Chronic Obstructive Pulmonary Disease (COPD)NHFlOscilloNCT07750613
Time Course of Respiratory Oscillometry Parameters During Nasal High-Flow Therapy in Stable Chronic Obstructive Pulmonary Disease
A study testing Heated Humidified Nasal High-Flow Therapy in people with Chronic Obstructive Pulmonary Disease (COPD), run by ADIR Association at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) can affect the small airways and alter respiratory mechanics. Nasal high-flow therapy delivers warmed and humidified gas through nasal cannulas and may change airway resistance. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Heated Humidified Nasal High-Flow Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 29 Feb 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and <85 years;
- Chronic obstructive pulmonary disease classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric grade III or IV;
- Modified Medical Research Council dyspnea score ≥2;
- Completed a pulmonary rehabilitation program at the study center;
- Clinically stable, defined as no exacerbation and no treatment change during the previous 4 weeks;
- With or without long-term oxygen therapy;
Show all 16Show fewer
- Never previously used nasal high-flow therapy;
- Affiliated with a French social security system;
- Able to read and understand the participant information and provide written informed consent.
- Non-inclusion Criteria:
- Under legal guardianship or curatorship;
- Confirmed or suspected pregnancy;
- Unable to provide informed consent;
- Primary diagnosis of another chronic obstructive respiratory disease, such as asthma or primary bronchiectasis;
- Severe or unstable cardiovascular disease, including uncontrolled cardiac arrhythmia, severe heart failure, recent myocardial infarction, or unstable angina;
- Hemodynamic instability.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
ADIR Association
Rouen, Normandy, 76000
Tristan Bonnevie, PhD, +33235592970, t.bonnevie@adir-hautenormandie.com
Tristan Bonnevie, PhD
About this study
Official title: Time Course of Respiratory Oscillometry Parameters During Exposure to Nasal High-Flow Therapy in People With Stable Chronic Obstructive Pulmonary Disease: A Prospective Open-Label Single-Arm Physiological Study
Chronic obstructive pulmonary disease (COPD) can affect the small airways and alter respiratory mechanics. Nasal high-flow therapy delivers warmed and humidified gas through nasal cannulas and may change airway resistance. Respiratory oscillometry is a noninvasive test that measures respiratory resistance and reactance during quiet breathing.
This prospective, single-center study will enroll 20 adults with severe or very severe stable COPD who have never used nasal high-flow therapy. During a single study visit lasting approximately 6 hours, participants will receive individualized nasal high-flow therapy for 4 hours. Respiratory oscillometry will be measured before exposure, immediately after device titration, and after 30, 60, 120, 180, and 240 minutes.
The primary objective is to describe the time course of the difference between respiratory resistance measured at 5 hertz and at 20 hertz (R5-R20), an indirect index of peripheral airway mechanical abnormalities. Secondary objectives are to describe changes in total and proximal respiratory resistance, respiratory reactance, resonant frequency, and area of reactance. The hypothesis is that nasal high-flow exposure will produce measurable, time-dependent changes in respiratory oscillometry parameters.
Read the detailed description
NHFlOscillo is a prospective, open-label, single-center, single-arm physiological study involving adults with stable severe to very severe chronic obstructive pulmonary disease (COPD). The study is designed to characterize the time course of respiratory oscillometry parameters during a standardized 4-hour exposure to heated and humidified nasal high-flow therapy.
Participants will attend a single study visit and will be instructed to take their usual medications before the visit. After providing written informed consent, baseline characteristics will be recorded, and participants will complete the modified Medical Research Council Dyspnea Scale (mMRC), the St George's Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT), and the Leicester Cough Questionnaire (LCQ). Baseline impulse oscillometry (IOS) will then be performed using a calibrated Vyntus IOS system, with the participant seated and breathing quietly, in accordance with current European Respiratory Society technical standards.
Nasal high-flow therapy will be initiated at a flow rate of 15 L/min and a temperature of 34 °C. After 3 minutes, the temperature will be increased to 37 °C if tolerated; otherwise, it will be maintained at 34 °C. The flow rate will then be increased every 3 minutes to an individualized level consistent with usual clinical practice, up to a maximum of 40 L/min. In participants receiving long-term oxygen therapy, supplemental oxygen will be titrated to maintain an oxygen saturation comparable to that observed under their usual conditions without nasal high-flow therapy.
The exposure will be continued for a total of 4 hours and will be briefly interrupted to perform oscillometry measurements immediately after titration and at 30, 60, 120, 180, and 240 minutes after the start of nasal high-flow therapy.
