COPDNCT06578156
Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD
A study testing Nasal High Flow Cannula and Nasal Low Flow Cannula in people with COPD, run by University of Miami at 1 site in United States.
Trial summary
This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD
- What is being tested?
- Nasal High Flow Cannula and Nasal Low Flow Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to consent
- Age 18 years or older
- Diagnosis of COPD
- Ability to ambulate without assistance
- Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all
Who cannot join
- Pregnancy
- Being on bedrest
- Inability to consent or cooperate with the study
- Using of > 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime
- Hemodynamic instability (resting heart rate > 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)
- Metal implants in the thoracic regions (pacemakers, Automatic Implantable Cardioverter Defibrillator (AICD), plates, screws, rods, and disc replacements)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Saramaria Afanador Castiblanco, M.D., 3052432568, saramaria.afanador@miami.edu
Saramaria Afanador Castiblanco, M.D.
About this study
Official title: Physiologic Effects of Nasal High Flow on Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.
- Conditions
- COPD
- Being tested
- Nasal High Flow Cannula, Nasal Low Flow Cannula
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High Flow CannulaDevice
High flow nasal cannula is a device that provides heated and humidified high flow gases. In-person. Depending on participant's availability, up to 6 times
Nasal Low Flow CannulaDevice
Low flow nasal cannula is a device that provides low flow gases. In-person. Depending on participant's availability, up to 6 times
| Study group | Role | What they receive |
|---|---|---|
| Nasal High Flow Cannula | Experimental | Nasal High Flow cannula at 70 liters per minute for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to Nasal Low Flow Cannula at less than or equal to 4 liters per minute with supplemental oxygen for 30 minutes Receives: Device: Nasal High Flow Cannula; Device: Nasal Low Flow Cannula |
| Nasal Low Flow Cannula | Active comparator | Low Flow Nasal Cannula at less than or equal to 4 liters per minute with supplemental oxygen at patient's baseline for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to High Flow Cannula at 70 liters per minute for 30 minutes Receives: Device: Nasal High Flow Cannula; Device: Nasal Low Flow Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The distance walked in meters over 6 minutes will be measured.
Measured: 30 minutes
Secondary outcomes (1)
Breathing measured by the Borg dyspnea scale
This is a patient self-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, where "0" indicated no difficulty breathing, and "10" indicates a maximal breathing difficulty.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start12 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Thoracic Society
- Responsible party
- Principal investigator, Saramaria Afanador Castiblanco, University of Miami
- Investigators
- Saramaria Afanador Castiblanco, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578156
- Sponsor's protocol ID
- 20240476
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2024
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effects of Nasal High Flow on Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT06578156
- Acronym / sponsor ID
- 20240476
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Thoracic Society
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Aug 2024 (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.
This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal High Flow Cannula | Experimental | Device: Nasal High Flow Cannula, Device: Nasal Low Flow CannulaNasal High Flow cannula at 70 liters per minute for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to Nasal Low Flow Cannula at less than or equal to 4 liters per minute with supplemental oxygen for 30 minutes |
| Nasal Low Flow Cannula | Active comparator | Device: Nasal High Flow Cannula, Device: Nasal Low Flow CannulaLow Flow Nasal Cannula at less than or equal to 4 liters per minute with supplemental oxygen at patient's baseline for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to High Flow Cannula at 70 liters per minute for 30 minutes |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to consent
- Age 18 years or older
- Diagnosis of COPD
- Ability to ambulate without assistance
- Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all
Key exclusion criteria (6 listed)
- Pregnancy
- Being on bedrest
- Inability to consent or cooperate with the study
- Using of > 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime
- Hemodynamic instability (resting heart rate > 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)
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 |
|---|---|---|
| Nasal High Flow CannulaHigh flow nasal cannula is a device that provides heated and humidified high flow gases. In-person. Depending on participant's availability, up to 6 times | Device | Nasal High Flow Cannula, Nasal Low Flow Cannula |
| Nasal Low Flow CannulaLow flow nasal cannula is a device that provides low flow gases. In-person. Depending on participant's availability, up to 6 times | Device | Nasal High Flow Cannula, Nasal Low Flow Cannula |
Primary outcome
6-minute walk test
Time frame: 30 minutes
The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The distance walked in meters over 6 minutes will be measured.
1 secondary outcome
Breathing measured by the Borg dyspnea scale
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Saramaria Afanador Castiblanco, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High Flow Cannula and Nasal Low Flow Cannula in people with COPD, run by University of Miami at 1 site in United States.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saramaria Afanador Castiblanco, M.D. (305-243-2568, saramaria.afanador@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: 30 minutes). 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 22 Jun 2026.