INFINITE: Randomised Crossover Trial of Domiciliary Nasal High Flow for Chronic Breathlessness in People with Interstitial Lung Disease

Subject area of study: Interstitial lung disease (ILD)

Brief outline: INFINITE will investigate long-term domiciliary NHF therapy use in patients with ILD and severe breathlessness, who do not qualify for home long-term oxygen therapy (administered for >16 hours/day). This study will explore if domiciliary NHF therapy affects breathlessness, sleep, activity, and quality of life in people with ILD. In addition, this study will investigate the inflammation pathways in ILD and to explore if NHF mediates inflammatory response in people with ILD.

The study has been approved by the Alfred Ethics Committee (#365/23)

Who is eligible to participate?

  • Age 18 years and over
  • confirmed ILD as determined by:
    • radiological evidence on CT chest scan (within last 5 years) or
    • pulmonary function tests with DLco<60% and/or restrictive spirometry (within last 3 years)
  • physician confirmed optimisation of treatment of ILD
  • breathlessness as determined by mMRC score ≥ 2
  • not currently on home, long-term, oxygen therapy for ≥ 16h/day and not meeting criteria for home long-term oxygen therapy (i.e., SpO2 at rest≥ 92%)
  • patients using only portable oxygen therapy on exertion remain eligible
  • able to provide written informed consent
  • capable of completing assessments and following the study procedures.

What does the study involve?

Participants will be randomly allocated according to the randomisation procedure. The intervention will be delivered as a domiciliary therapy. Participants will be instructed to use the NHF device for a minimum of 7 hours overnight for each night of the NHF therapy period, and additionally as needed during daytime.

NHF device (F&P AIRVO3 – air only)

  • Arm 1 – NHF therapy for 4 weeks, followed by usual care for 4 weeks with a one-week washout between periods.
  • Arm 2 – Usual care for 4 weeks, followed by NHF therapy for 4 weeks with a one-week washout between periods.

Department: Respiratory Research@Alfred
Recruitment start date:  Monday 9 September 2024
Recruitment end date:  TBC
Contact person title: Ms
Contact person first name: Catherine
Contact person last name: Buchan
Contact email: c.buchan@alfred.org.au
Ethics Committee Project Number: 365/23
Do you have advertising approval?: Yes
Approved by: Alfred