NCT04564664

Brief Summary

Objectives:

  1. 1.To evaluate endurance time during cardiopulmonary exercise test (CPET) performance comparing standard oxygen therapy to high-flow nasal cannula (HFNC) oxygen therapy in subjects with idiopathic pulmonary fibrosis (IPF) with exertional desaturation.
  2. 2.To assess oxygenation level (peripheral and muscular) as well as dyspnea and fatigue during exercise in IPF subjects with exertional desaturation using oxygen supplementation with HFNC compared with standard oxygen supplementation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

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

Study Start

First participant enrolled

March 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

August 13, 2021

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

September 14, 2020

Last Update Submit

August 7, 2021

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

exertional desaturationhigh-flow nasal cannula

Outcome Measures

Primary Outcomes (1)

  • Endurance time

    Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy

    through study completion, an average of 1 week

Secondary Outcomes (3)

  • Dyspnea and fatigue

    through study completion, an average of 1 week

  • Oxygen saturation

    through study completion, an average of 1 week

  • Muscle oxygen saturation (StO2)

    through study completion, an average of 1 week

Study Arms (2)

High-flow nasal cannula oxygen therapy

OTHER
Drug: Oxygen

Standard oxygen therapy

OTHER
Drug: Oxygen

Interventions

OxygenDRUG

High-flow nasal cannula oxygen therapy vs. standard oxygen therapy

High-flow nasal cannula oxygen therapyStandard oxygen therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with IPF diagnosis according to the 2018 international consensus guidelines
  • Mean SpO2 ≤ 85% during the 6MWT performed under room air conditions

You may not qualify if:

  • Fibrotic interstitial lung diseases other than IPF
  • Chronic obstructive pulmonary disease (COPD)
  • Inability to perform a complete CPET due to osteo-articular or cognitive limitations
  • End-stage lung disease
  • Severe pulmonary hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Eva Balcells Vilarnau

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

  • Diego Agustín Rodriguez Chiariadia

    Hospital del Mar

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 25, 2020

Study Start

March 1, 2019

Primary Completion

December 30, 2020

Study Completion

March 30, 2021

Last Updated

August 13, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)