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A Multinational, Long-Term, Safety And Tolerability, Open-Label Extension Study Of Subjects Who Have Participated In Avalyn Pharma Studies Of Inhaled Antifibrotic Agents (AP-LTE-008 [SAIL])
Rochester, MN
This is an open-label extension study for participants who were previously enrolled in and completed an Avalyn Pharma Sponsored study with an inhaled antifibrotic, such as AP01. Eligible participants will have their final dose of drug at the end of study visit from the lead-in study and first AP-LTE-008 study visit on the same day.
All participants will receive 100 mg inhaled pirfenidone inhalation solution (AP01) taken twice daily using the eFlow Nebulizer System for until such a time that the drug is approved, the participant withdraws from the study, or the study is terminated.
New patients will be trained to use the nebuliser at the first treatment visit. All patients will use the eFlow nebuliser to administer AP01. Hands on training for use and cleaning of the eFlow nebuliser will be performed by site personnel with patients using the study specific instructions for use and quick reference guide provided. The first treatment for new patients will be overseen by clinic personnel.
A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.
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Metformin To Attenuate Progressive Respiratory Decline In Idiopathic Pulmonary Fibrosis (MAVRIC)
Rochester, MN
This is a randomized, placebo-controlled trial of metformin in 400 participants with idiopathic pulmonary fibrosis (IPF) who are at high risk of adverse clinical outcomes based on a proteomic classifier. The primary objective is to assess the safety and efficacy of metformin compared to placebo in participants with IPF who are at high-risk for adverse clinical events.
Approximately 800 participants with IPF will be screened. 400 participants who are at high risk for adverse clinical events (proteomic signature present) will be randomized into receiving metformin (n\~200) or matching placebo (n\~200). Participants that meet the eligibility criteria but do not have the proteomic signature (proteomic signature absent) will be contacted by phone at 12 and 24 months to review medical history.
Closed for Enrollment
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A Phase 2, Randomized Dose-ranging Study To Evaluate The Efficacy Of Tralokinumab In Adults With Idiopathic Pulmonary Fibrosis
Rochester, MN
To study the safety and effectiveness of multiple-doses of tralokinumab on pulmonary function in adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, irreversible, and usually fatal lung disease of unknown cause.
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study To Assess The Efficacy And Safety Of Simtuzumab (GS-6624) In Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Scottsdale/Phoenix, AZ
Jacksonville, FL
Rochester, MN
The purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis.
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A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study To Evaluate The Efficacy And Safety Of Bexotegrast (PLN-74809) For The Treatment Of Idiopathic Pulmonary Fibrosis (BEACON-IPF)
Jacksonville, FL
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of bexotegrast (PLN-74809) for the treatment of idiopathic pulmonary fibrosis (BEACON-IPF).
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A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating The Safety And Efficacy Of Pirfenidone Solution For Inhalation (AP01) In Participants With PPF
Scottsdale/Phoenix, AZ
Rochester, MN
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
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LTRC - Lung Tissue Research Consortium
Rochester, MN
The purpose of this study is to collect lung tissue and blood samples from participants who undergo medically-indicated lung surgery and maintain a bank of specimens from a wide range of participants with varying types of lung disease and progressions.
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Phase 2 Study Of Safety, Tolerability And Efficacy Of Pirfenidone In Patients With Rheumatoid Arthritis Interstitial Lung Disease
Rochester, MN
The purpose of this study is to to assess the safety and tolerability of pirfenidone 2403 mg/day for the treatment of RA-associated interstitial lung disease.
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Prospective Treatment Efficacy In IPF Using Genotype For Nac Selection (PRECISIONS) Trial
Rochester, MN
The purpose of this study is to compare the effect of n-acetylcysteine (NAC) plus standard care with matched placebo plus standard of care in patients diagnosed with idiopathic pulmonary fibrosis (IPF) who have the TOLLIP rs3750920 TT genotype. The study will compare the time to a composite endpoint of relative decline in lung function [10% relative decline in forced vital capacity (FVC), first respiratory hospitalization, lung transplantation, or all-cause mortality] The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.
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Pulmonary Fibrosis Foundation Patient Registry
Rochester, MN
The purpose of the Pulmonary Fibrosis Foundation Patient Registry is to collect data on well-characterized patients with interstitial lung disease, especially idiopathic pulmonary fibrosis, for participation in retrospective and prospective research.
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Utility of the FilmArray Respiratory Pathogen Panel (FARP) in Detecting Pathogens in ILD Patients with Worsening Lung Function
Rochester, MN
The purpose of the study is to describe the frequency with which pathogens will be detected using nasopharyngeal (NP) FilmArray respiratory pathogen panel (FARP) in Interstitial lung disease (ILD) patients with acute exacerbations.
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