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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: NCT05128929 Completed - Clinical trials for Pulmonary Hypertension

Investigation of H01 in Adults With Pulmonary Hypertension Including Interstitial Lung Disease (The SATURN Study).

SATURN
Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

This study is a prospective, randomized, double-blind, study of H01 (Hymecromone) in adults with pulmonary hypertension (PH). The primary objective of this study is to evaluate the safety and tolerability of oral H01 and the potential benefit of oral H01 on clinical measures of PH disease severity over 24 weeks. Study Hypothesis: Oral H01, at doses of 1600 mg per day, will be a safe and well-tolerated agent in adults with pulmonary hypertension over 24 weeks

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: NCT05106556 Active, not recruiting - Clinical trials for Interstitial Lung Disease

Effect of Respiratory Muscle Training in Interstitial Lung Patients

Start date: December 9, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the possible effects of inspiratory muscle training (IMT) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease.

NCT ID: NCT05095363 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Palliative Care Planner (PCplanner)

Start date: March 16, 2022
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.

NCT ID: NCT05079126 Terminated - Clinical trials for Interstitial Lung Disease

Study of Trans Sodium Crocetinate in Patients With Interstitial Lung Disease

ILD-DLCO
Start date: December 2, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, placebo-controlled study of Trans Sodium Crocetinate (TSC) in patients with Interstitial Lung Disease (ILD), age 30-85 (inclusive). The primary objective of the study is to determine the effect of TSC on lung function as measured by diffusing capacity of the lungs for carbon monoxide (DLCO) in patients with ILD; the secondary objectives are to determine the effect of TSC on the 6-minute walk test (6MWT), heart rate recovery (HRR), and Borg Scale in patients with ILD.

NCT ID: NCT05068869 Active, not recruiting - Cancer Clinical Trials

Digital Outpatient Services

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

More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase. The aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes. The current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers.

NCT ID: NCT05067517 Not yet recruiting - Clinical trials for Progressive Fibrosing Interstitial Lung Disease

Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease

Start date: November 2021
Phase: Phase 3
Study type: Interventional

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 never-smokers). The dose of the study drug may be reduced to 100 mg twice daily or interrupted temporarily to manage adverse events (AEs).

NCT ID: NCT05065190 Completed - Clinical trials for Lung Diseases, Interstitial

A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis

Start date: November 25, 2021
Phase: Phase 3
Study type: Interventional

This study in China is open to people with progressive lung fibrosis (chronic fibrosing ILDs with progressive phenotype) who are at least 18 years old. The purpose of this study is to find out whether a medicine called nintedanib helps people with progressive lung fibrosis. Participants are put into 2 groups randomly, which means by chance. 1 group gets nintedanib as capsules twice a day. The other group gets placebo as capsules twice a day. Placebo capsules look like nintedanib capsules but do not contain any medicine. Participants are in the study for about 1 year. During this time, they visit the study site about 10 times. At some visits, participants perform a lung function test. The doctors check whether study treatment can slow down the loss of lung function. The doctors also regularly check participants' health and take note of any unwanted effects.

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)