Nontuberculous Mycobacterial Lung DiseaseHiNTMNCT07647575
Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
A study testing Nebulized 3% Hypertonic Saline and Nebulized Normal Saline in people with Nontuberculous Mycobacterial Lung Disease and Bronchiectasis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nontuberculous Mycobacterial Lung Disease, Bronchiectasis
- What is being tested?
- Nebulized 3% Hypertonic Saline and Nebulized Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Oct 2025to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Diagnosis of nontuberculous mycobacterial lung disease (NTM-LD) according to ATS/ERS/ESCMID/IDSA diagnostic criteria, including compatible clinical symptoms, radiographic findings, and microbiological evidence.
- Not receiving anti-NTM antibiotic treatment at the time of screening.
- Able and willing to provide written informed consent.
- Able to perform nebulized inhalation therapy using a mesh nebulizer at home.
Who cannot join
- Active tuberculosis.
- Human immunodeficiency virus (HIV) infection.
- Receiving active treatment for malignancy.
- Uncontrolled asthma.
- Frequent or clinically significant hemoptysis.
- History of intolerance, bronchospasm, or hypersensitivity during inhalation testing with hypertonic saline.
- Inability to prepare a mesh nebulizer or perform inhalation therapy at home.
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Sheng-Wei Pan, MD, PhD, +886-2-28757456, swpan2@vghtpe.gov.tw
About this study
Official title: A Randomized Controlled Trial of Early Versus Delayed Hypertonic Saline Inhalation in Treatment-Naïve Nontuberculous Mycobacterial Lung Disease
This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD). Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline for 6 months or delayed initiation consisting of normal saline inhalation during the first 3 months followed by 3% hypertonic saline during the subsequent 3 months.
The primary objective is to compare respiratory symptom improvement between hypertonic saline and normal saline at Month 3. Secondary objectives include evaluating sputum microbiological outcomes, radiographic changes, inflammatory markers, small airway function, treatment initiation, safety, and within-participant changes before and after switching from normal saline to hypertonic saline in the delayed-initiation arm.
The first participant was enrolled on October 3, 2025.
Read the detailed description
Nontuberculous mycobacterial lung disease (NTM-LD) is a chronic pulmonary infection that frequently progresses despite conservative management. Because prolonged multidrug antibiotic therapy is associated with substantial treatment burden, potential toxicity, and variable effectiveness, additional non-antibiotic treatment strategies are needed, particularly for patients who defer, cannot tolerate, or are not yet indicated for antibiotic treatment.
Hypertonic saline inhalation facilitates airway clearance and sputum removal and has been increasingly used as an adjunctive treatment in specialized NTM centers. However, prospective randomized data remain limited, particularly in Asian populations.
This multicenter randomized controlled trial investigates whether early initiation of inhaled 3% hypertonic saline improves respiratory symptoms and microbiological outcomes compared with delayed initiation.
To ensure treatment safety, all participants undergo a supervised inhalation tolerance assessment before randomization. During this assessment, inhaled salbutamol (Ventolin) premedication is administered, followed by inhalation of 3% hypertonic saline. Participants demonstrating clinically significant intolerance, severe bronchospasm, or other safety concerns are excluded from study treatment.
Following successful completion of the tolerance assessment, participants are randomized to one of two groups.
The early-initiation group receives inhaled 3% hypertonic saline for 6 months. The delayed-initiation group receives inhaled normal saline during Months 0-3, followed by inhaled 3% hypertonic saline during Months 4-6.
The primary randomized comparison is performed at Month 3 between participants receiving hypertonic saline and those receiving normal saline. Additional analyses evaluate within-participant changes in the delayed-initiation arm before and after switching from normal saline to hypertonic saline.
Throughout the study, participants continue routine clinical care. Initiation of anti-NTM antibiotic treatment remains at the discretion of the treating physician.
- Being tested
- Nebulized 3% Hypertonic Saline, Nebulized Normal Saline
- Keywords
- Hypertonic saline inhalation, Airway clearance therapy, Nontuberculous Mycobacterial Lung Disease, Bronchiectasis, Mycobacterium avium complex, Mycobacterium abscessus, Respiratory Severity Score, Nebulized Hypertonic Saline, NTM-LD
- Medical subject headings
- Bronchiectasis, Mycobacterium avium-intracellulare Infection, Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized 3% Hypertonic SalineDrug
Nebulized 3% hypertonic saline, 5 mL once daily via mesh nebulizer. Administered during Months 0-6 in the early-initiation arm and during Months 4-6 in the delayed-initiation arm after completion of the Month 3 assessment.
