Nasal ObstructionPhase 2NORTOCNCT06830109
Nasal Obstruction With Oxymetazoline and Corticosteroids
A Phase 2 study testing Oxymetazoline Nasal Spray and Budesonide nasal spray in people with Nasal Obstruction, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Oxymetazoline Nasal Spray and Budesonide nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2024to 30 Dec 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females ages 18 years or older
- have a history of nasal obstruction
- have failed a trial of topical steroids (that included at least 1 month of daily use)
- ability to read, write, and understand English
- either do not desire surgery or are poor surgical candidates due to medical comorbidities.
- Patients who have had prior use of oxymetazoline or other nasal decongestants are eligible for the study but must have stopped usage 4 weeks prior to randomization.
- Must be willing to stop using any other nasal sprays, besides saline, and oral decongestants.
Who cannot join
- Any history of sinonasal mass/tumor
- Any history of nasal polyps
- a known history of chronic sinusitis
- an allergy to oxymetazoline
- or who have any medical contraindication to oxymetazoline use, such as pulmonary hypertension.
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
Washington University
St Louis, Missouri, 63110
Sara Kukuljan, 314-362-7563, kukuljas@wustl.edu
Lucas Cruz, BA, 314-362-0549, lucascruz@wustl.edu
About this study
Official title: Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids
This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.
Read the detailed description
Participants will be directed to apply the intranasal spray, at a dosage of two sprays in each nostril, twice daily. The total treatment time for participants in both trial arms is 7 weeks. Participants will be randomized to either 1) oxymetazoline + budesonide intranasal spray or 2) budesonide intranasal spray. Participants will be mailed the intranasal spray directly from the pharmacy. Participants will complete questionnaires via REDCap survey link at baseline, Week 2, Week 4, Week 5, Week 6, and Week 7. A group of 10 participants will be asked to have nasal mucosal biopsies done at baseline and between weeks 4 and 6.
- Conditions
- Nasal Obstruction
- Being tested
- Oxymetazoline Nasal Spray, Budesonide nasal spray
- Keywords
- Oxymetazoline, Corticosteroids, Chronic rhinitis
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline Nasal SprayDrug
Also called Afrin (commercial name for oxymetazoline hydrochloride)
Intra-nasal alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC)
Budesonide nasal sprayDrug
Also called Rhinocort (commercial name for budesonide)
Intranasal corticosteroid that is available over-the-counter (OTC)
| Study group | Role | What they receive |
|---|---|---|
| budesonide + oxymetazoline, | Experimental | alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC). Receives: Drug: Oxymetazoline Nasal Spray; Drug: Budesonide nasal spray |
| budesonide | Active comparator | intranasal corticosteroid that is available OTC. Receives: Drug: Budesonide nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Responders
The primary outcome measure will be the rate of responders (as a percentage) to the intervention defined as the number of participants reporting 2 (Moderately Improved), or 3 (Much Improved) in the Clinical Global Impression of Improvement (CGI-I) assessed after 4 weeks of treatment divided by the total number of participants in each study group.
CGI-I asks subjects to rate their overall response to treatment using a 7-point Likert scale ranging from -3 to 3 ("Much Worse" to "Much Improved"). Participants responding 2 (Moderately Improved), or 3 (Much Improved) to the the CGI-I question "Compared to the start of the study, how would you rate your nasal breathing now", will be defined as responders to treatment.
Measured: 4 weeks
Secondary outcomes (3)
Sino-Nasal Outcome Test (SNOT-22)
SNOT-22 is a 22-question survey designed to measure the physical, functional, and emotional consequences of rhinosinusitis. It contains questions regarding symptoms commonly associated with sinonasal disease.
Subjects rate each question by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT-22 total score ranges from a minimum score of 0 to a maximum score of 110, with higher scores representing worse outcome.
Measured: baseline, 2 weeks, and 4 weeks
Nasal Obstruction Symptom Evaluation (NOSE)
NOSE is a disease-specific survey designed to measure nasal obstruction. It consists of 5 questions, each rated on a scale of 0 to 4. The total score represents the sum of the raw scores multiplied by 5 and ranges from 0 to 100, with higher values indicating worse symptoms. A score of 30 is considered indicative of clinically significant nasal airway obstruction.
