Protocol Number:
1199.214
Study Name:
A Double Blind, Randomized, Placebo-Controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients with Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
This study is in follow-up
Age Group:
Adult
Background Information:
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Protocol Number:
Study Name:
The Exercise Therapy for Advanced Lung Disease Trial: Response and Adaptation to Aerobic Exercise in Patients with Interstitial Lung Disease
Age Group:
Adult
Background Information:
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Protocol Number:
1199.247
Study Name:
A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Age Group:
Adult
Background Information:
The purpose of this study is to compare the safety and effect of an oral (by mouth) treatment, nintedanib, to placebo, in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD). This would be demonstrated as a reduction in lung function decline (FVC) over 52 weeks.
National Clinical Trial (NCT) identifier on clinicaltrials.gov: NCT02999178
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Protocol Number:
Study Name:
Effect of Sleep Duration and Insomnia on Interstitial Lung Disease (ILD) and Pulmonary Arterial Hypertension (PAH)
Age Group:
Adult
Background Information:
We hypothesize that sleep disruption, sleep restriction, and sleep quality are not only all impacted in IPF and PAH, but are directly associated with important outcomes, such as hospitalization and transplantation and death. We aim to administer the Insomnia Severity Index (IDI), Pittsburgh Sleep Quality Index (PSQI) and Functional Outcomes of Sleep Questionnaire (FOSQ) to all WHO Group 1 PAH patients and ILD patients in the Advanced Lung Disease Program over the course of this study.
Principle Investigator: Nargues Weir, MD
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Protocol Number:
PULSE-PHPF-001
Study Name:
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2).
Age Group:
Adult
Background Information:
The purpose of this research study is to investigate the safety of pulsed, inhaled nitric oxide and how well it is tolerated in subjects with pulmonary hypertension (PH) associated with pulmonary fibrosis (PF) on long term oxygen therapy.
National Clinical Trial (NCT) identifier on clinicaltrials.gov: NCT03267108
Principle Investigator: Christopher King, MD
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Protocol Number:
GA39831
Study Name:
An Observational Study To Assess Disease-Relevant Outcomes Using Home Monitoring Devices In Patients With Idiopathic Pulmonary Fibrosis (STARMAP)
Age Group:
Adult
Background Information:
The overall objective of this study is to find out if the use of home-based mobile Health tools and patient-reported measures can give us a picture to see IPF progression and its impact on patients over time. This will be done by determining the usefulness and reliability of daily hand-held spirometry measurements, judging physical functional capacity as measured by a step-counting and sleep monitoring watch, and by observing other features of disease behavior (symptoms and quality of life) using patient-reported outcome (PRO) surveys.
Principle Investigator: Steven Nathan, MD
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Protocol Number:
1199.225
Study Name:
An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD)
This study is in follow-up
Age Group:
Adult
Background Information:
This study is being done to evaluate the long-term safety and tolerability of the study drug called Nintedanib in subjects with Systemic Sclerosis and associated Interstitial Lung Disease. Nintedanib has not been approved by the U.S. Food and Drug Administration (FDA) to treat Systemic Sclerosis and associated Interstitial Lung Disease and is experimental for this study. It has been approved by the FDA to treat Idiopathic Pulmonary Fibrosis, a disease similar to Systemic Sclerosis related lung fibrosis.
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