Automated Oxygen Titration During Walking in Patients With Lung Fibrosis (OXYWILD)

Respiratory Therapy Clinical Trial

— OXYWILD  

Official title:

OXYWILD - Automated Oxygen Titration With O2matic During Walking in Patients With Fibrotic Interstitial Lung Diseases (F-ILD): A Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465654
• Other study ID #: UAarhus_OXYWILD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: April 15, 2026

Study information

• Verified date: June 2024
• Source: University of Aarhus
• Contact: Janne H Jensen, MSc
• Phone: 78456730
• Email: jannhast[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fibrotic lung disease is a group of severe scarring lung diseases with a dismal prognosis, often leading to respiratory failure and need for oxygen treatment. The symptom burden is often extremely high with dyspnea at rest and increasing dyspnea with exertion. Patients will often need more oxygen during activity thus repeatedly adjustments of oxygen flow rates are required to target an acceptable saturation at rest and during activities. This is impractical and can lead to an undesirable focus on oxygen levels as well as reduced use of the oxygen treatment in everyday life.

There is an urgent need for oxygen equipment that is easy to use to help patients live a life with fever symptom-related restrictions. Closed Loop Oxygen Titration (CLOT) is a new type of optimized oxygen treatment, which automatically adjusts the oxygen flow rate to the exact amount needed for the patient. The CLOT has already been tested and found useful in patients with other lung diseases, however it has not yet been tested in an isolated group of patients with fibrotic lung disease.

The goal of this clinical trial is therefore to study if automatically adjusted oxygen delivery can be useful for patients with fibrotic lung disease who needs oxygen treatment during activity.

The main questions aimed to be answered are: Will participants experience less breathlessness during walking, when the oxygen supply is individually adjusted to maintain an acceptable level of oxygen saturation?

Our hypotheses are that automatically adjusted oxygen dose during walking will results in less breathlessness compared to the usual fixed dose of oxygen. Furthermore, that participants will walk longer and maintain a better oxygen saturation during a walking test when offered automatically adjusted oxygen dose.

Participants will perform two walking tests with both automatically adjusted and fixed dose oxygen in random order, and the difference in sensation of breathlessness will be compared between the two tests.

Description:

Recruitment of participants

Participants with fibrotic lung disease will be recruited by a pulmonary specialist from the Centre for Rare Lung Diseases, Department of Respiratory Diseases and Allergy, Aarhus University Hospital during a routine outpatient visit. If exertional oxygen desaturation is suspected or has been documented by a six-minute walking test the investigator, a pulmonary specialist will inform the patient about the study and ask for study participation.

The patient will be asked to sign the informed consent. The information given to the patient specifies that the informed consent gives access for study personnel to access the medical record for relevant information necessary to complete the study. The written informed consent form will be signed and personally dated by the subject and the person conducting the informed consent conversation.

Ethical considerations

No risk for the patients is considered to be related to participation in the study. The walking tests are conducted by an experienced physiotherapist with solid knowledge about patients with fibrotic lung disease and when to terminate walking tests due to clinical symptoms. Furthermore, patients are enquired to stop the test if they experience discomfort. Walking tests with or without oxygen supply is a part of standard clinical practice for patients with fibrotic lung disease at the Centre of Rare Lung Diseases and the O2matic has been approved for clinical use.

Patients can benefit individually by gaining knowledge about their oxygen need at exercise, and as a group contribute to increased knowledge about the effect of automated oxygen treatment on dyspnea during exercise and on exercise endurance. International guidelines have restricted recommendations for ambulatory oxygen therapy due to limited evidence. This study may contribute to stronger recommendations for the prescription of ambulatory oxygen therapy in the future.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: April 15, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Verified diagnosis of fibrotic interstitial lung disease

• Desaturation during a recent (6 months) 6-minute walk test below 88% on atmospheric air or during an incremental shuttle walking test

• Able to walk at least 50 meters

• Self-reported stable respiratory symptoms in the previous 2 weeks

• Age = 18 years

• Cognitively able to understand and participate in the study

• Written informed consent

Exclusion Criteria:

• Long term oxygen treatment

• A pulmonary or cardiac condition other than fibrotic interstitial lung disease limiting exercise performance

• Unstable heart condition or symptomatic stenotic valve disease

• Any physical condition limiting exercise performance.

• Smoking the previous 24 hours

• Pregnancy

• Anaemia, haemoglobin < 7.3 mmol/l (women) or < 8.3 mmol/l (men)

Related Conditions & MeSH terms

• Fibrosis
• Fibrosis Lung
• Pulmonary Fibrosis
• Respiratory Therapy

Intervention

Other:
• Automated variable dose oxygen treatment
The participant will receive closed loop oxygen titration during a walking test based on oxygen saturation measurements every second measured by a pulse oximeter connected to the O2matic. The participant will every minute during the walking test rate sensation of dyspnea on the BorgCR10 scale.
• Fixed dose oxygen treatment
The participant will receive a fixed oxygen dose during a walking test. The participant will every minute during the walking test rate sensation of dyspnea on the BorgCR10 scale.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Janne Hastrup Jensen	Copenhagen University Hospital, Hvidovre

References & Publications (12)

Bendstrup E, Hyldgaard C, Altraja A, Sjaheim T, Myllarniemi M, Gudmundsson G, Skold M, Hilberg O. Organisation of diagnosis and treatment of idiopathic pulmonary fibrosis and other interstitial lung diseases in the Nordic countries. Eur Clin Respir J. 2015 Jul 1;2. doi: 10.3402/ecrj.v2.28348. eCollection 2015. — View Citation

Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018. — View Citation

Hyldgaard C. A cohort study of Danish patients with interstitial lung diseases: burden, severity, treatment and survival. Dan Med J. 2015 Apr;62(4):B5069. — View Citation

Jacobs SS, Krishnan JA, Lederer DJ, Ghazipura M, Hossain T, Tan AM, Carlin B, Drummond MB, Ekstrom M, Garvey C, Graney BA, Jackson B, Kallstrom T, Knight SL, Lindell K, Prieto-Centurion V, Renzoni EA, Ryerson CJ, Schneidman A, Swigris J, Upson D, Holland AE. Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Nov 15;202(10):e121-e141. doi: 10.1164/rccm.202009-3608ST. Erratum In: Am J Respir Crit Care Med. 2021 Apr 15;203(8):1045-1046. doi: 10.1164/rccm.v203erratum7. — View Citation

King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18. Erratum In: N Engl J Med. 2014 Sep 18;371(12):1172. — View Citation

Kofod LM, Westerdahl E, Kristensen MT, Brocki BC, Ringbaek T, Hansen EF. Effect of Automated Oxygen Titration during Walking on Dyspnea and Endurance in Chronic Hypoxemic Patients with COPD: A Randomized Crossover Trial. J Clin Med. 2021 Oct 20;10(21):482 — View Citation

Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18. — View Citation

Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL. — View Citation

Schneeberger T, Jarosch I, Leitl D, Gloeckl R, Hitzl W, Dennis CJ, Geyer T, Criee CP, Koczulla AR, Kenn K. Automatic oxygen titration versus constant oxygen flow rates during walking in COPD: a randomised controlled, double-blind, crossover trial. Thorax. 2023 Apr;78(4):326-334. doi: 10.1136/thoraxjnl-2020-216509. Epub 2021 Oct 16. — View Citation

Vezina FA, Bouchard PA, Breton-Gagnon E, Dion G, Viglino D, Roy P, Bilodeau L, Provencher S, Denault MH, Saey D, Lellouche F, Maltais F. Automated O2 Titration Alone or With High-Flow Nasal Cannula During Walking Exercise in Chronic Lung Diseases. Respir — View Citation

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. — View Citation

Vivodtzev I, L'Her E, Vottero G, Yankoff C, Tamisier R, Maltais F, Lellouche F, Pepin JL. Automated O2 titration improves exercise capacity in patients with hypercapnic chronic obstructive pulmonary disease: a randomised controlled cross-over trial. Thora — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Borg dyspnea score	Primary outcome is the difference in Borg dyspnea score at isotime between the two endurance shuttle walk test (fixed dose oxygen compared to automated variable dose oxygen). The dyspnea score is rated every minute with the Borg Category-Ratio (CR)10 scale, where 0 is "no dyspnea at all" and 10 is "maximum dyspnea ever experienced".	At baseline and through completion (one day)
Secondary	Walking distance	Difference in walking distance in meters between groups in Endurance shuttle walking test	At baseline and through completion (one day)
Secondary	Walking time	Difference in walking time in seconds between groups in Endurance shuttle walking test	At baseline and through completion (one day)
Secondary	Oxygen flow rate	Difference in average oxygen flow rate (liter/minute) between groups in Endurance shuttle walking test.	At baseline and through completion (one day)
Secondary	Oxygen saturation levels	Difference in time spent in seconds within acceptable oxygen saturation interval (oxygen saturation 90 - 94 percentage and time spent with moderate hypoxemia (oxygen saturation below 88 percentage) and severe hypoxemia (Oxygen saturation below 85 percentage) with moderate hypoxemia (oxygen saturation below 88 percentage) and severe hypoxemia (oxygen saturation below 85 percentage.	At baseline and through completion (one day)
Secondary	Hypoxemia	Time to first moderate hypoxemia and severe hypoxemia	At baseline and through completion (one day)
Secondary	Difference in causes of walking limitations	The participant is asked about factors limiting the walking distance.	At baseline and through completion (one day)