Interstitial Lung Disease (ILD)PID-OXacuteNCT07129707
Nasal High-flow Oxygen Therapy During Acute Exercise in Fibrotic Interstitial Lung Disease
A study testing Exercise testing in people with Interstitial Lung Disease (ILD), run by Dieulefit Santé Centre de Réadaptation at 1 site in France.
Trial summary
Hallmarks of fibrotic interstitial lung disease (f-ILD) include severe hypoxemia, dyspnea and exercise limitation. Although ambulatory oxygen (O2) therapy is widely prescribed, standard low-flow O2 systems (nasal prongs) fail to meet patients' inspiratory demand on exertion resulting in incomplete correction of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- Exercise testing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of fibrotic interstitial lung disease (regardless of etiology)
- age ≥18 years
- modified Medical Research Council scale ≥1
- stable condition (no acute exacerbation within the preceding 3 months)
Who cannot join
- inability to perform a cardiopulmonary exercise test (CPET) on a bicycle ergometer
- participation in a pulmonary rehabilitation program within the last 6 months
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé
Dieulefit, Auvergne-Rhône-Alpes, 26220
About this study
Official title: Does Nasal High-flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?
Hallmarks of fibrotic interstitial lung disease (f-ILD) include severe hypoxemia, dyspnea and exercise limitation. Although ambulatory oxygen (O2) therapy is widely prescribed, standard low-flow O2 systems (nasal prongs) fail to meet patients' inspiratory demand on exertion resulting in incomplete correction of hypoxemia and limited symptomatic relief. Nasal high-flow O2 therapy (NHFO2) delivers heated, humidified, and O2-enriched air at high flow rates. It has recently emerged as a promising alternative to overcome the pre-specified limitations: NHFO2 is more effective in correcting hypoxemia and reducing dyspnea vs standard O2 therapy and consistently improved exercise capacity in f-ILD. In fact, NHF per se may exert independent physiological benefits such as washout of the anatomical dead space and reduced work of breathing. However, the respective effect of respiratory support and improved oxygenation on dyspnea and exercise tolerance remain unexplored in f-ILD. To address this gap in knowledge, this prospective, randomized-controlled trial aimed to disentangle the i) independent and ii) combined effects of respiratory support and supplemental O2 on dyspnea and exercise tolerance in patients with f-ILD.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- Exercise testing
- Keywords
- Dyspnea, Exercise, Oxygen inhalation therapy, Pulmonary fibrosis
- Medical subject headings
- Lung Diseases, Interstitial, Dyspnea, Motor Activity, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise testingOther
Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).
| Study group | Role | What they receive |
|---|---|---|
| Room Air | Placebo comparator | Room Air breathing (flow= 0 L/min; inspired fraction of O2= 0.21) Receives: Other: Exercise testing |
| Supplemental Oxygen | Active comparator | Supplemental oxygen therapy (flow= 9-12 L/min; inspired fraction of O2= 1.0) Receives: Other: Exercise testing |
| Nasal high-flow | Active comparator | Nasal high-flow (flow= 50-70 L/min; inspired fraction of O2= 0.21) Receives: Other: Exercise testing |
| Nasal high-flow oxygen therapy | Active comparator | Nasal high-flow oxygen therapy (flow= 50-70 L/min; inspired fraction of O2= 0.50) Receives: Other: Exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exercise intolerance
Measured during a constant work-rate exercise test (70% peak work rate)
Measured: 4 times over 2 consecutive days (1 time per experimental condition)
Isotime dyspnea
0-10 category-ratio Borg scale
Measured: 4 times over 2 consecutive days (1 time per experimental condition)
Secondary outcomes (3)
Breathing pattern
Respiratory inductive plethysmography
Measured: 4 times over 2 consecutive days (1 time per experimental condition)
Gas exchange
Earlobe capnography
Measured: 4 times over 2 consecutive days (1 time per experimental condition)
Quadriceps muscle oxygenation
Near-infrared spectroscopy
Measured: 4 times over 2 consecutive days (1 time per experimental condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Dec 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover - 4 experimental conditions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dieulefit Santé Centre de Réadaptation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frédéric Hérengt, Dieulefit Santé Centre de Réadaptation
- Investigators
- Mathieu Marillier, PhD, Study chair, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129707
- Sponsor's protocol ID
- DieulefitSante
- Acronym
- PID-OXacute
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be available from the contact person on reasonable request.
Publications
Girault C, Boyer D, Jolly G, Carpentier D, Beduneau G, Frat JP. [Operating principles, physiological effects and practical issues of high-flow nasal oxygen therapy]. Rev Mal Respir. 2022 May;39(5):455-468. doi: 10.1016/j.rmr.2022.03.012. Epub 2022 May 16. French.
PubMed 35589480Badenes-Bonet D, Cejudo P, Rodo-Pin A, Martin-Ontiyuelo C, Chalela R, Rodriguez-Portal JA, Vazquez-Sanchez R, Gea J, Duran X, Caguana OA, Rodriguez-Chiaradia DA, Balcells E. Impact of high-flow oxygen therapy during exercise in idiopathic pulmonary fibrosis: a pilot crossover clinical trial. BMC Pulm Med. 2021 Nov 8;21(1):355. doi: 10.1186/s12890-021-01727-9.
PubMed 34749699Harada J, Nagata K, Morimoto T, Iwata K, Matsunashi A, Sato Y, Tachikawa R, Ishikawa A, Tomii K. Effect of high-flow nasal cannula oxygen therapy on exercise tolerance in patients with idiopathic pulmonary fibrosis: A randomized crossover trial. Respirology. 2022 Feb;27(2):144-151. doi: 10.1111/resp.14176. Epub 2021 Nov 2.
PubMed 34729862Al Chikhanie Y, Veale D, Verges S, Herengt F. The effect of heated humidified nasal high flow oxygen supply on exercise tolerance in patients with interstitial lung disease: A pilot study. Respir Med. 2021 Sep;186:106523. doi: 10.1016/j.rmed.2021.106523. Epub 2021 Jun 29.
PubMed 34225230Jacobs 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.
PubMed 33185464Thivent S, Ginoux M, Verges S, Herengt F, Marillier M. Determinants of Improved Dyspnea and Exercise Tolerance With Nasal High-Flow O2 Therapy in Fibrotic Interstitial Lung Disease: A Pilot Physiological Study. Respirology. 2026 Jul;31(7):732-744. doi: 10.1002/resp.70251. Epub 2026 Apr 9.
PubMed 41957926
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nasal High-flow Oxygen Potentiate the Effects of Rehabilitative Exercise Training in Chronic Fibrotic Interstitial Lung Disease?
- ClinicalTrials.gov ID
- NCT07129707
- Acronym / sponsor ID
- PID-OXacute / DieulefitSante
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- Dyspnea, Exercise, Oxygen inhalation therapy, Pulmonary fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Dieulefit Santé Centre de RéadaptationUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hallmarks of fibrotic interstitial lung disease (f-ILD) include severe hypoxemia, dyspnea and exercise limitation. Although ambulatory oxygen (O2) therapy is widely prescribed, standard low-flow O2 systems (nasal prongs) fail to meet patients' inspiratory demand on exertion resulting in incomplete correction of hypoxemia and limited symptomatic relief. Nasal high-flow O2 therapy (NHFO2) delivers heated, humidified, and O2-enriched air at high flow rates. It has recently emerged as a promising alternative to overcome the pre-specified limitations: NHFO2 is more effective in correcting hypoxemia and reducing dyspnea vs standard O2 therapy and consistently improved exercise capacity in f-ILD. In fact, NHF per se may exert independent physiological benefits such as washout of the anatomical dead space and reduced work of breathing. However, the respective effect of respiratory support and improved oxygenation on dyspnea and exercise tolerance remain unexplored in f-ILD. To address this gap in knowledge, this prospective, randomized-controlled trial aimed to disentangle the i) independent and ii) combined effects of respiratory support and supplemental O2 on dyspnea and exercise tolerance in patients with f-ILD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Crossover - 4 experimental conditions
| Arm | Type | Receives |
|---|---|---|
| Room Air | Placebo comparator | Other: Exercise testingRoom Air breathing (flow= 0 L/min; inspired fraction of O2= 0.21) |
| Supplemental Oxygen | Active comparator | Other: Exercise testingSupplemental oxygen therapy (flow= 9-12 L/min; inspired fraction of O2= 1.0) |
| Nasal high-flow | Active comparator | Other: Exercise testingNasal high-flow (flow= 50-70 L/min; inspired fraction of O2= 0.21) |
| Nasal high-flow oxygen therapy | Active comparator | Other: Exercise testingNasal high-flow oxygen therapy (flow= 50-70 L/min; inspired fraction of O2= 0.50) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of fibrotic interstitial lung disease (regardless of etiology)
- age ≥18 years
- modified Medical Research Council scale ≥1
- stable condition (no acute exacerbation within the preceding 3 months)
Key exclusion criteria (2 listed)
- inability to perform a cardiopulmonary exercise test (CPET) on a bicycle ergometer
- participation in a pulmonary rehabilitation program within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise testingEach participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms). | Other | Nasal high-flow, Nasal high-flow oxygen therapy, Room Air, Supplemental Oxygen |
Primary outcome
Time to exercise intolerance
Time frame: 4 times over 2 consecutive days (1 time per experimental condition)
Measured during a constant work-rate exercise test (70% peak work rate)
Isotime dyspnea
Time frame: 4 times over 2 consecutive days (1 time per experimental condition)
0-10 category-ratio Borg scale
3 secondary outcomes
Breathing pattern
Time frame: 4 times over 2 consecutive days (1 time per experimental condition)
Gas exchange
Time frame: 4 times over 2 consecutive days (1 time per experimental condition)
Quadriceps muscle oxygenation
Time frame: 4 times over 2 consecutive days (1 time per experimental condition)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 35589480Girault C, Boyer D, Jolly G, Carpentier D, Beduneau G, Frat JP. [Operating principles, physiological effects and practical issues of high-flow nasal oxygen therapy]. Rev Mal Respir. 2022 May;39(5):455-468. doi: 10.1016/j.rmr.2022.03.012. Epub 2022 May 16. French.
- Background: PubMed 34749699Badenes-Bonet D, Cejudo P, Rodo-Pin A, Martin-Ontiyuelo C, Chalela R, Rodriguez-Portal JA, Vazquez-Sanchez R, Gea J, Duran X, Caguana OA, Rodriguez-Chiaradia DA, Balcells E. Impact of high-flow oxygen therapy during exercise in idiopathic pulmonary fibrosis: a pilot crossover clinical trial. BMC Pulm Med. 2021 Nov 8;21(1):355. doi: 10.1186/s12890-021-01727-9.
- Background: PubMed 34729862Harada J, Nagata K, Morimoto T, Iwata K, Matsunashi A, Sato Y, Tachikawa R, Ishikawa A, Tomii K. Effect of high-flow nasal cannula oxygen therapy on exercise tolerance in patients with idiopathic pulmonary fibrosis: A randomized crossover trial. Respirology. 2022 Feb;27(2):144-151. doi: 10.1111/resp.14176. Epub 2021 Nov 2.
- Background: PubMed 34225230Al Chikhanie Y, Veale D, Verges S, Herengt F. The effect of heated humidified nasal high flow oxygen supply on exercise tolerance in patients with interstitial lung disease: A pilot study. Respir Med. 2021 Sep;186:106523. doi: 10.1016/j.rmed.2021.106523. Epub 2021 Jun 29.
- Background: PubMed 33185464Jacobs 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.
- Derived from this study: PubMed 41957926Thivent S, Ginoux M, Verges S, Herengt F, Marillier M. Determinants of Improved Dyspnea and Exercise Tolerance With Nasal High-Flow O2 Therapy in Fibrotic Interstitial Lung Disease: A Pilot Physiological Study. Respirology. 2026 Jul;31(7):732-744. doi: 10.1002/resp.70251. Epub 2026 Apr 9.
- Individual participant dataSharing planned: Undecided. Individual participant data will be available from the contact person on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Marillier, PhD study chair
University Grenoble Alps
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise testing in people with Interstitial Lung Disease (ILD), run by Dieulefit Santé Centre de Réadaptation at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to exercise intolerance (time frame: 4 times over 2 consecutive days (1 time per experimental condition)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07129707, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.