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Lung Diseases, Interstitial clinical trials

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NCT ID: NCT05129410 Recruiting - Clinical trials for Interstitial Lung Disease

Clinical Study of MMF in Treatment of IIM-ILD and Its Effect on Peripheral Blood Treg Cells

Start date: December 1, 2020
Phase: Phase 4
Study type: Interventional

Interstitial lung disease (ILD) is a common pulmonary manifestation of idiopathic inflammatory myopathy (IIM). The overall 5-year mortality is 50%. The prognosis is poor and the treatment is challenging.At present, according to the consensus of IIM-ILD experts, glucocorticoids as first-line treatment are often used in high doses and have a variety of adverse reactions. Previous studies have shown that cyclophosphamide (CYC) is effective for IIM-ILD and tends to be used in rapidly progressive interstitial lung disease(RP-ILD)or refractory ILD. However, CYC is an alkylating agent with many toxic and side effects. It is prone to gonadal inhibition, infection, tumor, hemorrhagic cystitis and other risks. At present, Mycophenolate mofetil (MMF) has been widly used in the treatment of IIM, systemic lupus erythematosus (SLE), ANCA associated vasculitis (AAV). The observational research on MMF in the treatment of IIM-ILD shows that it can delay the progress of pulmonary fibrosis and can be used as the first-line treatment of IIM-ILD. Moreover, immune tolerance caused by defects in the number and/or quality of regulatory T cells (Treg) is considered to be a key source of autoimmune diseases. However, it is unclear whether MMF can improve the immune status of IIM-ILD by increasing Treg cells. The aim of this study was to evaluate the effect of MMF for IIM-ILD and its effcts on Treg through a prospective open single arm study, and provide a theoretical basis for the individualized treatment of IIM-ILD, which has important clinical significance.

NCT ID: NCT05120934 Recruiting - Clinical trials for Interstitial Lung Disease

Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough

MACS-2
Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

This research study is evaluating the effectiveness of escalating doses of Amitriptyline and Duloxetine in reducing cough frequency in patients with interstitial lung disease (ILD)-related cough.

NCT ID: NCT05007457 Recruiting - Covid19 Clinical Trials

The Effectiveness of Respiratory Tele-rehabilitation After COVID-19 Pneumonia Related: a Randomized Controlled Trial

Start date: June 12, 2021
Phase: N/A
Study type: Interventional

In recent months, more and more studies suggest tele-rehabilitation as a means to be exploited to reduce the risk of contagion. The intent of our study is to verify the effectiveness of a tele-rehabilitation intervention through the application of a respiratory rehabilitation program supported by contact with physiotherapists, in patients with outcomes from SARS-CoV-2 infection discharged from the various medical departments and taken over by physiotherapists after physiatric evaluation. Faced with the same rehabilitation program prescribed to all patients, the primary objective of our study is to detect whether patients supported by remote rehabilitation after hospitalization improve both adherence to the rehabilitation program and cardiorespiratory endurance and dyspnea symptoms assessed with the Six Minute Walking Test scale (6MWT). This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis, the clinic of which could be comparable to the outcomes of coronavirus interstitial pneumonia as suggested by the literature. The secondary objectives concern the assessment of the impact of physical exercise assisted by tele-rehabilitation detected through: the assessment of the quality of life (Saint George Respiratory Questionnaire );the assessment of autonomy in daily life activities (Barthel Index Dyspnea Scale), the evaluation of the variation in thoracic expansion and lung volumes (with COACH , an instrument for respiratory physiotherapy that measures the inspiratory volume in ml); the evaluation of muscle strength and endurance (One Minute Sit To Stand) ; the detection of dyspnea during the execution of the exercises (Modified Borg scale); the assessment of the functionality of the lower limbs (Short Physical Performance Battery)

NCT ID: NCT05007340 Recruiting - Clinical trials for Systemic Lupus Erythematosus

ILD-SARDs Registry and Biorepository

ILD-SARDs
Start date: August 24, 2021
Phase:
Study type: Observational [Patient Registry]

A complex interaction between demographic, environmental and genetic mechanisms impact the onset, severity and outcome of ILD-SARDs through dysregulation of the immune system and lung pro-biotic pathways. Comorbidity and genetic risk indicate that there are overlapping pathogenic mechanisms among SARDs, some of which underlie ILD in different SARDs. The purpose of this biobank is to study the clinical, pathological, laboratory, and imaging characteristics of SARDs patients with lung involvement. This will help identify as unique features underlying lung involvement in SARDs. In addition, this may lead to the discovery of novel mechanisms of disease and potentially novel targets of treatment for SARDs patients with lung disease.