Measured: baseline, 2 weeks, 4 weeks
Clinical Global Impression of Severity (CGI-S)
The CGI-Severity Scale from 1 to 7 (1 is "Not Obstructed at All", 7 is "Completely Obstructed") provides the severity of nasal obstruction as perceived from the patient. Comparison of CGI-S scores at 4 weeks with baseline will help identify subjects that have experienced rebound congestion. The investigators will report the number of patients who report a worsening of their symptoms, as measured by a 1-point (1 category) increase in CGI-S scale at 4 weeks as compared to CGI-S scale at baseline.
Measured: baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, double-blinded, randomized, controlled trial conducted at Washington University School of Medicine
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nyssa Farrell, Washington University School of Medicine
- Investigators
- Nyssa F Farrell, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830109
- Sponsor's protocol ID
- 202406175
- Acronym
- NORTOC
- Status last verified
- Sep 2025
- First submitted
- 11 Feb 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scarupa MD, Kaliner MA. Nonallergic rhinitis, with a focus on vasomotor rhinitis: clinical importance, differential diagnosis, and effective treatment recommendations. World Allergy Organ J. 2009 Mar;2(3):20-5. doi: 10.1097/WOX.0b013e3181990aac.
PubMed 23282951Stewart M, Ferguson B, Fromer L. Epidemiology and burden of nasal congestion. Int J Gen Med. 2010 Apr 8;3:37-45. doi: 10.2147/ijgm.s8077.
PubMed 20463822Thongngarm T, Assanasen P, Pradubpongsa P, Tantilipikorn P. The effectiveness of oxymetazoline plus intranasal steroid in the treatment of chronic rhinitis: A randomised controlled trial. Asian Pac J Allergy Immunol. 2016 Mar;34(1):30-7. doi: 10.12932/AP0649.34.1.2016.
PubMed 26994623Calvo-Henriquez C, Viera-Artiles J, Rodriguez-Iglesias M, Rodriguez-Rivas P, Maniaci A, Yanez MM, Martinez-Capoccioni G, Alobid I. The Role of Corticosteroid Nasal Irrigations in the Management of Chronic Rhinosinusitis: A State-of-the-Art Systematic Review. J Clin Med. 2023 May 22;12(10):3605. doi: 10.3390/jcm12103605.
PubMed 37240711Vaidyanathan S, Williamson P, Clearie K, Khan F, Lipworth B. Fluticasone reverses oxymetazoline-induced tachyphylaxis of response and rebound congestion. Am J Respir Crit Care Med. 2010 Jul 1;182(1):19-24. doi: 10.1164/rccm.200911-1701OC. Epub 2010 Mar 4.
PubMed 20203244Graf P, Juto JE. Decongestion effect and rebound swelling of the nasal mucosa during 4-week use of oxymetazoline. ORL J Otorhinolaryngol Relat Spec. 1994 May-Jun;56(3):157-60. doi: 10.1159/000276633.
PubMed 7515487Morris S, Eccles R, Martez SJ, Riker DK, Witek TJ. An evaluation of nasal response following different treatment regimes of oxymetazoline with reference to rebound congestion. Am J Rhinol. 1997 Mar-Apr;11(2):109-15. doi: 10.2500/105065897782537197.
PubMed 9129752Kumar RS, Jain MK, Kushwaha JS, Patil S, Patil V, Ghatak S, Sanmukhani J, Mittal R. Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion. J Asthma Allergy. 2022 Jun 10;15:783-792. doi: 10.2147/JAA.S357288. eCollection 2022.
PubMed 35712651Matreja PS, Gupta V, Kaur J, Singh S. Efficacy of fluticasone and oxymetazoline as the treatment for allergic rhinitis. J Clin Diagn Res. 2012;6(1):85-88.
Meltzer EO, Bernstein DI, Prenner BM, Berger WE, Shekar T, Teper AA. Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):102-8. doi: 10.2500/ajra.2013.27.3864.
PubMed 23562197Juvekar MR, Vaidya GK, Majumder A, Pendharkar AD, Irudhayarajan A, Kundu A, Ramesh D, Kumar JD, Jagannatha B, Mathew J, Nikam MP, Mehta M, Chawla N, Hajare P, Gowda PGC, Murthy PVLN, Mathew SM, Damle MV, Kant C, Nair AB, Jaiswal A, Mehta RT. A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis. Clin Drug Investig. 2024 Feb;44(2):123-130. doi: 10.1007/s40261-023-01338-8. Epub 2024 Jan 9.
PubMed 38195833Elwany SS, Stephanos WM. Rhinitis medicamentosa. An experimental histopathological and histochemical study. ORL J Otorhinolaryngol Relat Spec. 1983;45(4):187-94. doi: 10.1159/000275642.
