Participants taking part in the study will have a 3 out of 4 chance of receiving the study medication and a 1 out of 4 chance of receiving a placebo. If you receive the study medication, you will be assigned to one of three dose levels: 50 mg, 100 mg or 200 mg.
This study has three periods, the screening period (up to 28 days), the treatment period (approximately 24 weeks) and the follow-up period (approximately 2 weeks),
- Category
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Trial status
Recruiting
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Trial phase
Phase 2 Drug TrialEarly stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
- Registry listing
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ERM Project ID
109384
Trial contact details
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Contact person
Maddy Simson
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Phone
(07) 3163 1369
What you need to know
Inclusion:
-Patients ≥ 40 years old with an IPF diagnosis within the last 5 years
-Patients ≥ 18 years old with a diagnosis of PPF
Exclusion:
-Evidence of other known causes of interstitial lung disease [e.g., domestic and occupational environmental exposures and drug toxicity].
-Evidence of clinically significant lung disease other than IPF/PPF
What is involved for me?
• Review of medical history, current medications and any change in your IPF- or PPF-related symptoms
• Symptom-directed physical examination
• High resolution computerized tomography scan (HRCT scan)
• DLco
• Spirometry
• Vital signs measurement
• 12-lead ECG
• Blood collection for safety laboratory tests
• Additional blood will be collected for:
• Completion of a questionnaire to assess how pulmonary fibrosis affects your daily activities
• Administration of study medication
