drugset / Trial / NCT02286063
Ambulatory Oxygen in Fibrotic Lung Disease (FLD) (AmbOx)
Phase 4
Completed
70 enrolled
Royal Brompton & Harefield NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust · collabNational Institute for Health Research, United Kingdom · collab
RandomizedCrossoverSingle-blindTreatment
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. 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.
Timeline
- Start
- 2014-08
- Primary completion
- 2018-01-31
- Completion
- 2018-01-31
Publications
- Visca D, Mori L, Tsipouri V, Fleming S, Firouzi A, Bonini M, Pavitt MJ, Alfieri V, Canu S, Bonifazi M, Boccabella C, De Lauretis A, Stock CJW, Saunders P, Montgomery A, Hogben C, Stockford A, Pittet M, Brown J, Chua F, George PM, Molyneaux PL, Margaritopoulos GA, Kokosi M, Kouranos V, Russell AM, Birring SS, Chetta A, Maher TM, Cullinan P, Hopkinson NS, Banya W, Whitty JA, Adamali H, Spencer LG, Farquhar M, Sestini P, Wells AU, Renzoni EA. Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):759-770. doi: 10.1016/S2213-2600(18)30289-3. Epub 2018 Aug 28.
- Visca D, Tsipouri V, Mori L, Firouzi A, Fleming S, Farquhar M, Leung E, Maher TM, Cullinan P, Hopkinson N, Wells AU, Banya W, Whitty JA, Adamali H, Spencer LG, Sestini P, Renzoni EA. Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial. Trials. 2017 Apr 28;18(1):201. doi: 10.1186/s13063-017-1912-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxygen | Other / unclassified | — | — |