The target sample size is 20 participants. Changes in oscillometry parameters over time will be analyzed using linear mixed-effects models, with measurement time included as a fixed effect and participant included as a random effect. Each post-exposure time point will be compared with the pre-exposure baseline. Results will be reported as mean differences with 95% confidence intervals and interpreted according to the minimal clinically important difference for each outcome, when available.
Prespecified subgroup analyses will be conducted in participants receiving long-term oxygen therapy and in participants with cough and sputum production. Cough and sputum production will be identified using two alternative operational definitions:
CAT: a score ≥2 on both items 1 and 2; SGRQ: cough on most days or several days per week (response option 1 or 2 to the item "I cough") and sputum production on most days or several days per week (response option 1 or 2 to the item "I bring up sputum").
- Being tested
- Heated Humidified Nasal High-Flow Therapy
- Keywords
- Nasal high-flow therapy, High-flow nasal cannula, Respiratory oscillometry, Impulse oscillometry, Small airways, Respiratory mechanics
- 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.
Heated Humidified Nasal High-Flow TherapyDevice
Therapy is initiated at 15 L/min and 34 °C. After 3 minutes, the temperature is increased to 37 °C if tolerated; otherwise it is returned to or maintained at 34 °C. Flow is increased every 3 minutes to an individualized clinically used level, up to 40 L/min. In participants receiving long-term oxygen therapy, supplemental oxygen is titrated to maintain a saturation comparable to the usual saturation without nasal high-flow therapy. Total exposure duration is 4 hours. The intervention is briefly interrupted for respiratory oscillometry immediately after titration and at 30, 60, 120, 180, and 240 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nasal High-Flow Therapy | Experimental | Participants receive individualized, heated and humidified nasal high-flow therapy (myAirvo 3, Fisher \& Paykel Healthcare, New Zealand) for 4 hours during a single study visit, with repeated respiratory oscillometry assessments. Receives: Device: Heated Humidified Nasal High-Flow Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Frequency Dependence of Respiratory Resistance (R5-R20)
Frequency dependence of respiratory resistance is calculated as respiratory resistance measured at 5 hertz minus respiratory resistance measured at 20 hertz (R5-R20). It is measured by impulse oscillometry using the Vyntus impulse oscillometry system (IOS) and expressed in kilopascals per liter per second (kPa/L/s). Percent-predicted values will also be reported when appropriate reference equations are available. The outcome is the change from the pre-exposure baseline at each post-baseline assessment during the exposure period. The registered measure is the repeated change from the pre-exposure baseline across the exposure period.
Measured: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Secondary outcomes (5)
Change From Baseline in Total Respiratory Resistance at 5 Hertz (R5)
Total respiratory resistance at 5 hertz (R5) is measured by impulse oscillometry and expressed in kPa/L/s. Percentage of predicted values will also be reported when reference equations are available.
Measured: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Proximal Respiratory Resistance at 20 Hertz (R20)
Respiratory resistance at 20 hertz (R20), reflecting predominantly proximal airway resistance, is measured by impulse oscillometry and expressed in kPa/L/s. Percentage of predicted values will also be reported when reference equations are available.
Measured: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Respiratory Reactance at 5 Hertz (X5)
Respiratory reactance at 5 hertz (X5) is measured by impulse oscillometry and expressed in kPa/L/s. Percentage of predicted values will also be reported when reference equations are available.
Measured: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Resonant Frequency (Fres)
Resonant frequency (Fres) is measured by impulse oscillometry and expressed in hertz. Percentage of predicted values will also be reported when reference equations are available.
Measured: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Area of Reactance (AX)
Area of reactance (AX) is measured by impulse oscillometry and expressed in kPa/L. Percentage of predicted values will also be reported when reference equations are available.
Measured: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same 4-hour exposure to individualized, heated, humidified nasal high-flow therapy. Repeated respiratory oscillometry measurements are obtained before and during exposure to characterize time-dependent physiological changes.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rouen Normandie, Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Tristan Bonnevie, PhD, Principal investigator, ADIR Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750613
- Sponsor's protocol ID
- NHFlOscillo
- Acronym
- NHFlOscillo
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request for research purposes after publication. This includes de-identified data related to demographic characteristics, as well as endpoints published either in the main manuscript or any supplemental data. Requests should be sent to t.bonnevie@adir-hautenormandie.com
Publications
Abdo M, Kirsten AM, von Mutius E, Kopp M, Hansen G, Rabe KF, Watz H, Trinkmann F, Bahmer T; ALLIANCE study group. Minimal clinically important difference for impulse oscillometry in adults with asthma. Eur Respir J. 2023 May 5;61(5):2201793. doi: 10.1183/13993003.01793-2022. Print 2023 May.
