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98 active trials for Idiopathic Pulmonary Fibrosis

JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

A phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

Start: June 2018

A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Start: June 2021

Health-related Quality of Life and Comorbidities in Danish Patients With Idiopathic Pulmonary Fibrosis - a Nationwide Follow-up

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease with a high mortality. Health-related quality of life (HRQL) is impaired in patients with IPF. Little is known about the properties of recently developed HRQL questionnaires and about the longitudinal changes in HRQL, including factors with an impact on HRQL. Comorbidities have an impact on patients with IPF, but reports differ in incidence and prevalence. The impact of comorbidities on HRQL and disease progression has only been studied sparsely. Also, the association between biomarkers and disease progression need to be examined further.

Start: August 2016

Early Diagnosis of Pulmonary Fibrosis - Diagnostic Delay

Patients with newly diagnosed IPF are investigated for the diagnostic delay before a diagnosis of IPF is made.

Start: March 2016

Impulse Oscillometry for Prognostication in Idiopathic Pulmonary Fibrosis

A 5-point decline of forced vital capacity expressed as % predicted, over 6 months, is the current definition of disease progression (fast decline in lung function) in idiopathic pulmonary fibrosis. There is a need for techniques allowing to characterize disease progression earlier, so that treatment may be adapted as early as possible in the lack of a response. Hypothesis. Our hypothesis is that 3-month changes of lung function parameters measured by a novel technique, impulse oscillometry, predicts 6-month changes in forced vital capacity in idiopathic pulmonary fibrosis.

Start: April 2019

129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study

This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a non-invasive biomarker of disease severity and prognosis. The study will include approximately 15 subjects with IPF, 15 subjects with cHP and 10 sex and age-matched normal controls performed across 3 sites.

Start: June 2021

Investigating Idiopathic Pulmonary Fibrosis in Greece (INDULGE IPF)

To gain further insight on the characteristics, management, disease progression and the outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice conditions in Greece. More specifically, this registry will be used to: Provide a comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF patients over time, Examine the implementation of treatment guidelines used on patients diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of patients on different treatments. To provide information regarding survival and mortality causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis, hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF patient hospitalization will be collected and evaluated with regards to potential respiratory causes, and there will be documentation of treatment patterns and economic aspects. Patients will be followed up for 2 years and information regarding IPF treatment changes since the last visit will be collected.

Start: April 2017

Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough

NP-120 (Ifenprodil) has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of Idiopathic Pulmonary Fibrosis (IPF). In addition, NP-120 significantly reduced both cough frequency and onset in a guinea pig tussive model. The purpose of this proof-of-concept trial is to determine the efficacy of NP-120 in the treatment of IPF and its associated cough.

Start: July 2020

IPF mHealth Exercise

Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments.

Start: April 2021

The NIH Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients With Interstitial Lung Disease

Interstitial lung disease (ILD) is the result of over 200 etiological pathways arising from several different insults to the lung parenchyma: inhaled substances, drug side effects, connective tissue disease, infection, and malignancy. The disease can also be of idiopathic origin. If prolonged, the resulting inflammation causes permanent and progressive fibrotic reorganization of the parenchyma and small airways, which reduces the distensibility of the lung and impedes O2 and CO2 exchange. This study is a randomized controlled trial to determine the safety and efficacy of aerobic exercise for patients who have interstitial lung disease (ILD) uncomplicated by pulmonary hypertension. In an uncontrolled study, we observed more efficient cardiorespiratory function, increased physical work capacity, and improved health-related quality of life following aerobic exercise in this study population. Serious adverse events resulting from aerobic exercise training were not observed and our work to date has established plausibility for the efficacy of aerobic exercise training and its safety for patients with ILD.

Start: May 2015

A Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Idiopathic Pulmonary Fibrosis

This is a Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, pharmacokinetics (PK), quality of life and exploratory pharmacodynamics (PD) of two treatment doses of CC-90001, 200 mg and 400 mg, compared with placebo, when delivered once daily per os (PO) in subjects with idiopathic pulmonary fibrosis (IPF). This study is designed to assess response to treatment by using measures of lung function, disease progression, fibrosis on radiography, and patient-reported outcomes. It will also assess dose response.

Start: July 2017

Safety, Efficacy and Pharmacokinetics of C21 in Subjects With IPF

This trial is a multi-centre, open-label, single-arm phase 2 trial investigating the safety, efficacy and pharmacokinetics of C21 in subjects with idiopathic pulmonary fibrosis.

Start: November 2020

Nutritional Assessment in Idiopathic Pulmonary Fibrosis

In recent years nutritional status assumed increasing importance in the evaluation of chronic respiratory diseases, considering that their clinical course is often characterized by a progressive loss of weight and reduction of muscle mass.In regards to Idiopathic Pulmonary Fibrosis (IPF), to date there are no studies that fully assessed the nutritional status of patients, nor the impact of the introduction of specific anti-fibrotic agents on the nutritional status of these patients. Aim of this study is to assess the nutritional status of patients with IPF at the time of diagnosis and the impact of the introduction of specific anti-fibrotic agents, pirfenidone or nintedanib, on the nutritional status itself.

Start: December 2018

Cardiovascular Fibrosis in Idiopathic Pulmonary Fibrosis

Fibroproliferative diseases, including pulmonary, cardiac and vascular fibrosis share common pathogenetic mechanisms. Furthermore, cardiovascular comorbidities are frequently found in patients with IPF. However, the prevalence of cardiac and vascular fibrosis in patients with IPF have yet to be determined. Main Purpose of this study is to evaluate, with non-invasive methods (echocardiogram, endothelial function and pulse wave velocity) and blood biomarkers (galectins-3, osteopontin, periostin and pro-BNP), the presence of vascular fibrosis (vascular rigidity and endothelial function) and cardiac fibrosis (prevalence of HFpEF - Heart Failure with Preserved Ejection Fraction) in patients with idiopathic pulmonary fibrosis (IPF), compared to healthy controls.

Start: October 2019

Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.

Start: March 2019

Mechanisms of Familial Pulmonary Fibrosis

This a prospective, longitudinal study of first-degree family members of patients diagnosed with familial interstitial pneumonia (FIP). FIP is the familial form of idiopathic pulmonary fibrosis (IPF), which is defined as 2 or more bloodline relatives which have a diagnosis of idiopathic interstitial pneumonia (IIP). The most common form of idiopathic interstitial pneumonia in FIP families is IPF (approximately 70%). The inheritance pattern in FIP is consistent with autosomal dominant inheritance with incomplete penetrance. Therefore, individuals in this study have approximately 50% risk of carrying a disease-associated allele. The causative gene is currently only known approximately 20% of families. The main goal of this longitudinal study is to better establish the natural history of FIP and to identify risk factors for later development of symptomatic disease. The investigators' plan is to follow these at-risk individuals with yearly questionnaires and planned in person 5 year follow-ups through age 70 or until they develop symptomatic FIP.

Start: January 2009

Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 with [18F]FP-R01-MG-F2 with PET/CT

Start: November 2017

Changes in iOS in IPF

Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities. Lung function tests are breathing tests that measure how well your lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately. This might unfairly lead to some people with IPF not receiving the right medications or for their medications to be stopped too soon. Impulse oscillometry (iOS) uses sound waves to measure the stiffness of the lung, and has been used successfully in children who are unable to perform normal lung function tests. The overall aim of the research is to see whether changes in iOS measures can give useful information about the lungs in patients with IPF; for example, by judging the overall impact of the disease on the lungs, or predicting future deterioration. We will look at how iOS changes over time in patients with IPF, and to see whether these measurements can tell us about whether IPF is getting worse or predict important health events, such as hospital admission. We will compare change in iOS with changes in other tests used to monitor IPF and with patient reported ratings of change in their condition. This will help decide the amount of iOS change that is noticed and considered meaningful by people with IPF.

Start: November 2020

Reliability and Validity of iOS in IPF

Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities. Lung function tests are breathing tests that measure how well the lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately. Impulse oscillometry (iOS) is a new type of breathing test. It uses sound waves to measure the stiffness of the lung. The test is very quick (30 seconds), does not require any effort from the patient, and only requires a patient to breathe in their usual way. iOS has been used successfully in children who are unable to perform normal lung function tests. The investigators will assess whether people with IPF can perform iOS tests accurately and to compare their experiences of having iOS tests with their experience of performing current lung function tests. The investigators will also compare whether there is a relationship between iOS tests and the information gathered from the tests currently used by doctors to measure the impact of IPF (lung function tests, exercise tests, lung scans and questionnaires that measure quality of life).

Start: November 2020

High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

Objectives: To evaluate endurance time during cardiopulmonary exercise test (CPET) performance comparing standard oxygen therapy to high-flow nasal cannula (HFNC) oxygen therapy in subjects with idiopathic pulmonary fibrosis (IPF) with exertional desaturation. To assess oxygenation level as well as dyspnea and fatigue during exercise in IPF subjects with exertional desaturation using oxygen supplementation with HFNC compared with standard oxygen supplementation. Method: multicenter crossover clinical trial. Patients with IPF presenting oxygen desaturation during the six-minute walking test (6MWT) (SpO2 mean ? 85%) will be included consecutively . Each subject evaluated will perform initially an incremental CPET to evaluate the patient's maximum exercise capacity. Supplemental oxygen will be applied to maintain SpO2 >85% with a Venturi mask. Maximum exercise capacity and the appropriate final oxygen inspiratory fraction (FiO2) needed for the following tests will be determined. Posteriorly each patient will perform two constant load CPET (at 75% of the maximum workload achieved with the incremental CPET); one with standard oxygen therapy and the other one with HFNC oxygen therapy. Endurance time, dyspnea and leg fatigue and oxygen saturation will be recorded. Evaluation measures: Endurance time, dyspnea and leg fatigue (Borg scale), and oxygen saturation.

Start: March 2019