An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Condition(s) studied
Investigational drug(s) / intervention(s)
AP01: AP01 will be administered open-label via the eFlow Nebulizer System
Study summary
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.
Eligibility
Primary outcome measure(s)
- To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01). — Through end of study; average of 6 years
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.
Trial sites (85)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| University of Southern California | Los Angeles | California | Recruiting |
| Newport Native MD, Inc. | Newport Beach | California | Recruiting |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Yale University | New Haven | Connecticut | Recruiting |
| Renstar Medical Research | Ocala | Florida | Recruiting |
| Piedmont Healthcare, Inc. | Atlanta | Georgia | Recruiting |
| The University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| University of Maryland | Baltimore | Maryland | Recruiting |
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| Hannibal Regional Healthcare System, Inc. | Hannibal | Missouri | Recruiting |
| Weill Cornell | New York | New York | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | Recruiting |
| Columbia University | New York | New York | Recruiting |
| Piedmont HealthCare, PA | Statesville | North Carolina | Recruiting |
| Southeastern Research Center | Winston-Salem | North Carolina | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| Summit Health | Bend | Oregon | Recruiting |
| The Oregon Clinic Pulmonary East | Portland | Oregon | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Recruiting |
| Temple University Hospital | Philadelphia | Pennsylvania | Recruiting |
| Lowcountry Lung and Critical Care, PA | Charleston | South Carolina | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| El Paso Pulmonary Association, P.A. | El Paso | Texas | Recruiting |
| Baylor College of Medicine | Houston | Texas | Recruiting |
| Intermountain Medical Center | Murray | Utah | Recruiting |
| University of Utah | Salt Lake City | Utah | Recruiting |
| Inova Healthcare | Falls Church | Virginia | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
| CIMER Centro Integral de Medicina Respiratoria | San Miguel de Tucumán | Tucumán Province | Recruiting |
| Investigaciones En Patologias Respiratorias | San Miguel de Tucumán | Tucumán Province | Recruiting |
| Fundación Respirar | Buenos Aires | Argentina | Recruiting |
| Clinica Monte Grande | Buenos Aires | Argentina | Recruiting |
| Instituto Ave Pulmo, Fundacion Enfisema | Buenos Aires | Argentina | Recruiting |
| Centro Respiratorio Quilmes | Buenos Aires | Argentina | Recruiting |
| CINME | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | Recruiting |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Recruiting |
+ 45 more sites — see the full list on the official registry below.
More Avalyn Pharma Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06951217 on ClinicalTrials.gov ↗ ← All trials in the USA