PubMed 36758985Kuo YL, Chien CL, Ko HK, Lai HC, Lin TL, Lee LN, Chang CY, Shen HS, Lu CC. High-flow nasal cannula improves respiratory impedance evaluated by impulse oscillometry in chronic obstructive pulmonary disease patients: a randomised controlled trial. Sci Rep. 2022 Apr 28;12(1):6981. doi: 10.1038/s41598-022-10873-x.
PubMed 35484186
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course of Respiratory Oscillometry Parameters During Exposure to Nasal High-Flow Therapy in People With Stable Chronic Obstructive Pulmonary Disease: A Prospective Open-Label Single-Arm Physiological Study
- ClinicalTrials.gov ID
- NCT07750613
- Acronym / sponsor ID
- NHFlOscillo / NHFlOscillo
- Keywords
- Nasal high-flow therapy, High-flow nasal cannula, Respiratory oscillometry, Impulse oscillometry, Small airways, Respiratory mechanics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Collaborators
- University of Rouen Normandie, Fisher and Paykel Healthcare
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 6 Aug 2026 (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.
Chronic obstructive pulmonary disease (COPD) can affect the small airways and alter respiratory mechanics. Nasal high-flow therapy delivers warmed and humidified gas through nasal cannulas and may change airway resistance. Respiratory oscillometry is a noninvasive test that measures respiratory resistance and reactance during quiet breathing.
This prospective, single-center study will enroll 20 adults with severe or very severe stable COPD who have never used nasal high-flow therapy. During a single study visit lasting approximately 6 hours, participants will receive individualized nasal high-flow therapy for 4 hours. Respiratory oscillometry will be measured before exposure, immediately after device titration, and after 30, 60, 120, 180, and 240 minutes.
The primary objective is to describe the time course of the difference between respiratory resistance measured at 5 hertz and at 20 hertz (R5-R20), an indirect index of peripheral airway mechanical abnormalities. Secondary objectives are to describe changes in total and proximal respiratory resistance, respiratory reactance, resonant frequency, and area of reactance. The hypothesis is that nasal high-flow exposure will produce measurable, time-dependent changes in respiratory oscillometry parameters.
Detailed description
NHFlOscillo is a prospective, open-label, single-center, single-arm physiological study involving adults with stable severe to very severe chronic obstructive pulmonary disease (COPD). The study is designed to characterize the time course of respiratory oscillometry parameters during a standardized 4-hour exposure to heated and humidified nasal high-flow therapy.
Participants will attend a single study visit and will be instructed to take their usual medications before the visit. After providing written informed consent, baseline characteristics will be recorded, and participants will complete the modified Medical Research Council Dyspnea Scale (mMRC), the St George's Respiratory Questionnaire (SGRQ), the COPD Assessment Test (CAT), and the Leicester Cough Questionnaire (LCQ). Baseline impulse oscillometry (IOS) will then be performed using a calibrated Vyntus IOS system, with the participant seated and breathing quietly, in accordance with current European Respiratory Society technical standards.
Nasal high-flow therapy will be initiated at a flow rate of 15 L/min and a temperature of 34 °C. After 3 minutes, the temperature will be increased to 37 °C if tolerated; otherwise, it will be maintained at 34 °C. The flow rate will then be increased every 3 minutes to an individualized level consistent with usual clinical practice, up to a maximum of 40 L/min. In participants receiving long-term oxygen therapy, supplemental oxygen will be titrated to maintain an oxygen saturation comparable to that observed under their usual conditions without nasal high-flow therapy.
The exposure will be continued for a total of 4 hours and will be briefly interrupted to perform oscillometry measurements immediately after titration and at 30, 60, 120, 180, and 240 minutes after the start of nasal high-flow therapy.
The target sample size is 20 participants. Changes in oscillometry parameters over time will be analyzed using linear mixed-effects models, with measurement time included as a fixed effect and participant included as a random effect. Each post-exposure time point will be compared with the pre-exposure baseline. Results will be reported as mean differences with 95% confidence intervals and interpreted according to the minimal clinically important difference for each outcome, when available.
