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

• Status: Completed
• Trial end date: 2018-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Aintree University Hospitals NHS Foundation Trust; Liverpool University Hospitals NHS Foundation Trust; National Institute for Health Research, United Kingdom

Criteria

Inclusion Criteria:

• IPF or another fibrotic ILD (including fibrotic NSIP, fibrotic organising pneumoni, and fibrotic hypersensitivity pneumonitis)

• patients aged 18 - 99 yrs

• Desaturation ≤ 88% on a 6MWT on room air

• Stable respiratory symptoms in the 4 weeks preceding the trial including the run in period

Exclusion Criteria:

• Patients meeting criteria for long term oxygen therapy, including hypercapnic patients

• Patients expected to change treatment during the course of the study

• Significant locomotor or communication difficulties and/or severe co-morbidities

• Patients with sarcoidosis or connective tissue disease affecting the musculoskeletal system

• Current smokers

• Pregnancy