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Home High Flow Oxygen to Reduce Acute Exacerbation of COPD (HIFAE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05196698
Recruitment Status : Recruiting
First Posted : January 19, 2022
Last Update Posted : May 25, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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Brief Summary:
The objective of the study is to evaluate the efficacy of home High Flow Oxygen for the reduction of severe exacerbation following admission for a severe exacerbation of COPD or death against standard oxygen therapy.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: High Flow Oxygen Therapy Other: Long-term oxygen therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
Actual Study Start Date : August 26, 2022
Estimated Primary Completion Date : August 26, 2026
Estimated Study Completion Date : August 26, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: High Flow Oxygen Therapy Other: High Flow Oxygen Therapy

HFOT will be delivered validated medical devices and established as follow:

  • Patient will be acclimatized to HFOT which will aim to achieve a flow of air of 30L/min at a temperature of 34°C using dedicated nasal canula.
  • Once patient acclimatized, oxygen will be entrained in the HFOT device at a flow that will aim to achieve a saturation > 90%. An arterial blood gas will be performed with such oxygen delivery, flowrate and temperature to ensure a PaO2 ≥ 8kPa
Long-Term Oxygen Therapy
Control arm
 Other: Long-term oxygen therapy
LTOT delivery will be performed according to French guidelines


Outcome Measures
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Primary Outcome Measures :
  1. time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease [ Time Frame: 12 months ]
  2. time to death [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change from Baseline in Health-related Quality of Life [ Time Frame: 3 months ]
    Health-related quality of life is evaluated using Saint-Georges Respiratory score

  2. Change from Baseline in Health-related Quality of Life [ Time Frame: 6 months ]
    Health-related quality of life is evaluated using Saint-Georges Respiratory score

  3. Change from Baseline in Health-related Quality of Life [ Time Frame: 12 months ]
    Health-related quality of life is evaluated using Saint-Georges Respiratory score

  4. Change from Baseline in Health-related Quality of Life [ Time Frame: 3 months ]
    Health-related quality of life is evaluated using EuroQol-5D-5L score

  5. Change from Baseline in Health-related Quality of Life [ Time Frame: 6 months ]
    Health-related quality of life is evaluated using EuroQol-5D-5L score

  6. Change from Baseline in Health-related Quality of Life [ Time Frame: 12 months ]
    Health-related quality of life is evaluated using EuroQol-5D-5L score

  7. Change from Baseline in Health-related Quality of Life [ Time Frame: 3 months ]
    Health-related quality of life is evaluated using Hospital anxiety and depression scale

  8. Change from Baseline in Health-related Quality of Life [ Time Frame: 6 months ]
    Health-related quality of life is evaluated using Hospital anxiety and depression scale

  9. Change from Baseline in Health-related Quality of Life [ Time Frame: 12 months ]
    Health-related quality of life is evaluated using Hospital anxiety and depression scale

  10. Change from Baseline in Health-related Quality of Life [ Time Frame: 3 months ]
    Health-related quality of life is evaluated using Leicester Cough Questionnaire score

  11. Change from Baseline in Health-related Quality of Life [ Time Frame: 6 months ]
    Health-related quality of life is evaluated using Leicester Cough Questionnaire score

  12. Change from Baseline in Health-related Quality of Life [ Time Frame: 12 months ]
    Health-related quality of life is evaluated using Leicester Cough Questionnaire score

  13. Change from Baseline in Health-related Quality of Life [ Time Frame: 3 months ]
    Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score

  14. Change from Baseline in Health-related Quality of Life [ Time Frame: 6 months ]
    Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score

  15. Change from Baseline in Health-related Quality of Life [ Time Frame: 12 months ]
    Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score

  16. Change from Baseline in Health-related Quality of Life [ Time Frame: 3 months ]
    Health-related quality of life is evaluated using Pittsburgh sleep quality index score

  17. Change from Baseline in Health-related Quality of Life [ Time Frame: 6 months ]
    Health-related quality of life is evaluated using Pittsburgh sleep quality index score

  18. Change from Baseline in Health-related Quality of Life [ Time Frame: 12 months ]
    Health-related quality of life is evaluated using Pittsburgh sleep quality index score

  19. Number of Adverse events [ Time Frame: 3 months ]
    Imputability of Adverse events is evaluated by investigator

  20. Number of Adverse events [ Time Frame: 6 months ]
    Imputability of Adverse events is evaluated by investigator

  21. Number of Adverse events [ Time Frame: 12 months ]
    Imputability of Adverse events is evaluated by investigator


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with a diagnosis of COPD defined by GOLD guidelines
  2. Admitted in hospital for AECOPD

  3. With severe respiratory impairment defined by one of the following criteria (long-term oxygen therapy (LTOT) criteria):

    • Previously established on long-term oxygen therapy according to the following criteria: PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension or right heart failure on room air in stable condition Or
    • PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension or right heart failure on room air after clinical stabilization during the index admission
  4. Patients affiliated or, beneficiary of a social security cover
  5. Patient who has read and understood the information letter and signed the consent form
  6. For woman of childbearing potential, use of an effective contraception (oestro-progestatives or intra-uterine device or tubal ligation) since at least 1 month and an blood pregnancy test by β-HCG negative at the screening visit, during the duration of the study
  7. For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)

Exclusion Criteria:

  1. Age <18 or > 85 years
  2. Patient treated with chronic NIV with ongoing treatment
  3. Patients diagnosed with obstructive sleep apnea (OSA) treated with CPAP. Diagnosis of OSA will be over-ruled in patient that had a previous overnight polygraphy. For patients who never had an overnight polygraphy, screening for OSA will be made using the STOP-BANG questionnaire. If the results of the STOP-BANG questionnaire (Appendix 1) is >3, an Apnea-link recording will be performed. If AHI>30/h, patient will be excluded.
  4. BMI > 35 kg/m2
  5. Patient admitted for an acute COVID-19 infection

  6. Hypercapnic respiratory failure justifying NIV defined as

    1. An Arterial Blood Gas (ABG) PaCO2 > 7 kPa in stable condition within 6 months
    2. Patients with ABG PaCO2 > 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge
  7. Pregnancy (blood pregnancy test positive) or lactation ongoing
  8. Significant psychiatric disorder or dementia that would prevent adherence to study protocol
  9. Tobacco use < 10 pack-year
  10. Expected survival < 12 months due to any situation other than COPD disease
  11. Refusal of high-flow oxygen therapy
  12. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
  13. Patients already involved in a research protocol that would impact with the outcome measured in the current protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196698


Contacts
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Contact: Antoine CUVELIER, Pr +33232889059 antoine.cuvelier@chu-rouen.fr
Contact: Armelle GUIDOTTI +33232888265 armelle.guidotti@chu-rouen.fr

Locations
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France
UHRouen Recruiting
Rouen, France
Contact: Antoine CUVELIER, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Antoine CUVELIER, Pr Rouen University Hospital
Principal Investigator: Maxime PATOUT, Dr AP-HP La Pitié Salpétrière
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT05196698    
Other Study ID Numbers: 2019/0412/HP
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: May 25, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes