RecruitingRare disease

Study to evaluate the safety and effectiveness of inhaled nintedanib in patients with idiopathic pulmonary fibrosis

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the safety and effectiveness of a treatment for Idiopathic Pulmonary Fibrosis, a condition where the lungs become scarred and thick over time. The research focuses on a medication known as nintedanib, which will be delivered to the lungs using an inhalation solution called AP02. This method involves breathing in the medicine directly into the airways.

Participants in this study will be assigned to receive different amounts of the medication, either AP02 High or AP02 Low, or a placebo. The study aims to determine how these doses affect lung function over a period of 12 weeks. During this time, the way the lungs work will be monitored to see if the treatment helps slow down the progression of the disease.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation and medication administration
Participation in this study involves receiving either an inhalation solution containing nintedanib or a placebo, which is a substance with no active medicine.
If assigned to the high dose group, an 8 mg dose of nintedanib will be taken via inhalation (breathing the medicine into the lungs) twice a day.
If assigned to the low dose group, a 4 mg dose of nintedanib will be taken via inhalation twice a day.
If assigned to the placebo group, the inhalation will be administered twice a day without active medicine.
Step 2
Monitoring and evaluation
The medication administration and monitoring period lasts for 12 weeks.
Lung function is measured through a test called forced vital capacity (FVC), which calculates the amount of air that can be forcefully exhaled, specifically measured in the morning before taking the medication.
The study also evaluates disease progression, which is tracked by looking for a 10% decline in lung capacity, any hospitalization related to breathing, or death.
Imaging via high-resolution computed tomography (HRCT), a detailed type of X-ray, is used to measure changes in lung fibrosis (scarring of the lung tissue) at the end of the 12-week period.

Who can join the trial?

10 criteria

You must be able to understand and sign a written informed consent form, which is a document that explains all the details of the study before you agree to join.
You must be able to follow all the study rules, take the medicine exactly as directed, follow any rules about other medicines you are taking, and attend all scheduled clinic visits.
You must be 40 years of age or older at the start of the study.
You must have had a chest HRCT, which is a special type of detailed X-ray scan that shows the lungs in high resolution, within the last year.
You must have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF), a lung disease, within the last 5 years based on official medical guidelines.
Your diagnosis must be confirmed by a doctor using both the HRCT scan patterns and, if available, results from a surgical lung biopsy, which is a procedure where a small piece of lung tissue is removed to be examined.
Your DLCO, which is a test that measures how well gases move from your lungs into your blood, must be between 30% and 80% of what is considered normal.
Your FVC, which is a measurement of the total amount of air you can breathe out after taking a deep breath, must be at least 45% of the normal expected value.
Men and women who can become pregnant must agree to use highly effective contraception, which are birth control methods with a very low failure rate (less than 1% per year), such as an intrauterine device or specific hormonal methods, starting from the first dose of study medicine until 90 days after the last dose.
Participants must agree not to donate eggs or sperm during the time they are taking the study medicine and for 90 days after the last dose.

Who cannot join the trial?

33 criteria

You are currently taking, or have taken within the last 3 months, oral nintedanib or pirfenidone, which are medications used to treat lung disease.
The doctor believes you will likely need a lung transplant (a surgery to replace damaged lungs with healthy lungs from a donor) within the next year.
You have unstable asthma or chronic obstructive pulmonary disease (COPD), which are conditions that make breathing difficult, especially if you needed oral corticosteroids (steroid medicines taken by mouth) to treat a sudden worsening of symptoms in the last 12 weeks.
You have had an active respiratory tract infection (an infection in your breathing passages, such as the lungs or throat) that requires treatment within the last 4 weeks.
You currently smoke any products, including vaping, or have smoked within the last 12 weeks and cannot stop.
You use illicit drugs or drugs of abuse.
You are pregnant, breastfeeding, or planning to become pregnant during the study.
During testing, you experience bronchospasm (a sudden tightening of the muscles in the airways) or a significant drop in your FEV1 (the amount of air you can forcefully exhale in one second) after breathing in a salt solution.
The doctor finds any other significant abnormalities in your lungs or the pleura (the thin membrane or lining that surrounds the lungs).
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You have certain cardiovascular diseases (heart and blood vessel problems), such as:
- Severe hypertension (extremely high blood pressure) or severe hypotension (extremely low blood pressure) within the last 12 weeks.
- Blood pressure that is not well-controlled.
- A myocardial infarction (heart attack) within the last 24 weeks.
- Unstable angina (chest pain caused by reduced blood flow to the heart) within the last 24 weeks.
- Class IV heart failure (a severe stage of heart disease where the heart cannot pump enough blood to meet the body's needs).
- You have moderate to severe hepatic impairment (liver damage or poor liver function) or end-stage liver disease.
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  You use certain prohibited medications, including:
  - Other approved drugs for your lung disease, unless used for a sudden flare-up.
  - Medicines like azathioprine, cyclophosphamide, or cyclosporine A within the last 8 weeks.
  - High doses of prednisone (a steroid) within the last 2 weeks.
  - Any other investigational therapy (a drug being tested in a study) within the last 30 days.
  - Certain vaccines (for flu, pneumonia, or COVID-19) within the last 2 weeks.
  - You have severe renal impairment (serious kidney problems), defined as a creatinine clearance (a measure of how well your kidneys filter waste) of less than 30 mL/min.
  - You have had malignancy (cancer) within the last 5 years, with some specific skin or cervical exceptions.
  - You have any other medical condition that the doctor believes could make the study unsafe for you or affect the results.
  - You have previously participated in a study for AP01 or AP02.
  - You are participating in another clinical study or have taken an experimental drug within the last 30 days.
  - The doctor determines you are not a suitable candidate or unlikely to follow the study rules.
  - Your laboratory results show high levels of liver enzymes like ALT or AST, or high total bilirubin (a substance produced by the liver).
  - Your lung function tests show a ratio of FEV1/FVC (the amount of air you breathe out quickly compared to the total amount you can breathe out) that is too low.
  - You have a high bleeding risk, such as a genetic tendency to bleed, a need for anticoagulation (blood-thinning medication), or a history of hemoptysis (coughing up blood).
  - You have a high thrombotic risk (risk of blood clots), such as a genetic tendency for clots, a history of stroke or transient ischemic attacks (temporary loss of brain function due to blood flow issues) in the last 12 months, or abnormal coagulation parameters (blood clotting tests).
  - You are at risk for gastrointestinal perforation (a hole in the stomach or intestines), including having recent abdominal surgery, a history of diverticular disease (small pouches in the colon), or taking certain anti-inflammatory medicines.
  - You have experienced hematuria (blood in the urine), active gastrointestinal bleeding (bleeding in the stomach or intestines), or major injuries/surgeries in the last 12 weeks.
  - Your life expectancy due to any existing health conditions is estimated to be less than 1 year.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
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Hospital Universitario Hm Sanchinarro
Madrid, Spain

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Investigated drugs

Nintedanib is an inhaled solution used to treat people with idiopathic pulmonary fibrosis, a condition that causes scarring in the lungs. In this study, it is being tested to see how well it helps maintain lung function when breathed in through an inhaler.

What is already known about the treatment

Nintedanib - This medication is an inhaled liquid solution used to treat lung scarring diseases like idiopathic pulmonary fibrosis. It is currently an established treatment in medical practice and works by blocking specific proteins that tell the body to build excessive scar tissue in the lungs. Classified as a tyrosine kinase inhibitor, it helps slow down the progression of the disease at a molecular level by stopping the signals that cause lung cells to multiply uncontrollably.

Investigated diseases

Idiopathic Pulmonary Fibrosis - This is a condition where the lung tissue becomes thick, stiff, and scarred over time. The exact cause of this scarring is unknown. As the disease progresses, the thickening of the tissue makes it increasingly difficult for the lungs to expand and contract. This process gradually reduces the amount of oxygen that can enter the bloodstream. The scarring typically occurs within the lungs and worsens continuously.