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Clinical Trials/ACTRN12623000835640
ACTRN12623000835640
Not yet recruiting
未知

A Phase II Randomised Crossover Trial to Assess Feasibility of Domiciliary Nasal High Flow for Chronic Breathlessness in People with Interstitial Lung Disease

Alfred Health0 sites20 target enrollmentAugust 4, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Alfred Health
Enrollment
20
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 4, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • oAge 18 years and over
  • oconfirmed ILD as determined by:
  • oradiological evidence on CT chest scan (within last 5 years) or
  • opulmonary function tests with DLco less than 60% and/or restrictive spirometry (within last 3 years)
  • ophysician confirmed optimisation of treatment of ILD
  • obreathlessness as determined by modified medical research council dyspnea score (mMRC) greater than on equal to 2
  • onot currently on home, long\-term, oxygen therapy for greater than or equal to 16h/day and not meeting criteria for home long\-term oxygen therapy (i.e., SpO2 at rest greater than or equal to 92%)
  • opatients using only portable oxygen therapy on exertion remain eligible
  • oable to provide written informed consent
  • ocapable of completing assessments and following the study procedures.

Exclusion Criteria

  • oAcute exacerbation of ILD, including but not limited to:
  • ochest infection in the past 4 weeks (unstable)
  • oon home long\-term oxygen therapy for greater than or equal to 16h/day
  • oenrolled in other clinical trials which may impact breathlessness (as determined by the study investigator)
  • ocommenced (or required to commence during the trial) new treatment for ILD, including but not limited to, anti\-fibrotic, opioids or benzodiazepines in the last 14 days
  • oprevious adverse reaction to NHF
  • oclinician predicted survival less than or equal to 3 months
  • opregnant or breast feeding
  • ocurrent alcoholism or drug abuse
  • ountreated pneumothorax

Outcomes

Primary Outcomes

Not specified

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