Nebulized Normal SalineDrug
Nebulized 0.9% normal saline, 5 mL once daily via mesh nebulizer during Months 0-3 in the delayed-initiation arm.
| Study group | Role | What they receive |
|---|---|---|
| Early Hypertonic Saline Initiation | Experimental | Participants receive nebulized 3% hypertonic saline (5 mL once daily via mesh nebulizer) for 6 months in addition to standard clinical care. Anti-NTM antibiotic treatment may be initiated at the discretion of the treating physician according to clinical indications. Receives: Drug: Nebulized 3% Hypertonic Saline |
| Delayed Hypertonic Saline Initiation | Active comparator | Participants receive nebulized normal saline (5 mL once daily via mesh nebulizer) during Months 0-3, followed by nebulized 3% hypertonic saline during Months 4-6, in addition to standard clinical care. Anti-NTM antibiotic treatment may be initiated at the discretion of the treating physician according to clinical indications. Receives: Drug: Nebulized 3% Hypertonic Saline; Drug: Nebulized Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Respiratory Severity Score (RSS) From Baseline to Month 3
Total Respiratory Severity Score (RSS) ranges from 0 to 60 and is calculated from six visual analog scales evaluating cough, sputum production, dyspnea, fatigue, sleep disturbance, and overall respiratory symptoms. Higher scores indicate worse symptoms.
Measured: Baseline and Month 3
Secondary outcomes (11)
Change in Acid-Fast Bacilli (AFB) Sputum Smear Grade Over Time
AFB sputum smear grade assessed using standard semi-quantitative microscopy (negative, scanty, 1+, 2+, 3+, or 4+) at Baseline, Month 3, and Month 6. Changes in smear grade and the proportion of participants achieving smear negativity will be evaluated.
Measured: Baseline, Month 3, and Month 6
Change in Mycobacterial Sputum Culture Status Over Time
Sputum culture status assessed as positive or negative for nontuberculous mycobacteria using standard mycobacterial culture methods at Baseline, Month 3, and Month 6. Culture conversion is defined as a change from positive at baseline to negative at follow-up assessments.
Measured: Baseline, Month 3, and Month 6
Change in Radiographic Severity Score From Baseline to Month 6
Radiographic Severity Score assessed using a chest radiographic scoring system. Each lung is divided into three areas. The extent of infiltration in each area is scored from 0 to 3, resulting in a total score ranging from 0 to 18. Higher scores indicate more extensive pulmonary disease.
Measured: Baseline and Month 6
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Month 6
Erythrocyte sedimentation rate (ESR) will be measured using a standard clinical laboratory assay. Higher values indicate greater systemic inflammation.
Measured: Baseline and Month 6
Change in R5-R20 Measured by Impulse Oscillometry From Baseline to Month 6
R5-R20 measured by impulse oscillometry (IOS). R5 represents total airway resistance and R20 represents central airway resistance. The difference between R5 and R20 (R5-R20) reflects small airway dysfunction. Higher values indicate greater small airway impairment.
Measured: Baseline and Month 6
Change in Post-Bronchodilator FEV1 (% Predicted) From Baseline to Month 6
Post-bronchodilator forced expiratory volume in one second (FEV1), expressed as percent predicted, measured using standardized spirometry according to ATS/ERS recommendations. Higher values indicate better lung function.
Measured: Baseline and Month 6
Anti-NTM Treatment Initiation
Proportion of Participants Requiring Anti-NTM Antibiotic Treatment
Measured: Up to Month 6
Adverse Events
Incidence of Adverse Events Related to Hypertonic Saline Inhalation
Measured: Up to Month 6
Within-Participant Change in Respiratory Severity Score During Normal Saline and Hypertonic Saline Treatment Periods in the Delayed-Initiation Arm
Comparison of RSS change during Months 0-3 while receiving nebulized normal saline and during Months 4-6 while receiving nebulized 3% hypertonic saline in participants assigned to the delayed-initiation arm.
Measured: Baseline to Month 6
Change in Respiratory Severity Score From Month 3 to Month 6 in the Early-Initiation Arm
Evaluation of continued symptom improvement after the initial 3 months of hypertonic saline treatment.
Measured: Month 3 and Month 6
Change in Total RSS at Month 6
Total RSS ranges from 0 to 60 and is calculated from six visual analog scales evaluating cough, sputum production, dyspnea, fatigue, sleep disturbance, and overall respiratory symptoms. Higher scores indicate worse symptoms.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start3 Oct 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 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 Nontuberculous Mycobacterial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline inhalation for 6 months or delayed initiation consisting of normal saline inhalation during Months 0-3 followed by 3% hypertonic saline during Months 4-6. The primary comparison is performed at Month 3 between the two parallel groups.
