Idiopathic Pulmonary FibrosisNCT04564664
High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis
A study testing Oxygen in people with Idiopathic Pulmonary Fibrosis, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with IPF diagnosis according to the 2018 international consensus guidelines
- Mean SpO2 ≤ 85% during the 6MWT performed under room air conditions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial
Objectives:
- 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.
- 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.
Read more
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Oxygen
- Keywords
- exertional desaturation, high-flow nasal cannula
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal cannula oxygen therapy | Other | Not described Receives: Drug: Oxygen |
| Standard oxygen therapy | Other | Not described Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy
Measured: through study completion, an average of 1 week
Secondary outcomes (3)
Dyspnea and fatigue
Dyspnea and fatigue (Borg scale) at the end of the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Measured: through study completion, an average of 1 week
Oxygen saturation
Peripheral oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Measured: through study completion, an average of 1 week
Muscle oxygen saturation (StO2)
Muscle oxygen saturation (StO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Mar 2019
- Primary completion30 Dec 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Responsible party
- Sponsor
- Investigators
- Eva Balcells Vilarnau, Principal investigator, Hospital del MarDiego Agustín Rodriguez Chiariadia, Study director, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564664
- Sponsor's protocol ID
- 2017/7397/I
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT04564664
- Acronym / sponsor ID
- 2017/7397/I
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- exertional desaturation, high-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula oxygen therapy | Other | Drug: Oxygen |
| Standard oxygen therapy | Other | Drug: Oxygen |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with IPF diagnosis according to the 2018 international consensus guidelines
- Mean SpO2 ≤ 85% during the 6MWT performed under room air conditions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenHigh-flow nasal cannula oxygen therapy vs. standard oxygen therapy | Drug | High-flow nasal cannula oxygen therapy, Standard oxygen therapy |
Primary outcome
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
3 secondary outcomes
Dyspnea and fatigue
Time frame: through study completion, an average of 1 week
Oxygen saturation
Time frame: through study completion, an average of 1 week
Muscle oxygen saturation (StO2)
Time frame: through study completion, an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Balcells Vilarnau principal investigator
Hospital del Mar
Diego Agustín Rodriguez Chiariadia study director
Hospital del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Idiopathic Pulmonary Fibrosis, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time (time frame: through study completion, an average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.