Benefit of High-flow Nasal Cannula on Persistent Dyspnea in Ild
HIGHOXFILD
2 other identifiers
interventional
42
0 countries
N/A
Brief Summary
The main purpose of this study is to evaluate the effects of high-flow nasal therapy (HFNT) oxygen compared to long-term oxygen therapy (LTOT) on dyspnea and quality of life in intersititial lung disease patients with chronic respiratory failure and persistent breathlessness in whom LTOT has already been initiated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 15, 2026
September 27, 2024
January 1, 2024
2 years
January 2, 2024
September 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SGRQ questionnaire : Saint George's Respiratory Questionnaire (symptom component)
Symptom component of SGRQ : Scores range from 0 to 100, with higher scores indicating more limitations.
2 weeks
Secondary Outcomes (28)
Dyspnea assessement : dyspnoea-12
2 weeks
Dyspnea assessement : mMRC: Modified Medical Research Council
2 weeks
Dyspnea assessement : MDP: Multidimensional dyspnea profile
2 weeks
Quality of life (SGRQ questionnaire) : S.George's Respiratory Questionnaire
2 weeks
Quality of life (K-Bild) : The King's Brief Interstitial Lung Disease (KBILD) questionnaire
2 weeks
- +23 more secondary outcomes
Study Arms (2)
Long-Term Oxygen therapy (LTOT) then High Flow Nasal Therapy (HFNT)
OTHER2 weeks of LTOT then 2 weeks of LTOT+HFNT
High Flow Nasal Therapy (HFNT) then Long-Term Oxygen therapy (LTOT)
OTHER2 weeks of LTOT+HFNT then 2 weeks of LTOT
Interventions
Usual care with LTOT for 2 weeks
High Flow Nasal delivered by myAirvo3 (4 hours minimum and during th 3-minute chair rise test, 30L/min, 34°C, identical O2 flow rate as LTOT) for 2 weeks
Eligibility Criteria
You may qualify if:
- Intertitial lung disease
- Persistant dyspnea (mMRC≥3)
- Long-term oxygen therapy at least for 3 months
You may not qualify if:
- Chronic respiratory disease (COPD, lung cancer)
- Pneumothorax,
- Pneumomediastinum,
- Active smoker,
- Patient on non-invasive ventilation or continuous positive airway pressure (CPAP),
- Pregnancy or breastfeeding,
- Unable to read or understand questionnaires,
- No written consent,
- Patients under guardianship,
- No health assurance coverage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Capucine Morélot-Panzini, MD,PhD, Prof
APHP • Assistance Publique des hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
September 27, 2024
Study Start
October 15, 2024
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
October 15, 2026
Last Updated
September 27, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatiqueet des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.