ATLAS Study
Research type
Research Study
Full title
A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study)
IRAS ID
255567
Contact name
Bruce Montgomery
Contact email
Sponsor organisation
Avalyn Pharma Inc.
Eudract number
2018-003388-75
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Participants in this study have Idiopathic Pulmonary Fibrosis (IPF), a disease which scars the lungs and causes difficulty breathing. Fibrosis is the build-up of scar tissue which makes the lungs less able to inflate and take oxygen from the air in order to breathe. IPF is a progressive condition and gets worse over time. Currently, there are two drugs, pirfenidone and nintedanib, given orally used to help slow down development of scar tissue in the lungs. These oral medications have side-effects, which in some patients limit their ability to use them; these approved medications are not usually prescribed for patients with early stage IPF. Studies have shown patients may be under-treated due to these factors. In this study, pirfenidone will be inhaled via a nebuliser; a device that converts liquid into a mist that is breathed into the lungs. Earlier studies showed taking the medication this way led to much less pirfenidone in the blood stream. This study will investigate if there are fewer side-effects and if patients can tolerate it well. \nThis study has two parts; Parts A and B. Participants will enter Part A and be randomly assigned, like the flip of a coin, to one of two treatment groups. At the end of Part A, participants may enter Part B if they appear to benefit from treatment. Participants unable to enter Part B will discuss the best treatment options with their doctor. Those entering Part B will continue to use the study drug in the same way as in Part A. The medical need is high for new innovative IPF therapies that are safe and work well. The information collected from this study may enable doctors to make better decisions about treatments to use for IPF and might improve the future treatment of patients with IPF.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0093
Date of REC Opinion
4 Jun 2019
REC opinion
Further Information Favourable Opinion