Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary...
Idiopathic Pulmonary FibrosisPulmonary Disease1 moreIdiopathic Pulmonary Fibrosis(IPF) is the most common idiopathic interstitial lung disease whose cause is unknown. With age and gender, socio-economic factors are the most influential indicators of health. At present there is very little data on socio-economic factors in the IPF. The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF. The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.
Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric...
Vitamin D DeficiencyCystic Fibrosis5 moreCystic fibrosis (CF) is an autosomal recessive disease caused by alterations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene, characterized by multisystemic alterations, mainly in the lung, intestine, sweat, and bile ducts. In addition to pulmonary involvement, the presence of exocrine pancreatic insufficiency also increases the risk of survival, as it is associated with malnutrition and deficiency of fat-soluble vitamins, such as vitamin D. Vitamin D, in addition to its role in bone health, in the case of CF patients with chronic inflammation, it has been suggested that many of the cytokines that regulate the inflammatory response contain elements that respond to vitamin D, so vitamin D could play an essential role in the regulation of the inflammatory response in CF, which could favor lung function. However, more than 50% of CF patients present vitamin D insufficiency or deficiency, despite the different schemes suggested for supplementation in different age groups, which suggests that new strategies are needed to normalize vitamin D levels, which will allow us to see its clinical effect on the inflammatory response, by decreasing the number of exacerbations and thus perpetuating or improving lung function, as well as on bone mineral health.
A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients
Idiopathic Pulmonary FibrosisThis study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.
Evolution of Lung 18FDG Uptake in Patients With Idiopathic Pulmonary Fibrosis and Receiving Pirfenidone...
Idiopathic Pulmonary FibrosisIdiopathic pulmonary fibrosis (IPF) is a rare and fatal lung disease characterized by unpredictable changes with variable kinetics of progression. Changes in pulmonary function (FVC, DLCO) assessed at the time of diagnosis, or decline in pulmonary function within 12 months after diagnosis, are the best predictors of survival, but poorly predicted disease activity and evolution. 18FDG positron emission tomography (18FDG PETscan) provides the ability to quantify cell metabolism in vivo and non-invasively using a labeled non-metabolizable substrate. Several parameters can be measured in an automated and reproducible way, such as the mean fixation intensity (SUV mean), the maximum fixation intensity (SUV max), the hyperfixing volume measurement (MLV) or the glycolytic activity measurement tissue or TLG (total lesions glycolysis). Several studies have demonstrated an increase of glycolytic activity in lung fibroblast from IPF patient. In a recent study, the investigators demonstrated a strong correlation between the lung uptake parameters and the lung function tests results (LFTs) and prognostic score GAP. In addition, MLV and TLG were factors prognostic and independently associated with progression-free survival at 12 months. In a preliminary study, the investigators studied the change of these parameters in twelve patients treated with pirfenidone for IPF who performed an 18FDG PETscan before the initiation of treatment and about twelve weeks later. A mean decrease of 30% in TLG value between the two evaluations was observed. These preliminary data suggest that pirfenidone influences lung metabolism in patients with IPF. The investigators aim to conduct a prospective study to confirm and refine the preliminary data.
First-in-human Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of C106 in Healthy...
Safety IssuesTolerance2 moreThis is a FIH, double-blind, placebo-controlled, within-group randomised, trial designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending oral doses of compound 106 (C106) in healthy females of non-childbearing potential and healthy males. The trial will be conducted in 2 parts: Part A, single ascending dose (SAD) including a food interaction cohort: safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving single ascending doses of C106. Part B, multiple ascending dose (MAD): safety, tolerability, and PK in healthy males and healthy females of non-childbearing potential receiving twice daily multiple ascending doses of C106 for 8 days.
Evaluation of Oral ORIN1001 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary FibrosisThis Phase 1b trial is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of oral ORIN1001 at 25 mg, 50 mg or 100 mg administered daily for up to 28 days in adult subjects with idiopathic pulmonary fibrosis (IPF) alone or in conjunction with local Standard of Care for IPF (pirfenidone or nintedanib). A maximum of 24 evaluable subjects will be required to complete the study. The study will consist of 3 dose cohorts each enrolling a maximum of 8 subjects randomized either to the active (5 subjects) group or placebo (3 subjects) group. Each subject will receive daily oral doses of ORIN1001 or placebo for 28 days. The safety and pharmacokinetic profile will be evaluated in this study and will include cardiovascular and pulmonary endpoints.
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary...
Idiopathic Pulmonary FibrosisThis is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
Pirfenidone vs. Nintedanib for Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia
Novel Coronavirus-induced Lung FibrosisThe antifibrotic agents, namely pirfenidone and nintedanib have been found to be effective in the treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib has also been found to be effective in treating systemic sclerosis-related interstitial lung disease (ILD) and non-IPF progressive fibrosing ILDs. Pirfenidone has also been found beneficial unclassifiable ILDs. Whether these drugs would be effective in treating post-COVID lung fibrosis also is unknown. As the final pathway of lung fibrosis appears to be common among different diffuse parenchymal lung diseases (DPLDs), it is hoped that these antifibrotic agents might be helpful in post-COVID fibrosis. There are no randomized studies that have assessed the role of pirfenidone or nintedanib in post COVID fibrosis. In the current study, we aim to assess the efficacy and safety of pirfenidone and compare it with nintedanib in the treatment of post-COVID lung fibrosis.
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary...
Idiopathic Pulmonary FibrosisThis study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary FibrosisThis is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).