Whistle-PF Trial

Northern Ireland Clinical Research Facility
Principal Investigator/s: Dr Dermot Linden
Name of the Study: Whistle-PF Trial
Why is this Study important?
Idiopathic Pulmonary Fibrosis (IPF) is a serious chronic fibrotic lung-scarring disease that results in loss of lung elasticity, capacity, and function with a mean survival of ~2-3 years from time of diagnosis. Current therapeutic options for IPF are limited to drugs that modestly slow the rate of lung function decline and come with significant safety and tolerability liabilities that limit their use in patients. Therefore, IPF remains a high unmet medical need for more effective and better tolerated therapeutic approaches.
What is the Research question/aim?:
The primary aim of this study is to characterise the efficacy of a range of doses (50 mg, 100 mg or 200 mg of ENV-101, or PBO) in patients (over 40 years old) with IPF at 24 weeks and identify the lowest effective dose based on overall benefit:risk
What the Study involves:
Patients will participate in a screening period of approximately 28 days followed by a treatment period of 24 weeks, and 2-week follow-up period. Spirometry and administration of a questionnaire; Living with Pulmonary Fibrosis (L-PF) will be carried out at the screening visit and again at follow-up visits at Weeks 4, 8, 12, 16, 20 and 24. The overall study duration will be 18 months.
Who can take part in the Study?
Patients with Idiopathic Pulmonary Fibrosis (IPF)
Contact information
Paul Masson - Research physiologist | paul.masson@belfasttrust.hscni.net
Danielle Dawson - Research nurse | danielle.dawson@belfasttrust.hscni.net
NI Clinical Research Facility,
U Floor, Belfast City Hospital
Lisburn Road,
Belfast BT9 7AB
Telephone: 02895040342
Location:
NI Clinical Research Facility,
U Floor, Belfast City Hospital,
Lisburn Road, Belfast, BT9 7AB
Tel:+44 (0)28 9504 0342
Email:NICRF@qub.ac.uk
