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

NCT07129707 | Completed DMC

• 1 other identifier: DieulefitSante
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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)

Keywords

Dyspnea; Exercise; Oxygen inhalation therapy; Pulmonary fibrosis

Outcome Measures

Primary Outcomes (2)

• Time to exercise intolerance

  Measured during a constant work-rate exercise test (70% peak work rate)

  4 times over 2 consecutive days (1 time per experimental condition)

• Isotime dyspnea

  0-10 category-ratio Borg scale

  4 times over 2 consecutive days (1 time per experimental condition)

Secondary Outcomes (3)

• Breathing pattern

  4 times over 2 consecutive days (1 time per experimental condition)

• Gas exchange

  4 times over 2 consecutive days (1 time per experimental condition)

• Quadriceps muscle oxygenation

  4 times over 2 consecutive days (1 time per experimental condition)

Study Arms (4)

Room Air

PLACEBO COMPARATOR

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

Other: Exercise testing

Supplemental Oxygen

ACTIVE COMPARATOR

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

Other: Exercise testing

Nasal high-flow

ACTIVE COMPARATOR

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

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)

Other: Exercise testing

Interventions

Exercise testing 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 oxygen therapy; Room Air; Supplemental Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Dieulefit Santé Centre de Réadaptation: lead

Study Sites (1)

Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé

Dieulefit, Auvergne-Rhône-Alpes, 26220, France

Location

Related Publications (5)

• 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.

  PMID: 35589480 BACKGROUND

• 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.

  PMID: 34749699 BACKGROUND

• 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.

  PMID: 34729862 BACKGROUND

• 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.

  PMID: 34225230 BACKGROUND

• 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.

  PMID: 33185464 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial; Dyspnea; Motor Activity; Pulmonary Fibrosis

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Mathieu Marillier, PhD

  University Grenoble Alps

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover - 4 experimental conditions

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 19, 2025
• Study Start: December 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

FR (1)