Nasal High Flow to Maintain the Benefits of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease Patients

NCT03882372 | Terminated

• 1 other identifier: PPR-NHF
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Pulmonary rehabilitation; Nasal high flow

Outcome Measures

Primary Outcomes (2)

• Endurance capacity

  Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.

  The endurance capacity will be assessed at baseline

• Endurance capacity

  Patients will perform a constant workload exercise testing at 75% of the maximal workload achieved during the incremental cardiopulmonary exercise testing.

  The endurance capacity will be assessed post-intervention (after 6months)

Secondary Outcomes (29)

• Quality of life: Saint George's Respiratory Questionnaire

  The quality of life will be assessed at baseline

• Quality of life: Saint George's Respiratory Questionnaire

  The quality of life will be assessed at post-intervention (after 6months)

• Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test

  The quality of life will be assessed at baseline and post-intervention for a total time frame of 6month

• Quality of life: Chronic Obstructive Pulmonary Disease Assessement Test

  The quality of life will be assessed post-intervention (after 6months)

• Exacerbations

  The number of exacerbations will be assessed for a total time frame of 6month

Study Arms (2)

Nasal high flow

EXPERIMENTAL

Following baseline assessment, patients randomized to the nasal high flow arm will be equipped with a nasal high flow device (myAIRVO2) administrated through the Optiflow nasal canula. Flow will be set at the highest flow tolerated (20-30 L/min): initially 30 L/min, progressively decrease if not tolerated. Temperature will be set between 34-37°C according to the tolerance : initially 37°C and decreased if not tolerated. Patients will be asked to use the device 8h per day. Patients under long-term oxygen will preserve their usual flow. The usual prescribed oxygen flow will then be titrated during nasal high flow to maintain the same baseline transcutaneous oxygen saturation as their conventional oxygen therapy (≥ 90%) to prevent any oxygen dilution effect of nasal high flow.

Device: Nasal high flow

Usual care

NO INTERVENTION

Patient randomized to the control group will have no other specific intervention than their usual care. Patients under long-term oxygen will preserve their usual flow.

Interventions

Nasal high flow DEVICE

See arm description.

Nasal high flow

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Bois-Guillaume, 76230, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine Cuvelier, MD, PhD, Prof

  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

  PRINCIPAL INVESTIGATOR

• Jean-François Muir, MD, Prof

  ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France

  STUDY CHAIR

• Maxime Patout, MD, Msc

  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

  STUDY CHAIR

• Tristan Bonnevie, Msc

  ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Haute Normandie Research and Biomedical Innovation, Rouen, France

  STUDY CHAIR

• Francis-Edouard Gravier, Msc

  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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be unaware of the patient's allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind randomized study.

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: July 22, 2019
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

FR (1)