What is AP01 studying for progressive pulmonary fibrosis?

AP01 is being studied to evaluate its safety and effectiveness in treating progressive pulmonary fibrosis (PPF). Researchers aim to see how two doses of inhaled AP01 compare to a placebo when added to standard care. This research is sponsored by Avalyn Pharma Inc. to explore new treatment options for PPF patients.

Who may be eligible for this progressive pulmonary fibrosis clinical trial?

Adults aged 18 years and older with a diagnosis of progressive pulmonary fibrosis may be eligible. Participants must meet specific lung function and disease progression criteria and cannot be currently taking oral pirfenidone. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this progressive pulmonary fibrosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06329401

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation AP01 in Participants With Progressive Pulmonary Fibrosis

Led by Avalyn Pharma Inc. · Updated on 2026-04-06

375

Participants Needed

152

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two doses of inhaled pirfenidone AP01 compared to a placebo, alongside standard care, in people with progressive pulmonary fibrosis PPF over a 52-week period. This randomized, double-blind, placebo-controlled Phase 2b study aims to better understand treatment options for individuals with PPF, a condition characterized by worsening lung fibrosis despite existing therapies. Participants will be randomly assigned to one of three groups a high dose of AP01 twice daily, a low dose of AP01 twice daily, or a placebo inhalation twice daily. The study involves taking inhaled treatments using a pirfenidone solution or placebo, with the goal to evaluate the impact of these treatments on lung function and disease progression over one year. Throughout the study, participants will undergo regular assessments including lung function tests, imaging scans, and quality of life evaluations. Researchers will monitor the effect of the treatments on lung fibrosis, respiratory symptoms, and safety measures. The total participation lasts for 52 weeks, during which participants will attend scheduled visits and complete various tests to track their health and response to the study treatments.

CONDITIONS

Brief Title

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participant meets criteria for progressive pulmonary fibrosis (PPF) defined by lung function decline and/or worsening symptoms despite treatment
Adults aged 18 years or older
Radiological evidence of pulmonary fibrosis on HRCT
Forced vital capacity (FVC) at least 45% of predicted normal at screening
Forced expiratory volume in 1 second (FEV1)/FVC ratio at least 0.7 or above age-adjusted lower limit of normal at screening
Diffusing capacity of lung for carbon monoxide (DLCO) at least 30% of predicted, corrected for hemoglobin at screening
Able to perform acceptable spirometry meeting ATS/ERS criteria
If on nintedanib, must have been on treatment for at least 6 months prior to screening or off for at least 12 weeks if discontinued

You will not qualify if you...

Current or recent (within 3 months) treatment with oral pirfenidone
Elevated liver enzymes (ALT or AST) greater than 3 times the upper limit of normal
Bilirubin level greater than 2 times the upper limit of normal
Severe renal disease with creatinine clearance less than 30 mL/min
Diagnosis of idiopathic pulmonary fibrosis (IPF) according to ATS criteria
Greater extent of emphysema than fibrotic interstitial lung disease on HRCT
Significant clinical worsening of PPF during screening
Unable to meet baseline stability criteria for lung function prior to randomization

Research Team

Craig S. Conoscenti, MD

Daniele Tompkins

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