Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Prior participant in an Avalyn AP01 study, excluding normal volunteers
Or
2.Patients with no other treatment options with Interstitial Lung Diseases, including but not limited to Idiopathic Pulmonary Fibrosis, fibrosing phenotype Interstitial Lung Disease, pulmonary involvement of scleroderma, rheumatoid lung and silicosis. Prior Sponsor approval of non-Avalyn study rollover patients is required.
3.Diagnosed chronic progressive fibrotic Interstitial Lung Disease, including Idiopathic Pulmonary Fibrosis, without treatment alternatives such as:
a.Not eligible for oral pirfenidone and nintedanib due to national formulary restrictions or lack of regulatory approval
b.Intolerant to oral pirfenidone and nintedanib, if previously offered
c.Not eligible for an ongoing clinical study of AP01 other than this study
4.Age greater than 18 years
5.Able to understand and sign a written informed consent form (ICF)
6.Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
7.Females of childbearing potential (FOCBP) must use a contraceptive method during the clinical study and 30 days after the last dose of pirfenidone solution for inhalation (AP01)

Exclusion Criteria

Disease-Related Exclusions
1.Significant clinical worsening of Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis for AP01 naïve patients between Screening and Day 1, in the opinion of the investigator
2.Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator
3.History of acute Idiopathic Pulmonary Fibrosis exacerbation requiring hospitalization in the last 30 days
4.Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
Medical Exclusions
5.Females with a positive pregnancy test at Screening (AP01 naïve patients) or Baseline (Rollover patients from previous study) or are currently breastfeeding
6.Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma)
7.Any condition other than Interstitial Lung Disease/Idiopathic Pulmonary Fibrosis that, in the opinion of the investigator, is likely to result in the death of the patient within the next 6 months
8.History of severe hepatic impairment or end-stage liver disease or AST or ALT greater than 5 times the upper limit of normal at Screening (AP01 naïve patients)
9.History of end-stage renal disease requiring dialysis
10.Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product (IP) (AP01 naïve patients only)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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