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Idiopathic Pulmonary Fibrosis clinical trials

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NCT ID: NCT03300583 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Toward Self-management in ILD

Start date: October 1, 2017
Phase: N/A
Study type: Observational

Treating and caring for people with long term conditions accounts for a substantial proportion of health care resources. Self-management is advocated as a mechanism that can empower service users with long term conditions to choose healthier options and also transform the relationship between service user and caregivers from one in which the former is a passive recipient of care to one in which they are an active partner in decision-making. Interstitial lung disease (ILD) is one such long term condition. Patients with ILD often express concern about the lack of information on possible rehabilitation programmes and other services that could potentially improve self-management of the disease. In addition, there is a general perception about a lack of co-ordination between health care professionals especially in relation to referral to services for comprehensive management of the disease. Therefore, the needs of patients with ILD and their carers, and possible gaps in service provision need to be explored further. In this study, we propose to explore the needs of ILD patients from all types of ILD and all stages of severity and to also involve carers and clinicians. We will conduct three focus groups for patients and carers and six one-to-one interviews with clinicians to explore perceptions about service gaps and needs in two ILD centres in South and North London, UK. This study will provide us with valuable information to develop the building blocks of a self-management resource and will enable us to make it specific to the different types of ILD.

NCT ID: NCT03287414 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis

Start date: December 15, 2017
Phase: Phase 2
Study type: Interventional

This study will investigate the safety and efficacy of VAY736 administered subcutaneously (s.c.) every 4 weeks for 48 weeks. Approximately, 84 subjects will be randomized in a 1:1 ratio on top of local standard of care (SOC), to receive VAY736 or placebo.

NCT ID: NCT03286556 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis, Acute Fatal Form

Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis

STRIVE-IPF
Start date: October 1, 2017
Phase: Phase 2
Study type: Interventional

Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted to date. Considerable preliminary data shows pathological B-cell abnormalities and autoantibodies are present in AE-IPF and associated with disease severity. The experimental therapy here (therapeutic plasma exchange plus rituximab plus intravenous immunoglobulin) is mechanistically targeted to ameliorate autoantibody-mediated pulmonary injury. Anecdotal pilot studies indicate these treatments have significant benefit for a disease syndrome that has, until now, been almost invariably inexorable. This clinical trial has the potential to profoundly affect current paradigms and treatment approaches to patients with AE-IPF.

NCT ID: NCT03281200 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain

Start date: September 29, 2017
Phase: N/A
Study type: Observational

The present study has been designed to characterize IPF patients treated with nintedanib (OFEV®), at time of treatment initiation, with respect to their clinical profile based on real-world data from January 2016 in Spanish Pulmonology Services.

NCT ID: NCT03274544 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Clinical Trial of Chinese Herbal Medicine for Idiopathic Pulmonary Fibrosis (IPF)

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

This open label clinical study will be conducted in School of Chinese Medicine Clinics at The University of Hong Kong (HKU) to preliminarily determine whether treatment with the herbal formula PROLUNG could improve Idiopathic Pulmonary Fibrosis (IPF) symptoms, respiratory function and the quality of life of patients with IPF compared with pretreatment baseline. We propose to recruit 30 participants. The diagnosis and screening will be conducted by respiratory physicians. Those who meet the inclusion criteria will be referred by the expert to the PI. The PI will prescribe the formula in granule form to the participants in Traditional Chinese medicine (TCM) Clinics as usual. Patients will receive 6 months of the herbal treatment and 7 visits. Annual rate of change in forced expiratory vital capacity (FVC) will serve the primary outcome. The St. George's Respiratory Questionnaire (SGRQ) will be used to additionally assess respiratory functions. A standard questionnaire will be administered to obtain information on age, sex, marital status, education, social class, smoking behaviour and respiratory diseases. Other outcome measures include the 36-Item Short Form Survey (SF-36) and the World Health Organization Quality of Life assessment instrument (WHOQOLBREF) by each participant after enrollment.

NCT ID: NCT03268915 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis (IPF) and the 3 Minutes Sit-to-stand Test

ST2-IPF
Start date: February 9, 2017
Phase: N/A
Study type: Interventional

This study is designed to evaluate the reproductibility and the performance of the 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis. To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis in 2 centers (Grenoble university hospital and Lyon university hospital). Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also perform a 3 minutes sit-to-stand test with measurement of oxygen uptake. The investigators will then analyse the results by comparing numbers of cycle, functional response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The investigators will also compare the functional response obtained during the 3 minutes sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test. Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on cycle ergometer.

NCT ID: NCT03261037 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.

NCT ID: NCT03258801 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Pirfenidone as Bridging Therapy for Lung Transplant in Patients Suffering From Idiopathic Pulmonary Fibrosis

Start date: September 2017
Phase: N/A
Study type: Observational

The diagnosis of idiopathic pulmonary fibrosis (IPF) is currently one of the most common diagnoses for patients under evaluation for lung transplantation. In recent years, an absolute increase in prevalence/ incidence of IPF has been observed. There is evidence that patients with IPF on waiting list for lung transplantation might benefit from pirfenidone treatment. Until now, no data are published regarding this important issue in lung transplantation. Primary objective is to determine whether there is a difference in the duration time of mechanical ventilation (weaning) directly after lung transplantation between patients treated with pirfenidone and patients without pirfenidone treatment. The Secondary objectives are to determine whether there are differences between the pirfenidone treatment group and the control group regarding survival after LUTX, the score on the Saint Georges Respiratory Questionnaire and the decline in forced vital capacity (FVC%) In this Investigator initiated, non- interventional single center study , patients on the waiting list for transplant pirfenidone treatment receive oral pirfenidone at the standard dose of 2403 mg per day. The treatment duration will range from 6 to 12 months. A control group will be used to correlate the outcome-parameters for a descriptive comparison. The control group includes patients with IPF on the waiting list who were on another IPF specific (or no) treatment for IPF The Study Population are Patients aged between 40-70 years who are admitted to the lung transplantation department and fulfill the international criteria for idiopathic pulmonary fibrosis ( existence of a usual interstitial pneumonia (UIP) pattern in the high-resolution computed tomography (HRCT) is necessary). Variables: Duration of mechanical ventilation after LUTX (hours), Forced Vital capacity relative to reference value at baseline (FVC0%), Forced Vital capacity relative to reference value after 6 months (FVC6%),Forced Vital capacity relative to reference value after 12 months (FVC12%) Study Size: 30 patients in the Pirfenidone group, 20 patients in the control group. For the primary Endpoint, the mean, standard deviation, median, minimum and maximum of the weaning time of patients who received a pirfenidone treatment, as well as of patients from the control group will be computed and presented in a table. Additionally, a Kaplan-Meier curve will be estimated and plotted alongside the respective 95% CI calculated using the method of Brookmeyer and Crowley. Furthermore, a stepwise linear regression using forward selection and Age, RBMI, FVC0%, (FVC6%-FVC0%), TLC, FEV1% and ECMO, as well as the pirfenidone treatment as predictors will be computed. The null hypothesis is that the pirfenidone treatment has no influence on the weaning time. The according model coefficient estimate and standard error will be used to test the null hypothesis using a t-test at significance level α=0.05. For the secondary endpoints, the mean, standard deviation, median, minimum and maximum of patients who received a pirfenidone treatment, as well as of patients from the control group will be computed and presented in a tableStepwise Cox Regression using forward selection and Age, RBMI, FVC0%, (FVC6%-FVC0%) and ECMO, as well as the pirfenidone treatment as predictors will be computed in order to compare the treatment and the control group a . If p-values are calculated for the secondary endpoint analysis, they serve only descriptive purposes. Therefore no multiple testing corrections are applied.

NCT ID: NCT03229343 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis.

PALIF
Start date: October 2017
Phase: N/A
Study type: Interventional

Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life. In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients. In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not). Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF.

NCT ID: NCT03222648 Recruiting - Quality of Life Clinical Trials

Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis

Rehab-IPF
Start date: September 22, 2017
Phase: N/A
Study type: Interventional

In this single centre non-randomised pilot cohort study we wish to quantify the effect of a twice weekly, 8 week, structured responsive exercise training programme on exercise tolerance, symptoms and health related quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). We also wish to assess the effect of exercise training on fibrotic processes causing IPF through measurement of blood biomarkers of disease activity.