Learn about Research & Clinical Trials
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Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease
Assess efficacy (as measured by annual rate of decline in FVC) and safety. The hypothesis is that nintedanib will be safe and effective therapy for patients with progressive fibrosing CMD-ILD over a period of 52 weeks. Test Article - Nintedanib 150 mg administered PO twice daily or matching placebo. A total of 160 patients meeting inclusion/exclusion criteria will be randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily. A randomization scheme will be used that balances the group for potential confounders (proportion with PMF or small opacity-only PF-CMD_ILD and proportion of ever- or ...
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Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease
Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T...
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Evaluation of Patients With Diffuse Parenchymal Lung Diseases Regarding Frailty
There are very few studies in the literature examining the frailty levels of diffuse parenchymal lung disease (DPLD) patients and its effect on their functional status despite the high prevalance of frailty in patients with DPLD This observational study aims to learn about the relationship between frailty and functional capacity and balance in DPLD patients compared to healthy subjects.
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Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease
The aim of this study is to validate the six minute Stepper Test (6MST) and the 5-repetition chair lift test (5STS) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease. As the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6MST and 5STS in comparison with their respective gold standards.
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Exploration of the Predictive Marker and Establishment of Predictive Models of Checkpoint Inhibitor Pneumonitis
This is a prospective, multicenter observational study to explore the predictive factors of checkpoint inhibitor pneumonitis (CIP) and to establish predictive models by combining imaging information for IRP. The imaging type of CIP, the pathological type, various inflammatory cytokines and tumor proportion score(TPS) of PD-L1 expression level, etc. will be paid more attention.
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Faecal Microbiota Transplantation to Ameliorate Nintedanib-induced Diarrhea in Patients With Idiopathic Pulmonary Fibrosis
This is a multicentric, randomised, double-blind, placebo-controlled study that will consist of two consecutive phases: 1. First phase: faecal samples will be collected in patients diagnosed with Idiopathic pulmonary fibrosis treated with nintedanib. 2. Second phase: double-blind, randomised, clinical trial of autologous faecal microbiota transplantation (FMT) vs placebo in Idiopathic pulmonary fibrosis patients who will experience nintedanib-induced diarrhea within 8 weeks of baseline visit. Follow-up visits will be scheduled at 1, 4 and 12 weeks after randomization. The main aim of the study is to...
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H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Background: Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years. Objective: To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis. Eligibility: People aged 18 years and older with interstitial lung disease or lung fibrosis. Design: Participants will have at least 7 clinic visits over 5 months. Participants...
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HR Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of ILD Patients
To establish a simplified approach for assessment of severity of interstitial lung disease by evaluating the relationship between HRCT findings, the clinical severity score,spirometry and quality of life.
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Hydroxychloroquine as a Steroid-sparing Agent in Extrapulmonary Sarcoidosis
Sarcoidosis is a systemic granulomatous disease of unknown aetiology, mainly affecting the lungs and lymphatics. It affects people worldwide (incidence, 4.7-64/100000; prevalence, 1-36/100000/year). Although it is most often a benign acute or subacute condition, sarcoidosis may progress to a disabling chronic disease in 25% of the cases, with severe complications in about 5%, such as lung fibrosis, cardiac or neurosarcoidosis, defacing lupus pernio or blindness due to uveitis. When indicated, corticosteroids (CS) are the mainstay of treatment. Due to the kinetics of granuloma resolution, the usual and quite 'dogmatic' duration of...
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Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes
The aim of this proposed study is to evaluate the efficacy and safety of hydroxychloroquine (HCQ) in children's interstitial lung diseases(chILD) with genetic causes. This study is a randomized controlled clinical trial.