NCT ID: NCT04930666 Recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

BREATHE ALD: A Shared Decision-Making Intervention for Adults With Advanced Lung Disease

BREATHE-ALD
Start date: November 10, 2021
Phase:
Study type: Observational

This study aims to: 1. Develop the BREATHE-ALD intervention for adults with Advanced Lung Disease, multiple chronic conditions, and palliative care needs and their caregivers using interviews with 10 advanced lung disease (ALD) adults and their caregivers 2. To evaluate the feasibility and acceptability of intervention procedures; and 3. To explore intervention effects on ALD outcomes

NCT ID: NCT04925375 Recruiting - Clinical trials for Interstitial Lung Disease

Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease

ABCVILD
Start date: July 14, 2021
Phase: Phase 2
Study type: Interventional

There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID. This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID. Funding Source - FDA OOPD

NCT ID: NCT04855305 Recruiting - Clinical trials for Interstitial Lung Diseases

Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

Start date: November 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).

NCT ID: NCT04807127 Recruiting - Immunotherapy Clinical Trials

A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade

Start date: February 1, 2020
Phase:
Study type: Observational

The main goal of this prospective non-interventional exploratory monocentric study is to characterize the immune cell composition of bronchoalveolar lavage (BAL) fluid from cancer patients experiencing cancer therapy-induced pneumonitis on a single-cell scale. These mechanistic insights can directly lead to putative diagnostic biomarkers and therapeutic targets. A second highly clinically relevant hypothesis is that single-cell profiling of blood samples will reveal circulating biomarkers of ICB toxicity, making non-invasive diagnosis feasible.

NCT ID: NCT04807114 Recruiting - NSCLC Clinical Trials

A Single-cell Approach to Identify Biomarkers of Efficacy and Toxicity for ICI in NSCLC

Start date: February 1, 2020
Phase:
Study type: Observational

The main goal of this prospective non-interventional exploratory study is to characterize the tumor micro-environment of advanced NSCLC in single-cell resolution, prior to immune checkpoint blockade exposure, and correlate the findings to clinical outcome. This approach will allow to generate new hypotheses regarding mechanism of action of ICI and (primary) resistance mechanisms. The long-term goal is that these novel mechanistic insights will be translated to a clinical setting to develop better biomarkers of ICI efficacy. Importantly, since the investigators will also sequentially profile the immune composition of peripheral blood, this research offers an opportunity to develop circulating (non-invasive) biomarkers. A second aim is to characterize the immune cell composition of bronchoalveolar lavage (BAL) fluid from these ICI-treated cancer patients if they would develop ICI-pneumonitis. These mechanistic insights can directly lead to putative diagnostic biomarkers and therpeutic targets. Since single-cell profiling of blood samples will also be performed, circulating biomarkers of ICI toxicity can also be identified, making non-invasive diagnosis feasible.

NCT ID: NCT04805086 Recruiting - Covid19 Clinical Trials

The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19

MONACO
Start date: March 8, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Up to a third of patients who recovered from SARS coronavirus (SARS-CoV) had a 20% decline in lung function with a long term reduction in exercise capacity and SF-36 health status a year after infection. Similar outcomes are now being reported in COVID-19 patients, with interstitial lung disease (fibrosis) and long term lung function decline being a common feature. Anti-fibrotic monocytes/macrophages are important for the clearance of partially degraded collagen fragments of fibrotic extracellular matrix, in particular fibrillary-type collagen. MON002 is an autologous monocyte product, cultured in vitro prior to intravenous delivery into patients with post-COVID-19 lung fibrosis.