NCT03965832

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

May 24, 2019

Last Update Submit

April 11, 2022

Conditions

Cystic Fibrosis

Keywords

high-flow nasal therapyoxygen therapyExercise-induced desaturation

Outcome Measures

Primary Outcomes (1)

  • 6 minute walking distance

    Change in the 6 minute walking distance (exploratory outcome of interest)

    6 minutes

Other Outcomes (7)

  • Oxygen saturation (SpO2)

    6 minutes

  • Time to recovery - SpO2

    30 minutes

  • Transcutaneous CO2

    6 minutes and during recovery time (30 minutes)

  • +4 more other outcomes

Study Arms (2)

HFNT

EXPERIMENTAL

Patients who meet the eligibility criteria will be randomized to receive HFNT and then crossover to other device during the study procedures.

Device: HFNT during exerciseDevice: Standard oxygen therapy/RA

Standard oxygen

EXPERIMENTAL

Patients who meet the eligibility criteria will be randomized to receive Standard oxygen and then crossover to HFNT during the study procedures.

Device: HFNT during exerciseDevice: Standard oxygen therapy/RA

Interventions

HFNT during exerciseDEVICE

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.

HFNTStandard oxygen
Standard oxygen therapy/RADEVICE

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

HFNTStandard oxygen

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of CF
  • Severe lung disease (FEV1 ≤40%)

You may not qualify if:

  • Acute viral illness
  • Requirements of \>6 L/min nasal O2 to maintain SpO2 \>88% at rest
  • Acute respiratory acidosis
  • Arthritis exacerbation
  • Inability to obtain informed consent
  • Recent pneumothorax (\<6 weeks)
  • Usual contraindication to exercise testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St James's University Hospital, Leeds Teaching Hospital NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (4)

  • Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.

    PMID: 25742321BACKGROUND

  • Sklar MC, Dres M, Rittayamai N, West B, Grieco DL, Telias I, Junhasavasdikul D, Rauseo M, Pham T, Madotto F, Campbell C, Tullis E, Brochard L. High-flow nasal oxygen versus noninvasive ventilation in adult patients with cystic fibrosis: a randomized crossover physiological study. Ann Intensive Care. 2018 Sep 5;8(1):85. doi: 10.1186/s13613-018-0432-4.

    PMID: 30187270BACKGROUND

  • Cirio S, Piran M, Vitacca M, Piaggi G, Ceriana P, Prazzoli M, Paneroni M, Carlucci A. Effects of heated and humidified high flow gases during high-intensity constant-load exercise on severe COPD patients with ventilatory limitation. Respir Med. 2016 Sep;118:128-132. doi: 10.1016/j.rmed.2016.08.004. Epub 2016 Aug 8.

    PMID: 27578482BACKGROUND

  • Spoletini G, Watson R, Lim WY, Pollard K, Etherington C, Clifton IJ, Peckham DG. Nasal high-flow therapy as an adjunct to exercise in patients with cystic fibrosis: A pilot feasibility trial. J Cyst Fibros. 2021 Sep;20(5):e46-e52. doi: 10.1016/j.jcf.2021.03.005. Epub 2021 Apr 1.

    PMID: 33814320DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Giulia Spoletini

    LTHT

    PRINCIPAL INVESTIGATOR

  • Daniel G Peckham

    LTHT

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

May 24, 2019

Primary Completion

March 1, 2020

Study Completion

December 1, 2020

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

GB(1)