PubMed 6192384Elwany S, Abdel-Salaam S. Treatment of rhinitis medicamentosa with fluticasone propionate--an experimental study. Eur Arch Otorhinolaryngol. 2001 Mar;258(3):116-9. doi: 10.1007/s004050000309.
PubMed 11374251Knipping S, Holzhausen HJ, Goetze G, Riederer A, Bloching MB. Rhinitis medicamentosa: electron microscopic changes of human nasal mucosa. Otolaryngol Head Neck Surg. 2007 Jan;136(1):57-61. doi: 10.1016/j.otohns.2006.08.025.
PubMed 17210334Lin CY, Cheng PH, Fang SY. Mucosal changes in rhinitis medicamentosa. Ann Otol Rhinol Laryngol. 2004 Feb;113(2):147-51. doi: 10.1177/000348940411300213.
PubMed 14994772
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Obstruction Randomized Trial With Oxymetazoline and Corticosteroids
- ClinicalTrials.gov ID
- NCT06830109
- Acronym / sponsor ID
- NORTOC / 202406175
- Conditions
- Nasal Obstruction
- Keywords
- Oxymetazoline, Corticosteroids, Chronic rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (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 examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.
Detailed description
Participants will be directed to apply the intranasal spray, at a dosage of two sprays in each nostril, twice daily. The total treatment time for participants in both trial arms is 7 weeks. Participants will be randomized to either 1) oxymetazoline + budesonide intranasal spray or 2) budesonide intranasal spray. Participants will be mailed the intranasal spray directly from the pharmacy. Participants will complete questionnaires via REDCap survey link at baseline, Week 2, Week 4, Week 5, Week 6, and Week 7. A group of 10 participants will be asked to have nasal mucosal biopsies done at baseline and between weeks 4 and 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-center, double-blinded, randomized, controlled trial conducted at Washington University School of Medicine
| Arm | Type | Receives |
|---|---|---|
| budesonide + oxymetazoline, | Experimental | Drug: Oxymetazoline Nasal Spray, Drug: Budesonide nasal sprayalpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC). |
| budesonide | Active comparator | Drug: Budesonide nasal sprayintranasal corticosteroid that is available OTC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- males and females ages 18 years or older
- have a history of nasal obstruction
- have failed a trial of topical steroids (that included at least 1 month of daily use)
- ability to read, write, and understand English
- either do not desire surgery or are poor surgical candidates due to medical comorbidities.
Key exclusion criteria (5 listed)
- Any history of sinonasal mass/tumor
- Any history of nasal polyps
- a known history of chronic sinusitis
- an allergy to oxymetazoline
- or who have any medical contraindication to oxymetazoline use, such as 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 |
|---|---|---|
| Oxymetazoline Nasal SprayAlso: Afrin (commercial name for oxymetazoline hydrochloride)Intra-nasal alpha-adrenergic agonist and vasoconstrictor that is available over-the-counter (OTC) | Drug | budesonide + oxymetazoline, |
| Budesonide nasal sprayAlso: Rhinocort (commercial name for budesonide)Intranasal corticosteroid that is available over-the-counter (OTC) | Drug | budesonide, budesonide + oxymetazoline, |
Primary outcome
Rate of Responders
Time frame: 4 weeks
The primary outcome measure will be the rate of responders (as a percentage) to the intervention defined as the number of participants reporting 2 (Moderately Improved), or 3 (Much Improved) in the Clinical Global Impression of Improvement (CGI-I) assessed after 4 weeks of treatment divided by the total number of participants in each study group. CGI-I asks subjects to rate their overall response to treatment using a 7-point Likert scale ranging from -3 to 3 ("Much Worse" to "Much Improved"). Participants responding 2 (Moderately Improved), or 3 (Much Improved) to the the CGI-I question "Compared to the start of the study, how would you rate your nasal breathing now", will be defined as responders to treatment.
3 secondary outcomes
Sino-Nasal Outcome Test (SNOT-22)
Time frame: baseline, 2 weeks, and 4 weeks
Nasal Obstruction Symptom Evaluation (NOSE)
Time frame: baseline, 2 weeks, 4 weeks
Clinical Global Impression of Severity (CGI-S)
Time frame: baseline, week 4
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 11 Sep 2025.
- Background: PubMed 23282951Scarupa MD, Kaliner MA. Nonallergic rhinitis, with a focus on vasomotor rhinitis: clinical importance, differential diagnosis, and effective treatment recommendations. World Allergy Organ J. 2009 Mar;2(3):20-5. doi: 10.1097/WOX.0b013e3181990aac.
