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Clinical Trials/ISRCTN16427067
ISRCTN16427067
Completed
Not Applicable

Randomised, controlled crossover trial to evaluate the Effects of Ambulatory Oxygen on health status in patients with Fibrotic Lung Disease (FLD)

Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)0 sites80 target enrollmentMarch 22, 2016
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ConditionsFibrotic lung diseasesRespiratory

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibrotic lung diseases
Sponsor
Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)
Enrollment
80
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30170904

Registry
who.int
Start Date
March 22, 2016
End Date
December 31, 2017
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients with a diagnosis of idiopathic pulmonary fibrosis (IPF), or with another fibrotic ILD
  • •2\. Aged between 18 and 99 years
  • •3\. Patients whose oxygen saturation (SaO2\) at rest on room air is \=94% and falls\<88% on a baseline 6MWT (performed as part of their routine assessment)
  • •4\. Patients with stable symptoms and treatment during the period of four weeks prior to being recruited into the study, including the two week run in period

Exclusion Criteria

  • •1\.Patients expected to change treatment over the time course of the study, and those meeting criteria for long term oxygen therapy, i.e. hypoxic at rest
  • •2\.Patients with connective tissue disease\-associated ILD or with sarcoidosis with musculoskeletal/joint involvement/symptoms will be excluded due to the potential impact in relation to day\-to\-day mobility
  • •3\.Patients with significant communication or other locomotor difficulties, and/or severe co\-morbidities
  • •4\.Current smokers in view of the potential risks associated with use of supplemental oxygen
  • •5\.Pregnancy
  • •6\.History of symptomatic ischaemic cardiac disease (exertion\-induced chest pain)
  • •7\.Anaemia, Hb\<10g/dl

Outcomes

Primary Outcomes

Not specified

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