Nasal High-flow Oxygen Therapy During Acute Exercise in Fibrotic Interstitial Lung Disease

NCT ID: NCT07129707

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Interstitial Lung Disease (ILD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover - 4 experimental conditions
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Room Air

Room Air breathing (flow= 0 L/min; inspired fraction of O2= 0.21)

Group Type PLACEBO_COMPARATOR

Exercise testing

Intervention Type OTHER

Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).

Supplemental Oxygen

Supplemental oxygen therapy (flow= 9-12 L/min; inspired fraction of O2= 1.0)

Group Type ACTIVE_COMPARATOR

Exercise testing

Intervention Type OTHER

Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).

Nasal high-flow

Nasal high-flow (flow= 50-70 L/min; inspired fraction of O2= 0.21)

Group Type ACTIVE_COMPARATOR

Exercise testing

Intervention Type OTHER

Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).

Nasal high-flow oxygen therapy

Nasal high-flow oxygen therapy (flow= 50-70 L/min; inspired fraction of O2= 0.50)

Group Type ACTIVE_COMPARATOR

Exercise testing

Intervention Type OTHER

Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).

Interventions

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Exercise testing

Each participant performs a constant work-rate exercise test (70% peak work rate) under the 4 experimental conditions (referred as arms).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* inability to perform a cardiopulmonary exercise test (CPET) on a bicycle ergometer
* participation in a pulmonary rehabilitation program within the last 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dieulefit Santé Centre de Réadaptation

OTHER

Sponsor Role lead

Responsible Party

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Frédéric Hérengt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mathieu Marillier, PhD

Role: STUDY_CHAIR

University Grenoble Alps

Locations

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Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé

Dieulefit, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 35589480 (View on PubMed)

Badenes-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.

Reference Type BACKGROUND
PMID: 34749699 (View on PubMed)

Harada 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.

Reference Type BACKGROUND
PMID: 34729862 (View on PubMed)

Al 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.

Reference Type BACKGROUND
PMID: 34225230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33185464 (View on PubMed)

Other Identifiers

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DieulefitSante

Identifier Type: -

Identifier Source: org_study_id

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