Whistle-PF a new oral treatment for patients with Pulmonary Fibrosis

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
Respiratory, Infectious Disease and Oncology
Trial status
Recruiting
Trial phase
Phase 2 Drug Trial
Early stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
Registry listing
NCT06422884
ERM Project ID
109384

Trial contact details

Contact person
Maddy Simson
Email
RIOClinicalTrials@mater.org.au
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

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