Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

HFNT During Exercise in CF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965832
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: HFNT during exercise Device: Standard oxygen therapy/RA Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study to Evaluate the Feasibility of Using High-flow Nasal Therapy During Exercise in Patients With Cystic Fibrosis and Severe Lung Disease
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: HFNT
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 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

Experimental: Standard oxygen
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 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




Primary Outcome Measures :
  1. 6 minute walking distance [ Time Frame: 6 minutes ]
    Change in the 6 minute walking distance (exploratory outcome of interest)


Other Outcome Measures:
  1. Oxygen saturation (SpO2) [ Time Frame: 6 minutes ]
    Mean and Nadir SpO2 during 6MWT (exploratory outcome of interest)

  2. Time to recovery - SpO2 [ Time Frame: 30 minutes ]
    Time to recovery for SpO2 at end of exercise (exploratory outcome of interest)

  3. Transcutaneous CO2 [ Time Frame: 6 minutes and during recovery time (30 minutes) ]
    Mean tCO2 (exploratory outcome of interest)

  4. Respiratory rate (RR) [ Time Frame: 6 minutes and during recovery time (10 minutes) ]
    (exploratory outcome of interest)

  5. Dyspnea [ Time Frame: 6 minutes and during recovery time (10 minutes) ]
    Measured with Borg score (exploratory outcome of interest): 0 no breathlessness to 10 maximal breathlessness

  6. Fatigue [ Time Frame: 6 minutes and during recovery time (10 minutes) ]
    Measured with Borg score (exploratory outcome of interest): 0 no fatigue at all to 10 maximal fatigue

  7. Comfort [ Time Frame: 6 minutes and during recovery time (10 minutes) ]
    Measured with VAS (exploratory outcome of interest): 0 most uncomfortable to 10 very comfortable



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965832


Contacts
Layout table for location contacts
Contact: Giulia Spoletini +4401132069106 giulia.spoletini@nhs.net

Locations
Layout table for location information
United Kingdom
St James's University Hospital, Leeds Teaching Hospital NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Giulia Spoletini       giulia.spoletini@nhs.net   
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Giulia Spoletini LTHT
Principal Investigator: Daniel G Peckham LTHT
Publications:
Layout table for additonal information
Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03965832    
Other Study ID Numbers: RM19/121917
19/LO/0671 ( Other Identifier: REC Reference )
262095 ( Other Identifier: IRAS )
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Leeds Teaching Hospitals NHS Trust:
high-flow nasal therapy
oxygen therapy
Exercise-induced desaturation
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases