None listed
Conditions
Brief summary
Interstitial lung disease (ILD) is a group of chronic lung diseases of different causes which lead to symptoms of breathlessness, fatigue, reduced exercise tolerance and poor quality of life. There are limited medical treatments available to date for the majority of patients with ILD. Although ambulatory oxygen is commonly prescribed for patients with ILD suffering significant breathlessness or low oxygen levels during exercise, its clinical benefits are uncertain. Potential adverse effects include increased systemic oxidative stress and the negative impact on patients’ mental well-being from such a burdensome treatment. In addition, the use of oxygen therapy has significant costs for both patients and the health care system. Ambulatory oxygen is usually delivered using oxygen cylinders. Portability and comfort of oxygen cylinders are important factors which prevent patients from using ambulatory oxygen as prescribed. The new lightweight portable oxygen concentrator (POC) may be an attractive alternative to oxygen cylinders. This study aims to compare the effects of ambulatory oxygen with room air delivered via portable concentrator on health outcomes, including exercise capacity, symptoms, activity levels, systemic oxidative stress and inflammation, in patients with chronic ILD and low oxygen levels during exercise.
Interventions
Participants randomised to have supplemental intranasal ambulatory oxygen via Inogen One G2 portable concentrator as the ambulatory oxygen therapy. They will be provided the device for use at home and in the community during exertion for 3 months. There is no specific prescription for the frequency or duration of use. Participants can use the device as much or as little as they choose, with the intention that they use it during periods of exertion. The portable oxygen concentrator will be admini
Participants randomised to have supplemental intranasal ambulatory oxygen via Inogen One G2 portable concentrator as the ambulatory oxygen therapy. They will be provided the device for use at home and in the community during exertion for 3 months. There is no specific prescription for the frequency or duration of use. Participants can use the device as much or as little as they choose, with the intention that they use it during periods of exertion. The portable oxygen concentrator will be administering at level 6 for all participants. Therapy usage will be monitored using a 7-day usage diary prior to each visit and the number of operated hours of portable concentrators.
Sponsors
Dr Yet Hong Khor
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to give written informed consent * Chronic interstitial lung disease of any aetiology * Able to perform a 6-minute walk test * Desaturates to < 90% on room air during the 6-minute walk test * Modified Medical Research Council Dyspnoea Scale greater than or equal to 1 * Participated in pulmonary rehabilitation within the 12 months prior to enrolment or has declined the offer of participation in pulmonary rehabilitation.
Exclusion criteria
* Current domiciliary or ambulatory oxygen use * Patients meeting criteria for long term oxygen therapy based on measured arterial partial pressure of oxygen (defined as stable daytime PaO2 less than or equal to 55 mmHg, or stable daytime PaO2 56-59 mmHg with evidence of hypoxic organ damage (including right heart failure, pulmonary hypertension or polycythaemia) * Significant communication or locomotor difficulties * Current smokers * Patients with concurrent chronic obstructive pulmonary disease (FEV1/FVC <60% and elevated RV/TLC ratio) * Unstable disease in the last 4 weeks before screening * Pregnancy
Outcome results
None listed