An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvalyn Pharma Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physician.
Male subjects and female subjects of childbearing potential (FOCBP) agree to use highly effective contraception measures from the time of first dose of study drug (for the male subject) or the signing of the informed consent form (ICF) (for the female subject), during the study, and until 90 days after the last dose of study drug. Subjects agree not to donate eggs or sperm during the same period.
Disqualifiers
Have not previously participated in an Avalyn-sponsored inhaled antifibrotic lead-in study or if the subject was permanently discontinued from the lead-in study for any reason. Subjects who discontinued study drug but continued to attend study visits are ineligible.
Subjects who experienced an exacerbation of asthma or of chronic obstructive pulmonary disease (COPD) requiring oral or systemic corticosteroids within 3 months of Day 1 (Screening/Baseline Visit).
Subjects who experienced an acute exacerbation of IPF (IPF subjects are excluded from the US and Canada) or of PPF within 3 months of Day 1 (Screening/Baseline Visit).
Participation in a concurrent clinical study or in a clinical study in which any other investigational drug product aside from the Avalyn nebulized antifibrotic medication from their lead-in study was administered within the previous 30 days, or 5 half-lives of the previously administered investigational product, whichever is shorter. Subjects may be enrolled in registries.
Trial design
Design model
Single group
Treatments tested in this trial
AP01
Combination productAP01 will be administered open-label via the eFlow Nebulizer System
Treatment groups
340 Participants
are divided into 1 treatment groupGroup A: Open-label AP01 treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 yearsSponsors and contacts
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Source ClinicalTrials.gov