. The study medications include Malfin, Contalgin, and MST CONTINUS.

Main inclusion criteria: Patients must have fibrotic interstitial lung disease with a GAP score of 2-3, signs of fibrosis on HRCT scans, and an MRC dyspnea score of 3 or higher. They must be at least 18 years old, able to make decisions independently, and provide informed written consent.

Main exclusion criteria: Patients without a diagnosis of fibrotic interstitial lung disease, those outside the specified age range, and those unable to follow study procedures are excluded.

Trial focus: The 4-week study examines how slow-release morphine affects breathlessness in patients with fibrotic lung diseases compared to placebo. Participants report on symptoms and undergo tests like the 6-minute walk test to measure walking distance and oxygen levels.

Investigational drug: Morphine is an opioid analgesic that binds to opioid receptors in the brain to reduce the perception of breathlessness and discomfort. This slow-release form provides prolonged relief from symptoms of dyspnea and cough.

Study on the Effects of Wharton’s Jelly Mesenchymal Stem Cells, Pirfenidone, and Nintedanib for Patients with Fibrotic Interstitial Lung Disease

This Polish trial tests a combination of treatments including allogeneic mesenchymal stem cells derived from Wharton’s jelly (given as an injection), along with oral medications Esbriet (pirfenidone) and Ofev (nintedanib).

Main inclusion criteria: Patients must be over 18 years old. For Group I, participants need a diagnosis of idiopathic pulmonary fibrosis based on lung scans or tissue biopsy, with lung function tests showing FVC greater than 40% and DLCO greater than 25% of normal values, and progression in FVC greater than 10% over the past year. For Group II, participants must have a history of severe COVID-19 pneumonia, a negative COVID-19 test at least 4 weeks before joining, and a diagnosis of lung scarring after COVID-19.

Main exclusion criteria: People with other serious health conditions, those who are pregnant or breastfeeding, participants in another trial within 30 days, those with allergic reactions to similar treatments, inability to follow study procedures, history of drug or alcohol abuse, unstable medical conditions, organ transplant recipients, active infections, and history of cancer within 5 years (except certain skin cancers) are excluded.

Trial focus: The study evaluates the safety and effectiveness of these treatments in managing fibrotic lung diseases, monitoring the number and severity of side effects, changes in lung function, quality of life, and overall survival. The trial continues until March 2025.

Investigational drugs: Wharton’s Jelly Mesenchymal Stem Cells are special cells derived from the umbilical cord that may help repair lung tissue. Pirfenidone and nintedanib are oral medications that help suppress the immune system and slow the progression of lung scarring.

Study on the Use of Hyperpolarized Xenon (129Xe) and Gadobutrol for Imaging in Patients with Progressive Fibrosing Interstitial Lung Diseases

This Danish trial uses special imaging techniques including hyperpolarized 129-xenon MRI to study progressive fibrosing lung diseases. Participants inhale xenon gas and receive an injection of Gadovist contrast agent to help create detailed lung images.

Main inclusion criteria: Patients must be diagnosed with idiopathic pulmonary fibrosis or fibrotic interstitial lung disease meeting criteria for progressive pulmonary fibrosis, be prescribed antifibrotic treatment, be between 18 and 90 years old, and be able to understand and participate in the study. Pre-menopausal women must have a negative pregnancy test.

Main exclusion criteria: People with other serious health conditions, those who are pregnant or breastfeeding, participants in another trial within 30 days, those unable to follow study procedures, people with known allergies to study medications, history of drug or alcohol abuse within the past year, unstable heart disease, severe liver or kidney disease, active cancer or undergoing cancer treatment, and infections requiring antibiotics are excluded.

Trial focus: The study aims to see if these imaging techniques can help identify early signs of lung scarring and monitor changes over time. Researchers evaluate lung function and heart health to track disease progression and treatment response.

Investigational drugs: Hyperpolarized 129-xenon MRI is a non-invasive imaging technique that uses specially prepared xenon gas to create clear pictures of the lungs. Gadobutrol is a contrast agent injected into the body to enhance imaging quality.

Study of Rituximab versus Placebo to Improve Lung Function in Patients with Granulomatous Lymphocytic Interstitial Lung Disease (GLILD)

This trial in Denmark, Norway, Finland, and Sweden evaluates rituximab for improving lung function in patients with GLILD, a rare lung condition affecting the immune system. The medication is given through intravenous infusion.

Main inclusion criteria: Participants must be between 18 and 70 years old with body weight between 50 and 130 kilograms. They need confirmed diagnoses of Common Variable Immunodeficiency (CVID) and GLILD by a team of specialists. Disease progression must be shown by decreased lung function with worsening chest scans, or lung function between specific ranges. Women of childbearing age must use reliable birth control during the study and for 12 months after treatment.

