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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 23 words Secondary endpoints: details revised at 1 of 3 entries · Site details revised at 6 of 154 sites · Publications: details revised at 2 of 2 entries Show 3 more changesShow less
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 6 of 154 sites
    • Publications: details revised at 2 of 2 entries
  2. Study sites: 152 to 154v17
  3. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 152 of 152 sitesv16 Show 1 more changeShow less
    • Site details revised at 152 of 152 sites
  4. Re-verified, no change to tracked fieldsv15
  5. Study sites: 145 to 152v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 146 to 145v13
  2. Primary and study completion dates: Apr 2026 to Jun 2027 Enrollment target: 300 to 375 · Study sites: 135 to 146 · Publications: details revised at 1 of 2 entriesv12 Show 3 more changesShow less
    • Enrollment target: 300 to 375
    • Study sites: 135 to 146
    • Publications: details revised at 1 of 2 entries
  3. Study sites: 118 to 135 Eligibility criteria expanded, about 15 words · Secondary endpoints reorderedv11 Show 2 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints reordered

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 101 to 118v10
  5. Study sites: 83 to 101v9
  6. Study sites: 89 to 83v8
  7. Study sites: 72 to 89v7
  8. Study sites: 29 to 72 Publications: details revised at 1 of 2 entriesv6 Show 1 more changeShow less
    • Publications: details revised at 1 of 2 entries
  9. Study sites: 8 to 29 Eligibility criteria expanded, about 40 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 40 words

    See this version in full on ClinicalTrials.gov ↗

  10. Study title revised Study description expanded, about 4 wordsv4 Show 1 more changeShow less
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  11. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 230 to 300 · Study sites: 0 to 8 · Start date changed from estimate of Mar 2024 to Apr 3, 2024 · 1 morev3 Show 4 more changesShow less
    • Enrollment target: 230 to 300
    • Study sites: 0 to 8
    • Start date changed from estimate of Mar 2024 to Apr 3, 2024
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  12. Primary endpoint revised Eligibility criteria shortened, about 6 words · Secondary endpoints: 4 to 3 · Study title expanded, about 2 wordsv2 Show 3 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 4 to 3
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.
Trial Details
NCT Number NCT06329401
Lead Sponsor Avalyn Pharma Inc.
Collaborators: DevPro Biopharma
Conditions Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, Pulmonary Fibrosis Secondary to Systemic Sclerosis, Pulmonary Fibrosis, Interstitial Lung Disease, Interstitial Lung Disease, Interstitial Lung Disease Due to Connective Tissue Disease (Disorder), Interstitial Lung Disease in Patients With Rheumatoid Arthritis, Interstitial Lung Disease With Progressive Fibrotic Phenotype in Diseases Classified Elsewhere +2 more
Enrollment 375 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov