Ipf clinical trials




















Environmental factors can cause damage to the tissues between air sacs in the lungs, eventually leading to pulmonary fibrosis. The disease is more common in people in mining, farming, and construction. Pulmonary fibrosis clinical trials have grown in number in recent years. New clinical resources for pulmonary fibrosis are often offered to patients on a trial basis to determine their efficacy. Pulmonary fibrosis evaluation begins with a standard exam. Imaging tests including x-ray, CT scans, and echocardiogram can be used to look at the lungs and heart.

One of the most common is pulmonary function testing. This may include spiormetry, which measures lung capacity when a patient exhales forcefully, or an exercise stress test measuring lung function while jogging on a treadmill.

No medication can reverse the lung damage associated with pulmonary fibrosis. While future treatments may prove effective in stopping the course of the disease, none are available yet.

Pirfenidone and nintedanib are two recent medications being prescribed to slow the progress of idiopathic pulmonary fibrosis. Several other formulations are working through FDA approval. Medication can ease symptoms of disorders that frequently appear alongside pulmonary fibrosis, such as GERD. Oxygen therapy and pulmonary rehabilitation are other options that strengthen and maintain lung capacity.

The signs and symptoms of IPF develop over time. Symptoms may be different between people and may develop slowly or quickly.

Your doctor will diagnose IPF based on your symptoms , your medical and family history, your risk factors , and the results from tests and procedures. Idiopathic means that your doctors cannot determine a cause of your disease at the time of diagnosis. They will rule out other medical reasons or conditions that may be causing your symptoms before diagnosing you with IPF.

This may be done by doing other tests and talking to specialists. To help determine whether you have IPF and rule out other possible causes of lung problems, your doctor may ask about your medical history and possible risk factors. Your doctor may look for signs of IPF during a physical exam, such as:. Your doctor may perform some tests and procedures to help rule out other conditions that may cause lung disorders, including the following:.

There is currently no cure for IPF. Your doctor may recommend medicines, pulmonary rehabilitation , procedures, or other treatments to slow the progression of IPF and help improve your quality of life. A lung transplant may be an option for some people who have advanced IPF. The major complications of a lung transplant are infection and rejection of the new organ by the body. You will have to take medicines for the rest of your life to reduce the risk of rejection following a lung transplant.

If you have been diagnosed with IPF, it is important to continue your treatment plan. Talk to your doctor about how often to schedule follow-up care and how to monitor and understand your condition so you know when to get medical help.

Your doctor may also recommend lifestyle changes and pulmonary rehabilitation to help you manage the disease. It is important to know that the progression of IPF is different for each person and cannot be predicted. Managing your condition is best done with the help of a healthcare team that can help improve your quality of life. Regular checkups with your doctor may be part of your follow-up and treatment. Tell your doctor if you suddenly experience a worsening of symptoms over a period of days or weeks.

This event is called an exacerbation. Sometimes a trigger or other factor may trigger it, but often there is no obvious cause. People who have an exacerbation from IPF may have repeat episodes.

If your condition worsens, you may benefit from oxygen therapy full time. Some people who have IPF carry portable oxygen when they go out. Return to Treatment to review possible treatment options for IPF.

Patients who have IPF can have other conditions as well, so it may be necessary to see multiple doctors who specialize in different areas of medical care. Your doctor may use the following tests and procedures to monitor your condition, and also to determine whether to recommend a lung transplant. Your doctor may recommend that you adopt healthy lifestyle changes to increase your overall health and prevent other conditions.

This includes:. Living with IPF may cause fear, anxiety, depression, and stress. Talking about how you feel with your healthcare team may help. Your doctor may recommend:. To prevent exacerbations, your doctor may recommend avoiding situations where breathing is more difficult, such as in high altitudes, or when the air quality outside is poor from dust or pollution. Your doctor may treat exacerbations with medicines, such as glucocorticoids , or increased levels of supplemental oxygen.

Return to Signs, Symptoms, and Complications to review complications. We are committed to advancing science and translating discoveries into clinical practice to promote the prevention and treatment of heart, lung, blood, and sleep disorders including IPF. Learn about current and future NHLBI efforts to improve health through research and scientific discovery. Learn about the following ways the NHLBI continues to translate current research into improved health for people with idiopathic pulmonary fibrosis.

Learn about some of the pioneering research contributions we have made over the years that have improved clinical care. In support of our mission , we are committed to advancing IPF research, in part through the following ways. We lead or sponsor many studies on idiopathic pulmonary fibrosis IPF.