- Background: PubMed 20463822Stewart M, Ferguson B, Fromer L. Epidemiology and burden of nasal congestion. Int J Gen Med. 2010 Apr 8;3:37-45. doi: 10.2147/ijgm.s8077.
- Background: PubMed 26994623Thongngarm T, Assanasen P, Pradubpongsa P, Tantilipikorn P. The effectiveness of oxymetazoline plus intranasal steroid in the treatment of chronic rhinitis: A randomised controlled trial. Asian Pac J Allergy Immunol. 2016 Mar;34(1):30-7. doi: 10.12932/AP0649.34.1.2016.
- Background: PubMed 37240711Calvo-Henriquez C, Viera-Artiles J, Rodriguez-Iglesias M, Rodriguez-Rivas P, Maniaci A, Yanez MM, Martinez-Capoccioni G, Alobid I. The Role of Corticosteroid Nasal Irrigations in the Management of Chronic Rhinosinusitis: A State-of-the-Art Systematic Review. J Clin Med. 2023 May 22;12(10):3605. doi: 10.3390/jcm12103605.
- Background: PubMed 20203244Vaidyanathan S, Williamson P, Clearie K, Khan F, Lipworth B. Fluticasone reverses oxymetazoline-induced tachyphylaxis of response and rebound congestion. Am J Respir Crit Care Med. 2010 Jul 1;182(1):19-24. doi: 10.1164/rccm.200911-1701OC. Epub 2010 Mar 4.
- Background: PubMed 7515487Graf P, Juto JE. Decongestion effect and rebound swelling of the nasal mucosa during 4-week use of oxymetazoline. ORL J Otorhinolaryngol Relat Spec. 1994 May-Jun;56(3):157-60. doi: 10.1159/000276633.
- Background: PubMed 9129752Morris S, Eccles R, Martez SJ, Riker DK, Witek TJ. An evaluation of nasal response following different treatment regimes of oxymetazoline with reference to rebound congestion. Am J Rhinol. 1997 Mar-Apr;11(2):109-15. doi: 10.2500/105065897782537197.
- Background: PubMed 35712651Kumar RS, Jain MK, Kushwaha JS, Patil S, Patil V, Ghatak S, Sanmukhani J, Mittal R. Efficacy and Safety of Fluticasone Furoate and Oxymetazoline Nasal Spray: A Novel First Fixed Dose Combination for the Management of Allergic Rhinitis with Nasal Congestion. J Asthma Allergy. 2022 Jun 10;15:783-792. doi: 10.2147/JAA.S357288. eCollection 2022.
- BackgroundMatreja PS, Gupta V, Kaur J, Singh S. Efficacy of fluticasone and oxymetazoline as the treatment for allergic rhinitis. J Clin Diagn Res. 2012;6(1):85-88.
- Background: PubMed 23562197Meltzer EO, Bernstein DI, Prenner BM, Berger WE, Shekar T, Teper AA. Mometasone furoate nasal spray plus oxymetazoline nasal spray: short-term efficacy and safety in seasonal allergic rhinitis. Am J Rhinol Allergy. 2013 Mar-Apr;27(2):102-8. doi: 10.2500/ajra.2013.27.3864.
- Background: PubMed 38195833Juvekar MR, Vaidya GK, Majumder A, Pendharkar AD, Irudhayarajan A, Kundu A, Ramesh D, Kumar JD, Jagannatha B, Mathew J, Nikam MP, Mehta M, Chawla N, Hajare P, Gowda PGC, Murthy PVLN, Mathew SM, Damle MV, Kant C, Nair AB, Jaiswal A, Mehta RT. A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis. Clin Drug Investig. 2024 Feb;44(2):123-130. doi: 10.1007/s40261-023-01338-8. Epub 2024 Jan 9.
- Background: PubMed 6192384Elwany SS, Stephanos WM. Rhinitis medicamentosa. An experimental histopathological and histochemical study. ORL J Otorhinolaryngol Relat Spec. 1983;45(4):187-94. doi: 10.1159/000275642.
- 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.
Nyssa F Farrell, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxymetazoline Nasal Spray and Budesonide nasal spray in people with Nasal Obstruction, run by Washington University School of Medicine 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 7 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: looking for participants now, as of the sponsor's last update on 11 Sep 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nyssa Farrell, MD (314-362-7509, nyssa.farrell@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Responders (time frame: 4 weeks). 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 NCT06830109, which also lists 29 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 11 Sep 2025.