NCT03488628

Brief Summary

High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (COPD), in randomized clinical trials. The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of COPD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

7.3 years

First QC Date

March 26, 2018

Last Update Submit

December 18, 2025

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

respiratory failureoxygen therapyNoninvasive ventilation

Outcome Measures

Primary Outcomes (2)

  • Arterial pH at 24 hours

    Arterial pH at 24 hours, the primary efficacy criteria, is planned to be jointly assessed and analysed with the primary safety criteria (PaO2/FiO2 ratio at 24 hours)

    24 hours

  • PaO2/FiO2 ratio at 24 hours

    PaO2/FiO2 ratio at 24 hours, the primary safety criteria, is planned to be jointly assessed and analysed with the primary efficacy criteria (arterial pH at 24 hours)

    24 hours

Secondary Outcomes (8)

  • Cumulative incidence of tracheal intubation

    28 days

  • Time course of arterial pH

    24 hours

  • Arterial partial pressure in carbon dioxide (PaCO2)

    24 hours

  • Time course of arterial oxygen saturation (SaO2)

    24 hours

  • Self-reported dyspnea score

    24 hours

  • +3 more secondary outcomes

Study Arms (2)

Noninvasive ventilation

ACTIVE COMPARATOR

Noninvasive ventilation delivered through a face mask, in alternance with standard nasal oxygen therapy

Other: Noninvasive ventilation

High-Flow Nasal Oxygen therapy

EXPERIMENTAL

High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher \& Paykel Healthcare,New Zealand) through nasal canula.

Other: High-Flow Nasal Oxygen therapy

Interventions

High-Flow Nasal Oxygen therapyOTHER

High-Flow Nasal Oxygen therapy delivered continuously over the first 24 hours by the AIRVO2® device (Fisher \& Paykel Healthcare,New Zealand) through nasal canula.

High-Flow Nasal Oxygen therapy
Noninvasive ventilationOTHER

Noninvasive ventilation delivered through a face mask, in alternace with satandard nasal oxygen therapy over the first 24 hours

Noninvasive ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Known Chronic Obstructive Pulmonary disease (COPD)
  • respiratory rate or presence of accessory respiratory muscles activity on physical exam
  • moderate exacerbation of COPD as defined by an arteria pH between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (PaCO2) equal or above 45 mm Hg

You may not qualify if:

  • Age below 18
  • Pregnancy
  • Known sleep apnea syndrome
  • Patent treated by noninvasive ventilation at home
  • Not affiliated to French scial security
  • Contraindication to aither Noninvasive ventilation or to High-Flow Nasal Oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'Orléans

Orléans, 45067, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Mai-Anh Nay, MD

    Centre Hospitalier Régional d'Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 5, 2018

Study Start

June 27, 2018

Primary Completion

October 3, 2025

Study Completion

October 30, 2025

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)