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. The study will consist of a Screening/Baseline Visit, an open-label Treatment Period, and a Follow-up/End of Study (EOS) phone call. During the open-label Treatment Period, subjects will receive study drug (AP01 from their lead-in study). Subjects will remain on study for a period of time as based on regulatory region. Subjects will complete an EOS follow-up phone call approximately 2 weeks after their last dose of study drug. A paper dosing diary will be used to monitor adherence along with returns of any unused investigational product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
340
AP01 will be administered open-label via the eFlow Nebulizer System
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).
The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), oxygen saturation, spirometry, physical exams, blood chemistry, and quality of life assessments.
Time frame: Through end of study; average of 6 years
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on lung function the change from baseline in forced vital capacity (FVC) will be evaluated.
FVC will be evaluated via spirometry.
Time frame: Through end of study; average of 6 years
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on stabilization of disease.
Stabilization of disease will be based on computational analysis of quantitative high-resolution computed tomography (HRCT) to assess the extent and pattern of interstitial lung disease present on the HRCT scans (methodologies developed by Qureight).
Time frame: Through end of study; average of 6 years
To evaluate the long-term impact of Avalyn nebulized antifibrotic medications on subject-reported quality of life (QoL).
This outcome will evaluate the change from baseline in the 'Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire' (L-PF) total score. The L-PF is a 23-point questionnaire with lower scores equating to 'less symptomatic' and higher scores equating to 'more symptomatic.'
Time frame: Through end of study; average of 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGRenstar Medical Research
Ocala, Florida, United States
RECRUITINGPiedmont Healthcare, Inc.
Atlanta, Georgia, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGHannibal Regional Healthcare System, Inc.
Hannibal, Missouri, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITINGPiedmont HealthCare, PA
Statesville, North Carolina, United States
RECRUITINGSoutheastern Research Center
Winston-Salem, North Carolina, United States
RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
RECRUITING...and 34 more locations