Ambulatory Oxygen in Fibrotic Lung Disease

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004355-20-GB

Enrollment

Unknown

Registered

2014-03-31

Start date

2014-03-20

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 16.1 Level: PT Classification code 10022611 Term: Inter

Interventions

Trade Name: Medical Oxygen Product Name: Medical Oxygen Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: Oxygen Ph. Eur. 100%

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main symptom that occurs in fibrotic lung disease (lung scarring) is breathlessness due to the progressive scarring of the lungs, with a profound impact on daily activities. During exercise, lung fibrosis is often associated with a drop in oxygen saturation which can be corrected by the use of supplemental oxygen. In patients with lung scarring, the main cause of overall worsening quality of life is breathlessness. The principal research question is the study of the impact of supplemental oxygen on health status. We strongly believe that attempts to improve or maintain health status are of crucial importance, especially in this group of respiratory diseases, characterized overall by a poor prognosis and progressive worsening in quality of life. ;Secondary Objective: The secondary research questions aim to better define the effects of supplemental oxygen on quality of life by evaluating global patient assessment, individual respiratory symptoms, symptoms of depression and anxiety, as well as the effect on monitored and patient-recorded activity parameters. In addition, in a subgroup of patients, patients' and carers' experiences regarding the use of ambulatory oxygen and trial participation will be investigated. This could be helpful for further studies, with the aim to strengthen the involvement of patients in respiratory research, and the links with researchers in this field.;Primary end point(s): The main aim of this project is to establish whether supplemental oxygen in patients with fibrotic ILD whose oxygen saturation falls on exertion during sub-massimal test, leads to a significant improvement in their health status. ;Timepoint(s) of evaluation of this end point: At the end of each of the two two-week treatment periods, to compared the effects of ambulatory oxygen on health status.	—

Measure

Time frame

Main Objective: The main symptom that occurs in fibrotic lung disease (lung scarring) is breathlessness due to the progressive scarring of the lungs, with a profound impact on daily activities. During exercise, lung fibrosis is often associated with a drop in oxygen saturation which can be corrected by the use of supplemental oxygen. In patients with lung scarring, the main cause of overall worsening quality of life is breathlessness. The principal research question is the study of the impact of supplemental oxygen on health status. We strongly believe that attempts to improve or maintain health status are of crucial importance, especially in this group of respiratory diseases, characterized overall by a poor prognosis and progressive worsening in quality of life. ;Secondary Objective: The secondary research questions aim to better define the effects of supplemental oxygen on quality of life by evaluating global patient assessment, individual respiratory symptoms, symptoms of depression and anxiety, as well as the effect on monitored and patient-recorded activity parameters. In addition, in a subgroup of patients, patients' and carers' experiences regarding the use of ambulatory oxygen and trial participation will be investigated. This could be helpful for further studies, with the aim to strengthen the involvement of patients in respiratory research, and the links with researchers in this field.;Primary end point(s): The main aim of this project is to establish whether supplemental oxygen in patients with fibrotic ILD whose oxygen saturation falls on exertion during sub-massimal test, leads to a significant improvement in their health status. ;Timepoint(s) of evaluation of this end point: At the end of each of the two two-week treatment periods, to compared the effects of ambulatory oxygen on health status.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes will include dyspnoea scores, global patient assessment, monitored and patient-recorded activity parameters, and Quality of Life (QOL) scores assessed by K-BILD questionnaire. We also aim to assess whether the improvement in 6MWT performance induced by portable oxygen can predict benefit of ambulatory oxygen in day to day living. ;Timepoint(s) of evaluation of this end point: At the end of each of the two two-week treatment periods, to compared the effects of ambulatory oxygen on health status.	—

Measure

Time frame

Secondary end point(s): Secondary outcomes will include dyspnoea scores, global patient assessment, monitored and patient-recorded activity parameters, and Quality of Life (QOL) scores assessed by K-BILD questionnaire. We also aim to assess whether the improvement in 6MWT performance induced by portable oxygen can predict benefit of ambulatory oxygen in day to day living. ;Timepoint(s) of evaluation of this end point: At the end of each of the two two-week treatment periods, to compared the effects of ambulatory oxygen on health status.

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Countries

United Kingdom

Contacts

Public ContactIra Jakupovic

Royal Brompton and Harefield NHS Foundation Trust

i.jakupovic@rbht.nhs.uk02073518109

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 10, 2026