Main exclusion criteria: People under 18 or over 65, those who received rituximab in the past 12 months, those with active infections (hepatitis B, hepatitis C, HIV, tuberculosis), history of severe allergic reactions to biological medications, serious medical conditions, pregnancy or breastfeeding, participation in other trials, inability to perform lung function tests, cancer history in the past 5 years (except treated skin cancer), severe heart, liver or kidney disease, and mental conditions affecting consent are excluded.

Trial focus: The study evaluates changes in lung diffusion capacity over 78 weeks, with assessments at weeks 13, 27, 53, and 78. The trial also monitors health questionnaires, chest scans, and blood samples throughout the treatment period.

Investigational drug: Rituximab is a monoclonal antibody that targets and eliminates B-cells carrying the CD20 protein, effectively reducing inflammation and immune system activity in this rare lung condition.

Study on the Effects of High-Flow Oxygen Therapy in Patients with Interstitial Lung Disease During Exercise

This Spanish trial compares conventional oxygen therapy using a nasal cannula with high-flow oxygen systems during exercise rehabilitation for patients with diffuse interstitial lung disease.

Main inclusion criteria: Participants must be over 30 years old with a diagnosis of interstitial lung disease according to national and international guidelines. They must have signed an informed consent form.

Main exclusion criteria: Patients with a history of interstitial lung disease, those outside the specified age range, vulnerable populations, and those not meeting specific health criteria cannot participate.

Trial focus: The study explores whether high-flow oxygen can better maintain oxygen levels during muscle training exercises compared to conventional oxygen therapy. Researchers also assess how breathlessness affects daily activities, exercise capacity measured by the 6-minute walk test, and overall quality of life.

Investigational drugs: Conventional oxygen therapy provides extra oxygen through a nasal cannula to help patients breathe more easily during physical activities. High-flow oxygen therapy uses a special machine to deliver warm, humidified oxygen at higher flow rates, potentially providing more comfort and better oxygen maintenance during exercise.

Study to Test if Nerandomilast (BI 1015550) Helps Patients with Interstitial Lung Disease Related to Rheumatic Diseases

This multi-country trial (Germany, Netherlands, Austria, France, Spain, Italy, Norway) tests nerandomilast in patients with systemic autoimmune rheumatic diseases associated with lung disease. The medication is taken orally as a film-coated tablet for 26 weeks.

Main inclusion criteria: Participants must have systemic autoimmune rheumatic diseases associated with interstitial lung disease, diagnosed by a rheumatologist with conditions including rheumatoid arthritis, systemic sclerosis (without anticentromere antibodies), idiopathic inflammatory myopathy, Sjögren’s disease, or mixed connective tissue disease. They must have fibrotic lung disease visible on HRCT scans and not have shown improvement despite immune-suppressing therapy. Lung function must show forced vital capacity at least 45% and diffusing capacity at least 25% of normal. Participants must have been on stable immune-suppressing medication for specified periods.

Main exclusion criteria: People with other serious health conditions, recent infections requiring antibiotics, cancer diagnosis in past 5 years (except certain skin cancers), pregnancy or breastfeeding, drug or alcohol abuse in past year, participation in another trial, recent major surgery, known allergies to study medication, and conditions affecting ability to follow instructions are excluded.

Trial focus: The study evaluates the effectiveness and safety of nerandomilast over 26 weeks, monitoring changes in lung health using HRCT imaging and tracking symptoms such as cough and shortness of breath. The trial aims to determine if nerandomilast can improve lung function and quality of life.

Investigational drugs: Nerandomilast is an anti-inflammatory agent that works by modulating inflammatory pathways contributing to lung tissue damage. Nintedanib is another medication used in the trial that helps slow the worsening of lung function in certain conditions.

Summary

These 13 ongoing clinical trials reflect a diverse approach to treating interstitial lung disease across Europe. The trials are notably concentrated in Denmark, Germany, and France, with significant representation in the Netherlands, Spain, and Italy. Several trials span multiple countries, indicating international collaboration in research efforts.

The studies test various therapeutic approaches including immunosuppressants (rituximab, cyclophosphamide, azathioprine, tacrolimus), anti-fibrotic medications (pirfenidone, nintedanib, nerandomilast, senicapoc, tezepelumab), innovative stem cell therapy, symptom management with morphine, and oxygen delivery systems. Several trials focus on BI 1015550 (nerandomilast) across different patient populations, suggesting strong research interest in this particular compound.

The trials address various forms of the disease, from autoimmune-related lung conditions to idiopathic pulmonary fibrosis and progressive fibrosing interstitial lung diseases. Study durations range from 4 weeks to over a year, with most trials monitoring participants for 26 to 78 weeks. These studies aim to improve lung function, slow disease progression, reduce symptoms like breathlessness and cough, and enhance quality of life for patients living with these challenging conditions.

Ongoing Clinical Trials on Interstitial lung disease

  • Study on the Use of Hyperpolarized Xenon (129Xe) and Gadobutrol for Imaging in Patients with Progressive Fibrosing Interstitial Lung Diseases

    Not recruiting

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    Investigated diseases:
    Investigated drugs:
    Denmark

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