HFNT During Exercise in CF

Summary

Cystic fibrosis (CF) is a genetic condition characterised by recurrent lung infections, inflammation and progressive lung damage. Patients with CF and advanced lung disease are limited when exercising and performing activities of daily life, due to increased breathlessness and lower oxygen levels.

Exercise is an important part of treatment in CF, having been shown to slow down the lung disease and improve quality of life. Patients with CF are encouraged to exercise both at home and during hospital admissions, even when the lung disease is advanced. Often, oxygen therapy is used in patients whose oxygen levels are otherwise too low during. This, however, does not improve their breathlessness.

Recently, a device to deliver air at flows higher than what other device allow has become available. High flow nasal therapy (HFNT) provides patients with air or a blend of air and oxygen at flows up to 60 L/min. HFNT can improve oxygen levels and reduce shortness of breath in many situations both in the acute and chronic setting. HFNT was shown to improve the tolerance to exercise in patients with other respiratory conditions (chronic obstructive pulmonary disease).

In CF, HFNT is routinely used for patients admitted with acute respiratory failure (inability to maintain adequate oxygenation) with positive results.

In this study, the Investigators aim to understand if HFNT can improve the exercise tolerance in patients with CF and advanced lung disease, by reducing breathlessness and avoiding the drop in oxygenation observed during simple training.

The Investigators propose a short study to assess if further large clinical trials are feasible and practical, and will therefore collect preliminary data to have some results to use for planning other studies. All patients who are admitted in the Leeds Regional Adult CF Unit will be considered for participation in the study.

Conditions

• Cystic Fibrosis

Interventions

DEVICE

HFNT during exercise

6-minute walking test performed initially on HFNT. HFNT will be set with an inspiratory flow rate at 45-55 L/min (maximal tolerated flow), temperature at 37°C or 34°C if perceived as too warm, and fraction on inspired oxygen (FiO2) as at baseline conditions during exercise. Participants will then cross-over to repeat the test on baseline conditions.

DEVICE

Standard oxygen therapy/RA

6-minute walking test performed on baseline conditions. Participants will then be cross over to repeat the test on HFNT

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Giulia Spoletini · LTHT

• Daniel G Peckham · LTHT

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-24

Primary Completion

2020-03-01

Completion

2020-12-01

Countries

• United Kingdom

Study Locations