See if you or someone you know is eligible to participate in our clinical trials. Learn more about participating in a clinical trial. View all trials from ClinicalTrials. After reading our Idiopathic Pulmonary Fibrosis Health Topic, you may be interested in additional information found in the following resources. Idiopathic Pulmonary Fibrosis Idiopathic pulmonary fibrosis IPF is a serious chronic disease that affects the tissue surrounding the air sacs, or alveoli, in your lungs.

This condition occurs when that lung tissue becomes thick and stiff for unknown reasons. Over time, these changes can cause permanent scarring in the lungs, called fibrosis, that make it progressively more difficult to breathe. The most common symptoms of IPF are shortness of breath and cough. Some people may not have symptoms at first, but signs and symptoms can develop and get worse as the disease progresses.

The way IPF advances varies from person to person, and scarring may happen slowly or quickly. In some people, the disease stays the same for years. In other people, the condition rapidly declines. Many people with IPF also experience what are known as acute exacerbations, where symptoms suddenly become much more severe.

Other complications of IPF include pulmonary hypertension and respiratory failure, which happens when the lungs cannot deliver enough oxygen into the bloodstream without support.

This prevents the brain and other organs from getting the oxygen they need. However, certain medicines may slow the progression of IPF, which may extend the lifespan and improve the quality of life for people who have the disease.

Explore this Health Topic to learn more about IPF, our role in research and clinical trials to improve health, and where to find more information. Causes - Idiopathic Pulmonary Fibrosis. Figure A shows the location of the lungs and airways in the body. The inset image shows a detailed view of the lung's airways and air sacs in cross-section.

Figure B shows fibrosis, or scarring, in the lungs. The inset image shows a detailed view of the fibrosis and how it changes the structure around the air sacs.

Look for. Risk Factors will discuss family history, lifestyle, or other environmental factors that increase your risk of developing IPF. Treatment will discuss medicines, procedures, and lifestyle changes that your doctors may recommend if you are diagnosed with IPF. Research for Your Health will discuss how we are using current research and advancing research to better understand and treat IPF.

Risk Factors - Idiopathic Pulmonary Fibrosis. Family history and genetics. Your genes can put you at risk for IPF in a few ways. Read more. Read less. Lifestyle habits. Smoking is a common risk factor among people who have IPF.

IPF is more common among men than women. Screening and Prevention - Idiopathic Pulmonary Fibrosis. Diagnosis will explain the questions, tests, and procedures that your doctor may use to diagnose IPF.

Living With will discuss what your doctor may recommend to prevent your IPF getting worse or leading to complications. Signs and symptoms. The most common signs and symptoms are: Shortness of breath that gets worse over time. At first, you may be short of breath only during exercise.

Over time, you may feel breathless even at rest. There will be a total of 17 infusions over 48 weeks. Participants will not know if they are in the active or placebo group. The investigators will have participants do FVC and FEV1 tests at the start of the study and at the end to determine if pamrevlumab is effective at improving lung function compared with placebo. In the open-label period, they will receive pamrevlumab by IV every 3 weeks, no matter which group they were in during the initial study.

The open-label period could last 48 weeks or longer. The ending time of the open-label period depends on whether the medication is approved or not approved by the FDA. The phase 3 study is based on encouraging data from a recent phase 2 trial that was done to test pamrevlumab versus placebo for patients with IPF.

Treatment occurred over 45 weeks for a total of 16 infusions. Lung function was measured by percent predicted FVC at the beginning of the study and at weeks 12, 24, 36, and At week 48, the average decrease in the percent predicted FVC was 2. This suggests that pamrevlumab treatment slowed the decline in lung function over 48 weeks by This means that pamrevlumab treatment lowers the risk of a rapid worsening in lung disease, or death.

The study also checked lung fibrosis scarring at weeks 24 and 48 using an imaging technique called quantitative high-resolution computed tomography qHRCT. On qHRCT, the average amount of fibrosis that could be seen in the lungs of the patients in the pamrevlumab group increased by In contrast, the average amount of fibrosis in the placebo group increased by This finding suggests that pamrevlumab treatment slowed the accumulation of fibrotic scar tissue over 48 weeks.

The most common side effects were cough, fatigue, breathlessness, upper respiratory tract infection, bronchitis, and headache.

Three patients on pamrevlumab and seven patients on placebo stopped participating the study because of side effects. These two medications show promise for the treatment of IPF. However, it is not completely sure that phase 3 trials will show that they are safe and effective. Not all medications that seem promising in phase 2 trials are actually effective and safe in phase 3 trials.

Not all medications that are tested in phase 3 trials become approved for use. It will be several years before the results of the phase 3 trials are available. Other possible medications are also being developed for IPF.

These are in phase 1 and phase 2 trials now. Some patients with IPF are interested in enrolling in clinical trials. If you are interested, you can talk to your doctor about whether that is appropriate for you.



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