Prespecified subgroup analyses will be conducted in participants receiving long-term oxygen therapy and in participants with cough and sputum production. Cough and sputum production will be identified using two alternative operational definitions:
CAT: a score ≥2 on both items 1 and 2; SGRQ: cough on most days or several days per week (response option 1 or 2 to the item "I cough") and sputum production on most days or several days per week (response option 1 or 2 to the item "I bring up sputum").
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same 4-hour exposure to individualized, heated, humidified nasal high-flow therapy. Repeated respiratory oscillometry measurements are obtained before and during exposure to characterize time-dependent physiological changes.
| Arm | Type | Receives |
|---|---|---|
| Nasal High-Flow Therapy | Experimental | Device: Heated Humidified Nasal High-Flow TherapyParticipants receive individualized, heated and humidified nasal high-flow therapy (myAirvo 3, Fisher \& Paykel Healthcare, New Zealand) for 4 hours during a single study visit, with repeated respiratory oscillometry assessments. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age >18 years and <85 years;
- Chronic obstructive pulmonary disease classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric grade III or IV;
- Modified Medical Research Council dyspnea score ≥2;
- Completed a pulmonary rehabilitation program at the study center;
- Clinically stable, defined as no exacerbation and no treatment change during the previous 4 weeks;
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Heated Humidified Nasal High-Flow TherapyTherapy is initiated at 15 L/min and 34 °C. After 3 minutes, the temperature is increased to 37 °C if tolerated; otherwise it is returned to or maintained at 34 °C. Flow is increased every 3 minutes to an individualized clinically used level, up to 40 L/min. In participants receiving long-term oxygen therapy, supplemental oxygen is titrated to maintain a saturation comparable to the usual saturation without nasal high-flow therapy. Total exposure duration is 4 hours. The intervention is briefly interrupted for respiratory oscillometry immediately after titration and at 30, 60, 120, 180, and 240 minutes. | Device | Nasal High-Flow Therapy |
Primary outcome
Change From Baseline in Frequency Dependence of Respiratory Resistance (R5-R20)
Time frame: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Frequency dependence of respiratory resistance is calculated as respiratory resistance measured at 5 hertz minus respiratory resistance measured at 20 hertz (R5-R20). It is measured by impulse oscillometry using the Vyntus impulse oscillometry system (IOS) and expressed in kilopascals per liter per second (kPa/L/s). Percent-predicted values will also be reported when appropriate reference equations are available. The outcome is the change from the pre-exposure baseline at each post-baseline assessment during the exposure period. The registered measure is the repeated change from the pre-exposure baseline across the exposure period.
5 secondary outcomes
Change From Baseline in Total Respiratory Resistance at 5 Hertz (R5)
Time frame: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Proximal Respiratory Resistance at 20 Hertz (R20)
Time frame: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Respiratory Reactance at 5 Hertz (X5)
Time frame: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Resonant Frequency (Fres)
Time frame: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
Change From Baseline in Area of Reactance (AX)
Time frame: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.
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 10 Aug 2026.
- Background: PubMed 36758985Abdo M, Kirsten AM, von Mutius E, Kopp M, Hansen G, Rabe KF, Watz H, Trinkmann F, Bahmer T; ALLIANCE study group. Minimal clinically important difference for impulse oscillometry in adults with asthma. Eur Respir J. 2023 May 5;61(5):2201793. doi: 10.1183/13993003.01793-2022. Print 2023 May.
- Background: PubMed 35484186Kuo YL, Chien CL, Ko HK, Lai HC, Lin TL, Lee LN, Chang CY, Shen HS, Lu CC. High-flow nasal cannula improves respiratory impedance evaluated by impulse oscillometry in chronic obstructive pulmonary disease patients: a randomised controlled trial. Sci Rep. 2022 Apr 28;12(1):6981. doi: 10.1038/s41598-022-10873-x.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request for research purposes after publication. This includes de-identified data related to demographic characteristics, as well as endpoints published either in the main manuscript or any supplemental data. Requests should be sent to t.bonnevie@adir-hautenormandie.com
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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.
Tristan Bonnevie, PhD principal investigator
ADIR Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heated Humidified Nasal High-Flow Therapy in people with Chronic Obstructive Pulmonary Disease (COPD), run by ADIR Association at 1 site in France.
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 16 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Aug 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 France. 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 Tristan Bonnevie, PhD (+33235592970, t.bonnevie@adir-hautenormandie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Frequency Dependence of Respiratory Resistance (R5-R20) (time frame: Baseline; immediately after individualized nasal high-flow titration; and 30, 60, 120, 180, and 240 minutes after starting nasal high-flow therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07750613, which also lists 2 linked publications.
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 10 Aug 2026.