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Ambulatory Oxygen in Fibrotic Lung Disease (FLD) (AmbOx)

NCT02286063 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-06-26

No results posted yet for this study

Summary

The main aim of this project is to establish whether ambulatory oxygen in patients with fibrotic ILD whose oxygen saturation falls ≤ 88% on a 6MWT, leads to a significant improvement in health status. The core of the project will be a four week randomised, crossover controlled trial of ambulatory oxygen used during daily activities. The optimal Oxygen flow rate is determined by titration at screening visit and administered during activity for a two-week period, compared to two weeks off oxygen.

Conditions

  • Lung; Disease, Fibroid (Chronic)

Interventions

DRUG

Ambulatory Oxygen

The IMP investigated in this study is medical oxygen (PL 15929/005), manufactured by Air Liquide Ltd. UK. Oxygen is a colourless, odourless gas with molecular weight 32, a boiling point of 183.1°C (at 1 bar) and a density of 1.355 kg/m3 (at 15°C and 1013mb). Oxygen is present in the atmosphere at 21% and is an absolute necessity for life. Each of the four oxygen companies across the UK provide a light and a standard weight oxygen cylinder. Ambulatory Oxygen will be given to the Oxygen arm.

Sponsors & Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Elizabeth Renzoni, Dr · RB&HFT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286063 on ClinicalTrials.gov