A randomized open-label, phase 1b study of the safety of Pirfenidone Solution for inhalation (AP01) in patients with idiopathic pulmonary fibrosis (ATLAS Study).
To find out if this trial is suitable for you please register below or contact our Clinical Trials Team at email@example.com or phone 6151 0888.
Eligibility & Requirements
- 40 to 90 years of age at screening.
- Clinical symptoms consistent with IPF of ≥ 12 months duration (with or without IPF diagnosis).
Diagnosis of IPF, no more than 48 months before randomization.
- Forced vital capacity between 40% to 90 % predicted at screening.
- DLCO between 30% to 90% at screening.
- Do not have a clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis.
- Not eligible for oral pirfenidone and nintedanib due to national formulary restrictions or intolerant to or unwilling to start oral pirfenidone and nintedanib.
- You will be required to attend monthly visits to Sir Charles Gairdner Hospital for approximately 6 months and then 3 monthly visits for the second part of the study (13 visits over approximately 19 months).
- You will receive study treatment in the form of a nebuliser (two different doses). There is no placebo in this trial.
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