Lung; Disease, Fibroid (Chronic) Clinical Trial
— AmbOxOfficial title:
Randomized, Controlled Crossover Trial to Evaluate the Effects of Ambulatory Oxygen on Health Status in Patients With Fibrotic Lung Disease (FLD).
Verified date | June 2018 |
Source | Royal Brompton & Harefield NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 31, 2018 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Brompton Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Royal Brompton & Harefield NHS Foundation Trust | Aintree University Hospitals NHS Foundation Trust, National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in K-BILD The King's Brief Interstitial Lung Disease Questionnaire health status score | The mean change vs baseline in the K-BILD health status score on and off ambulatory oxygen will be compared by using either a paired t-test or Wilcoxon signed rank test, as appropriate to the distribution of the data. To allow assessment of the effect of baseline values on treatment and any other potential confounders, regression with robust variances or linear mixed models will be used. STATA software will be used for statistical analysis. | February 2017 (up to 3 years) | |
Secondary | Dyspnoea scores | assessed by the San Diego shortness of breath questionnaire. | 2 weeks | |
Secondary | Global assessment of change in walking ability and exertional breathlessness as better, the same or worse. | 2 weeks | ||
Secondary | Quality of life as assessed by SGRQ and the hospital anxiety and depression score | 2 weeks | ||
Secondary | Sense wear activity monitor measures of daily number of steps walked, daily expenditure and time spent at different levels of activity. | 1 week | ||
Secondary | Continuous oxygen saturation for 48 hours at weekly intervals | 48 hours | ||
Secondary | Individual questions specifically related to activity from both the k-BILD and the SOBQ questionnaires | 2 weeks | ||
Secondary | Qualitative assessment of the impact of ambulatory oxygen | semi-structured open-ended interviews in a subset of 20 patients and their carers | 2 weeks of treatment |