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Sheng-Wei Pan, Taipei Veterans General Hospital, Taiwan
- Investigators
- Sheng-Wei Pan, MD, PhD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647575
- Sponsor's protocol ID
- HiNTM-01
- Other IDs
- 114-2314-B-075 -079, 2025-02-019A
- Acronym
- HiNTM
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huiberts A, Zweijpfenning SMH, Pennings LJ, Boeree MJ, van Ingen J, Magis-Escurra C, Hoefsloot W. Outcomes of hypertonic saline inhalation as a treatment modality in nontuberculous mycobacterial pulmonary disease. Eur Respir J. 2019 Jul 11;54(1):1802143. doi: 10.1183/13993003.02143-2018. Print 2019 Jul. No abstract available.
PubMed 31000680Daley CL, Iaccarino JM, Lange C, Cambau E, Wallace RJ Jr, Andrejak C, Bottger EC, Brozek J, Griffith DE, Guglielmetti L, Huitt GA, Knight SL, Leitman P, Marras TK, Olivier KN, Santin M, Stout JE, Tortoli E, van Ingen J, Wagner D, Winthrop KL. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline. Clin Infect Dis. 2020 Aug 14;71(4):e1-e36. doi: 10.1093/cid/ciaa241.
PubMed 32628747
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Early Versus Delayed Hypertonic Saline Inhalation in Treatment-Naïve Nontuberculous Mycobacterial Lung Disease
- ClinicalTrials.gov ID
- NCT07647575
- Acronym / sponsor ID
- HiNTM / HiNTM-01
- Keywords
- Hypertonic saline inhalation, Airway clearance therapy, Nontuberculous Mycobacterial Lung Disease, Bronchiectasis, Mycobacterium avium complex, Mycobacterium abscessus, Respiratory Severity Score, Nebulized Hypertonic Saline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 15 Jun 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.
This multicenter randomized controlled trial evaluates the clinical and microbiological effects of inhaled 3% hypertonic saline in treatment-naïve patients with nontuberculous mycobacterial lung disease (NTM-LD). Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline for 6 months or delayed initiation consisting of normal saline inhalation during the first 3 months followed by 3% hypertonic saline during the subsequent 3 months.
The primary objective is to compare respiratory symptom improvement between hypertonic saline and normal saline at Month 3. Secondary objectives include evaluating sputum microbiological outcomes, radiographic changes, inflammatory markers, small airway function, treatment initiation, safety, and within-participant changes before and after switching from normal saline to hypertonic saline in the delayed-initiation arm.
The first participant was enrolled on October 3, 2025.
Detailed description
Nontuberculous mycobacterial lung disease (NTM-LD) is a chronic pulmonary infection that frequently progresses despite conservative management. Because prolonged multidrug antibiotic therapy is associated with substantial treatment burden, potential toxicity, and variable effectiveness, additional non-antibiotic treatment strategies are needed, particularly for patients who defer, cannot tolerate, or are not yet indicated for antibiotic treatment.
Hypertonic saline inhalation facilitates airway clearance and sputum removal and has been increasingly used as an adjunctive treatment in specialized NTM centers. However, prospective randomized data remain limited, particularly in Asian populations.
This multicenter randomized controlled trial investigates whether early initiation of inhaled 3% hypertonic saline improves respiratory symptoms and microbiological outcomes compared with delayed initiation.
To ensure treatment safety, all participants undergo a supervised inhalation tolerance assessment before randomization. During this assessment, inhaled salbutamol (Ventolin) premedication is administered, followed by inhalation of 3% hypertonic saline. Participants demonstrating clinically significant intolerance, severe bronchospasm, or other safety concerns are excluded from study treatment.
Following successful completion of the tolerance assessment, participants are randomized to one of two groups.
The early-initiation group receives inhaled 3% hypertonic saline for 6 months. The delayed-initiation group receives inhaled normal saline during Months 0-3, followed by inhaled 3% hypertonic saline during Months 4-6.
The primary randomized comparison is performed at Month 3 between participants receiving hypertonic saline and those receiving normal saline. Additional analyses evaluate within-participant changes in the delayed-initiation arm before and after switching from normal saline to hypertonic saline.
Throughout the study, participants continue routine clinical care. Initiation of anti-NTM antibiotic treatment remains at the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to either early initiation of 3% hypertonic saline inhalation for 6 months or delayed initiation consisting of normal saline inhalation during Months 0-3 followed by 3% hypertonic saline during Months 4-6. The primary comparison is performed at Month 3 between the two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Early Hypertonic Saline Initiation | Experimental | Drug: Nebulized 3% Hypertonic SalineParticipants receive nebulized 3% hypertonic saline (5 mL once daily via mesh nebulizer) for 6 months in addition to standard clinical care. Anti-NTM antibiotic treatment may be initiated at the discretion of the treating physician according to clinical indications. |
| Delayed Hypertonic Saline Initiation | Active comparator | Drug: Nebulized 3% Hypertonic Saline, Drug: Nebulized Normal SalineParticipants receive nebulized normal saline (5 mL once daily via mesh nebulizer) during Months 0-3, followed by nebulized 3% hypertonic saline during Months 4-6, in addition to standard clinical care. Anti-NTM antibiotic treatment may be initiated at the discretion of the treating physician according to clinical indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Diagnosis of nontuberculous mycobacterial lung disease (NTM-LD) according to ATS/ERS/ESCMID/IDSA diagnostic criteria, including compatible clinical symptoms, radiographic findings, and microbiological evidence.
- Not receiving anti-NTM antibiotic treatment at the time of screening.
- Able and willing to provide written informed consent.
- Able to perform nebulized inhalation therapy using a mesh nebulizer at home.
Key exclusion criteria (8 listed)
- Active tuberculosis.
- Human immunodeficiency virus (HIV) infection.
- Receiving active treatment for malignancy.
- Uncontrolled asthma.
- Frequent or clinically significant hemoptysis.
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 |
|---|---|---|
| Nebulized 3% Hypertonic SalineNebulized 3% hypertonic saline, 5 mL once daily via mesh nebulizer. Administered during Months 0-6 in the early-initiation arm and during Months 4-6 in the delayed-initiation arm after completion of the Month 3 assessment. | Drug | Delayed Hypertonic Saline Initiation, Early Hypertonic Saline Initiation |
| Nebulized Normal SalineNebulized 0.9% normal saline, 5 mL once daily via mesh nebulizer during Months 0-3 in the delayed-initiation arm. | Drug | Delayed Hypertonic Saline Initiation |
Primary outcome
Change in Total Respiratory Severity Score (RSS) From Baseline to Month 3
Time frame: Baseline and Month 3
Total Respiratory Severity Score (RSS) ranges from 0 to 60 and is calculated from six visual analog scales evaluating cough, sputum production, dyspnea, fatigue, sleep disturbance, and overall respiratory symptoms. Higher scores indicate worse symptoms.
11 secondary outcomes
Change in Acid-Fast Bacilli (AFB) Sputum Smear Grade Over Time
Time frame: Baseline, Month 3, and Month 6
Change in Mycobacterial Sputum Culture Status Over Time
Time frame: Baseline, Month 3, and Month 6
Change in Radiographic Severity Score From Baseline to Month 6
Time frame: Baseline and Month 6
Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Month 6
Time frame: Baseline and Month 6
Change in R5-R20 Measured by Impulse Oscillometry From Baseline to Month 6
Time frame: Baseline and Month 6
Change in Post-Bronchodilator FEV1 (% Predicted) From Baseline to Month 6
Time frame: Baseline and Month 6
Anti-NTM Treatment Initiation
Time frame: Up to Month 6
Adverse Events
Time frame: Up to Month 6
Within-Participant Change in Respiratory Severity Score During Normal Saline and Hypertonic Saline Treatment Periods in the Delayed-Initiation Arm
Time frame: Baseline to Month 6
Change in Respiratory Severity Score From Month 3 to Month 6 in the Early-Initiation Arm
Time frame: Month 3 and Month 6
Change in Total RSS at Month 6
Time frame: Baseline and Month 6
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 15 Jun 2026.
- Results publication: PubMed 31000680Huiberts A, Zweijpfenning SMH, Pennings LJ, Boeree MJ, van Ingen J, Magis-Escurra C, Hoefsloot W. Outcomes of hypertonic saline inhalation as a treatment modality in nontuberculous mycobacterial pulmonary disease. Eur Respir J. 2019 Jul 11;54(1):1802143. doi: 10.1183/13993003.02143-2018. Print 2019 Jul. No abstract available.
- Results publication: PubMed 32628747Daley CL, Iaccarino JM, Lange C, Cambau E, Wallace RJ Jr, Andrejak C, Bottger EC, Brozek J, Griffith DE, Guglielmetti L, Huitt GA, Knight SL, Leitman P, Marras TK, Olivier KN, Santin M, Stout JE, Tortoli E, van Ingen J, Wagner D, Winthrop KL. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline. Clin Infect Dis. 2020 Aug 14;71(4):e1-e36. doi: 10.1093/cid/ciaa241.
- 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.
Sheng-Wei Pan, MD, PhD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized 3% Hypertonic Saline and Nebulized Normal Saline in people with Nontuberculous Mycobacterial Lung Disease and Bronchiectasis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 8 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 15 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 Taiwan. 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 Sheng-Wei Pan, MD, PhD (+886-2-28717456, swpan2@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Respiratory Severity Score (RSS) From Baseline to Month 3 (time frame: Baseline and Month 3). 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 NCT07647575, 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 15 Jun 2026.