High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

• ClinicalTrials.gov Identifier: NCT04564664
• Recruitment Status: Completed
• First Posted: September 25, 2020
• Last Update Posted: August 13, 2021
• Sponsor: Parc de Salut Mar
• Collaborator: Hospitales Universitarios Virgen del Rocío
• Information provided by (Responsible Party): Parc de Salut Mar

Tracking Information

• First Submitted Date: September 14, 2020
• First Posted Date: September 25, 2020
• Last Update Posted Date: August 13, 2021
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2020)

Endurance time [ Time Frame: through study completion, an average of 1 week ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 7, 2021)

• Dyspnea and fatigue [ Time Frame: through study completion, an average of 1 week ]
  Dyspnea and fatigue (Borg scale) at the end of the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
• Oxygen saturation [ Time Frame: through study completion, an average of 1 week ]
  Peripheral oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
• Muscle oxygen saturation (StO2) [ Time Frame: through study completion, an average of 1 week ]
  Muscle oxygen saturation (StO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy

Original Secondary Outcome Measures (submitted: September 21, 2020)

• Dyspnea and fatigue [ Time Frame: through study completion, an average of 1 week ]
  Dyspnea and fatigue (Borg scale) at the end of the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
• Oxygen saturation [ Time Frame: through study completion, an average of 1 week ]
  Oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis
• Official Title: High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial

Brief Summary

Objectives:

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. 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.

Method: multicenter crossover clinical trial. Patients with IPF presenting oxygen desaturation during the six-minute walking test (6MWT) (SpO2 mean ≤ 85%) will be included consecutively . Each subject evaluated will perform initially an incremental CPET to evaluate the patient's maximum exercise capacity. Supplemental oxygen will be applied to maintain SpO2 >85% with a Venturi mask. Maximum exercise capacity and the appropriate final oxygen inspiratory fraction (FiO2) needed for the following tests will be determined.

Posteriorly each patient will perform two constant load CPET (at 75% of the maximum workload achieved with the incremental CPET); one with standard oxygen therapy and the other one with HFNC oxygen therapy. Endurance time, dyspnea and leg fatigue and oxygen saturation (peripheral and muscular) will be recorded.

Evaluation measures: Endurance time, dyspnea and leg fatigue (Borg scale), and oxygen saturation.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

Drug: Oxygen

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

Study Arms

• High-flow nasal cannula oxygen therapy
  Intervention: Drug: Oxygen
• Standard oxygen therapy
  Intervention: Drug: Oxygen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2020): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 30, 2021
• Actual Primary Completion Date: December 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04564664
• Other Study ID Numbers: 2017/7397/I
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Parc de Salut Mar
• Original Responsible Party: Same as current
• Current Study Sponsor: Parc de Salut Mar
• Original Study Sponsor: Same as current
• Collaborators: Hospitales Universitarios Virgen del Rocío

Investigators

• Principal Investigator: Eva Balcells Vilarnau; Hospital del Mar
• Study Director: Diego Agustín Rodriguez Chiariadia; Hospital del Mar

• PRS Account: Parc de Salut Mar
• Verification Date: September 2020