Status:
COMPLETED
Ambulatory Oxygen in Fibrotic Lung Disease (FLD) (AmbOx)
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Liverpool University Hospitals NHS Foundation Trust
National Institute for Health Research, United Kingdom
Conditions:
Lung; Disease, Fibroid (Chronic)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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....
Detailed Description
The planned non-commercial study is a randomised, controlled crossover trial of ambulatory oxygen against no ambulatory oxygen over a four week period (two weeks on ambulatory oxygen and two weeks on ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02286063
Start Date
August 1 2014
End Date
January 31 2018
Last Update
June 26 2018
Active Locations (1)
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1
Royal Brompton Hospital
London, United Kingdom, SW3 6NP