Ambulatory Oxygen in Fibrotic Lung Disease

Phase 1

Active, not recruiting

• Conditions: Fibrotic Lung Diseases (FLDs) are chronic and progressive conditions resulting in substantial morbidity and mortality. The cardinal symptom of all fibrotic Interstitial Lung Diseases (ILDs) is shortness of breath. Although initially present only on strenuous activities, this unfortunately progresses until even routine activities of daily living become severely limited. This has a devastating impact on Quality of Life (QOL).; MedDRA version: 16.1Level: PTClassification code 10022611Term: Interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-004355-20-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-31
• Last Update Posted: 2017-04-03

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Fibrotic Lung diseaseDisease (FLD) patients aged 18 – 99 yrs
2.Desaturation = 88% on a 6MWT on room air
3.Stable respiratory symptoms in the 4 weeks preceding the trial

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Patients meeting criteria for long term oxygen therapy, including hypercapnic patients
2.Patients expected to change treatment during the course of the study
3.Significant locomotor or communication difficulties
4.Patients with sarcoidosis or connective tissue disease affecting the musculoskeletal system
5.Current smokers
6. Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified