Clinical trial · Interventional
Ambulatory Oxygen in Fibrotic Lung Disease (FLD) (AmbOx)
Randomized, Controlled Crossover Trial to Evaluate the Effects of Ambulatory Oxygen on Health Status in Patients With Fibrotic Lung Disease (FLD).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung; Disease, Fibroid (Chronic) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ambulatory Oxygen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ambulatory oxygen cylinders
- description
- Subjects randomised to have the intervention of portable oxygen for the first two weeks. Only patients with stable symptoms at the end of the 'run in' period and reproducible 6-minute walk distance on the 6MWT during the baseline visit, as a marker of clinical stability of the disease will be randomized. They will be a portable oxygen cylinder during 2 weeks when they realize activities.
- interventionNames
- Drug: Ambulatory Oxygen
- type
- NO_INTERVENTION
- label
- no oxygen cylinders
- description
- Subjects randomised to be on air for the first two weeks of the treatment period.
Primary outcomes (1)
- measure
- change in K-BILD The King's Brief Interstitial Lung Disease Questionnaire health status score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDVisca 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. PMID 30170904
- DERIVEDVisca 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. PMID 28454553