Clinical trial NCT03882372: Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients
Official title: Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Pulmonary rehabilitation
Nasal high flow
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized study.
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) is a major cause of disability and mortality worldwide. This systemic disease progressively leads to dyspnea and exercise capacity impairment. Pulmonary rehabilitation effectively improves exercise capacity, dyspnea and quality of life in patients with COPD. However, its benefits progressively fade over time due to several factors such as the lack of regular exercise activity, dyspnea, airway secretions, hematosis impairment and acute exacerbations which can lead to hospitalization and accelerated muscle wasting.

Nasal high flow (NHF) is a support used to deliver heated and humidified high flow air (up to 60 L/min) through nasal canula providing promising physiological benefits such as positive airway pressure or upper airway carbon dioxide washout. It can be used in association with oxygen and offers the advantage to overtake the patient's inspiratory flow, providing a stable inspired fraction of oxygen. Nasal high flow has widely been studied in pediatric and adult intensive care units and seems better than conventional oxygen therapy and as effective as noninvasive ventilation with regards to mortality to treat hypoxemic acute respiratory failure.

More recently, several studies have shown that long-term nasal high flow could contribute to improve exercise capacity, dyspnea, airway secretion removal, hematosis, reduced acute exacerbations and subsequent hospitalizations in patients with COPD.

Based on these results, the primary aim of this study is to assess whether long-term nasal high flow treatment can help COPD patients to better maintain their endurance capacity following a course of pulmonary rehabilitation.

Detailed description: Experimental design:

Patients achieving their last pulmonary rehabilitation session will be approached to participate in this study.

Eligible patients who agree to participate in the study and sign informed consent will perform two baseline visit assessments:

First visit: Incremental cardiopulmonary exercise testing. Second visit: Other baseline assessment (see outcome section), including a constant workload exercise testing at 75% of the maximal workload achieved during the incremental exercise testing.

Then, patients will then be randomized to one of the following two arms:

* Nasal high flow,
* Usual care.

After 6 months, patients will be invited to perform the same assessment as during the second baseline visit.

Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease stage III to IV;
* With or without long-term oxygen therapy;
* Having completed a course of pulmonary rehabilitation within the last 4 weeks (at least 18 sessions).

Exclusion Criteria:

* Did not complete a course of pulmonary rehabilitation;
* Using noninvasive ventilation or constant positive airway pressure treatment;
* Tracheostomy;
* Nasal high flow intolerance;
* Pregnancy or likely to be;
* Unable to consent;
* Patients under guardianship.

Primary outcomes:
measure: Endurance capacity
timeFrame: The endurance capacity will be assessed at baseline
measure: Endurance capacity
timeFrame: The endurance capacity will be assessed post-intervention (after 6months)
Secondary outcomes:
measure: Quality of life: Saint George's Respiratory Questionnaire
timeFrame: The quality of life will be assessed at baseline
measure: Quality of life: Saint George's Respiratory Questionnaire
timeFrame: The quality of life will be assessed at post-intervention (after 6months)
measure: Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
timeFrame: The quality of life will be assessed at baseline and post-intervention for a total time frame of 6month
measure: Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test
timeFrame: The quality of life will be assessed post-intervention (after 6months)
measure: Exacerbations
timeFrame: The number of exacerbations will be assessed for a total time frame of 6month
measure: Hospitalizations
timeFrame: The number of hospitalizations will be assessed for a total time frame of 6month
measure: Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
timeFrame: The quadriceps muscle thickness will be assessed at baseline
measure: Muscle function (1) : quadriceps muscle (rectus femoris) cross-sectional area
timeFrame: The quadriceps muscle thickness will be assessed at baseline and post-intervention for a total time frame of 6month
measure: Muscle function (2) : bioimpedance
timeFrame: The overall muscle function using bioimpedance will be assessed post-intervention (after 6months)
measure: Exercise capacity
timeFrame: The distance performed during the six-minute walk test will be assessed at baseline
measure: Exercise capacity
timeFrame: The distance performed during the six-minute walk test will be assessed post-intervention (after 6months)
measure: Respiratory muscle function (1) : maximal inspiratory pressure
timeFrame: Maximal inspiratory pressure will be assessed at baseline
measure: Respiratory muscle function (1) : maximal inspiratory pressure
timeFrame: Maximal inspiratory pressure will be assessed post-intervention (after 6months)
measure: Respiratory muscle function (2) : maximal expiratory pressure
timeFrame: Maximal expiratory pressure will be assessed at baseline
measure: Respiratory muscle function (2) : maximal expiratory pressure
timeFrame: Maximal expiratory pressure will be assessed post-intervention (after 6months)
measure: Respiratory muscle function (3) : sniff test
timeFrame: Sniff test will be assessed at baseline
measure: Respiratory muscle function (3) : sniff test
timeFrame: Sniff test will be assessed post-intervention (after 6months)
measure: Parasternal electromyogram
timeFrame: Parasternal electromyogram will be assessed at baseline
measure: Parasternal electromyogram
timeFrame: Parasternal electromyogram will be assessed post-intervention (after 6months)
measure: Physical activity (1) : steps per day
timeFrame: Steps per day will be assessed during 14 days following inclusion
measure: Physical activity (1) : steps per day
timeFrame: Steps per day will be assessed during 14 days after 6months of intervention
measure: Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
timeFrame: The time spent during activities superior to 3 metabolic equivalent per day will be assessed 14 days following inclusion
measure: Physical activity (2) : time spent during activities superior to 3 metabolic equivalent per day
timeFrame: The time spent during activities superior to 3 metabolic equivalent per day will be assessed during 14 days after 6months of intervention
measure: Quality of sleep (1) : Visual Analogue Scale
timeFrame: The quality of sleep using a Visual Analogue Scale will be assessed at baseline
measure: Quality of sleep (1) : Visual Analogue Scale
timeFrame: The quality of sleep using a Visual Analogue Scale will be assessed post-intervention (after 6months)
measure: Quality of sleep (2) : pittsburgh scale
timeFrame: The quality of sleep using the pittsburgh scale will be assessed at baseline
measure: Quality of sleep (2) : pittsburgh scale
timeFrame: The quality of sleep using the pittsburgh scale will be assessed post-intervention (after 6months)
measure: Adherence to treatment : days of utilization during the follow-up
timeFrame: The number of days that the nasal high flow device was used throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
measure: Adherence to treatment : hours of utilization per day
timeFrame: The number of hours of utilization per day throughout the follow-up will be assessed post-intervention in the nasal high flow arm for a total time frame of 6 months
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
Study officials:
affiliation: Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
name: Antoine Cuvelier, MD, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
name: Jean-François Muir, MD, Prof
role: STUDY_CHAIR
affiliation: Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France
name: Maxime Patout, MD, Msc
role: STUDY_CHAIR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France
name: Tristan Bonnevie, Msc
role: STUDY_CHAIR
affiliation: ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory I
name: Francis-Edouard Gravier, Msc
role: STUDY_CHAIR
References: