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Chronic Rhinosinusitis With Nasal PolypsPhase 4NCT05598424

CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps

A Phase 4 study testing Oral Glucocorticoids in people with Chronic Rhinosinusitis With Nasal Polyps and Glucocorticoids, run by Beijing Tongren Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. Glucocorticoids sensitivity is significantly correlated with CST1 level in nasal secretions. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Oral Glucocorticoids
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
22 Nov 2022to 1 Nov 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All meet the diagnostic criteria of CRSwNP in EPOS2020 (Age 18-70 years old);
  • Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);

Who cannot join

  • Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.
  • Medication history of oral glucocorticoids or immunomodulator within 1 months before enrollment, antibiotics within 2 weeks;
  • fungal sinusitis, allergic fungal sinusitis (AFRS), cystic fibrosis, primary ciliary dyskinesia

Trial locations and contacts

1 site in 1 country.

Lou Zhang contact

+86-13910830399

dr.luozhang@139.com

China1 site, 1 recruiting

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

    Luo Zhang, +86-13910830399, dr.luozhang@139.com

    Recruiting

Other trials in China

About this study

Official title: Establishment of CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps

Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. Glucocorticoids sensitivity is significantly correlated with CST1 level in nasal secretions. The goal of this single-arm clinical trial based on a multicenter platform is to test CST1 in patients with chronic rhinosinusitis and nasal polyps before and after oral glucocorticoid therapy. Endoscopic polyp score, Total Nasal Symptom Score(TNSS), SNOT-22 score and other biomarkers are also evaluated before and after the treatment. Researchers will develop a CST1 predictive model of oral glucocorticoid therapy for Chronic Rhinosinusitis with Polyps.

Being tested
Oral Glucocorticoids

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral GlucocorticoidsDrug

    Also called methylprednisolone

    Oral Glucocorticoids（methylprednisolone） 24mg qd, 2-week duration

Study groups in NCT05598424
Study groupRoleWhat they receive
Oral Glucocorticoids groupExperimentalIntervention Period I: nasal spray, Budesonide Nasal Spray, 64ug per Nostril, bid, for 4-week duration. Intervention Period II: oral glucocorticoids methylprednisolone 24mg qd, and nasal spray, Budesonide Nasal Spray 64ug per Nostril, bid, for 2-week duration.
Receives: Drug: Oral Glucocorticoids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in endoscopic polyp score

    Bilateral polyp volume size described using the Nasal Polyp Size Score (NPSS) score. (0 - 4 points per side: 0 = no polyp; 1 = small polyp in the middle meatus, not reaching the inferior border of the middle turbinate; 2 = small polyp in the middle meatus, reaching the inferior border of the middle turbinate; 3 = large polyp protruding from the middle meatus, not reaching the inferior border of the inferior turbinate; 4 = large polyp that almost causes most or complete obstruction of the nasal cavity.)

    Measured: Baseline, week 4, week 6

Secondary outcomes (8)

  1. The change in Total Nasal Symptom Score

    Total Nasal Symptom Score was are graded on a 3-point scale. (0= no symptoms; 1= mild symptoms; 2= moderate symptoms; 3= severe symptoms).

    Measured: Baseline, week 4, week 6

  2. The change in SNOT-22 score

    The 22-item Sino-nasal outcome test (SNOT-22) was used to evaluate the changes in symptoms of patients.

    According to the severity of symptoms caused by RCRS, each item was divided into 6 levels: no distress (0 points), mild distress (1 point), mild distress (2 points) ), moderate distress (3 points), severe distress (4 points), very severe distress (5 points). The higher the score, the more severe the symptoms, and the final total score of the item is counted.

    Measured: Baseline, week 4, week 6

  3. The change in asthma ACQ Score

    For patients with asthma, we assessed the change of asthma symptoms through the Asthma Control Questionnaire(ACQ). Each question was scored on a scale of 0 to 6 according to the severity. The result score of each item was averaged. A score of <0.75 indicated that the asthma had been completely controlled; a score of 0.75-1.5 indicates well-controlled asthma; a score of >1.5 indicates that asthma is not controlled.

    Measured: Baseline, week 4, week 6

  4. The change of CST1

    The change of Cystatin 1

    Measured: Baseline, week 4, week 6

  5. The change of biomarker

    Changes in expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.

    Measured: Baseline, week 4, week 6

  6. The change in AE / SAE recording

    Any adverse event

    Measured: Baseline, week 4, week 6

  7. The change of inflammatory cell

    The change of inflammatory cell in nasal polyps

    Measured: week 4, week 6

  8. The change of serum cortisol

    The change of serum cortisol level

    Measured: Baseline, week 4, week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2022
  2. Study start22 Nov 2022
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05598424
Sponsor's protocol ID
TR-CST1
Status last verified
Mar 2023
First submitted
25 Oct 2022
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yan B, Meng C, Lu M, Xian M, Wang X, Deng Y, Wang J, Chen Z, Zhang L, Wang C. Integrated-omics endotyping of patients with chronic rhinosinusitis with nasal polyps and their response to glucocorticoid therapy. J Allergy Clin Immunol. 2026 Oct 9:S0091-6749(26)00714-1. doi: 10.1016/j.jaci.2026.07.029. Online ahead of print.

    PubMed 42854989

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral Glucocorticoids in people with Chronic Rhinosinusitis With Nasal Polyps and Glucocorticoids, run by Beijing Tongren Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lou Zhang (+86-13910830399, dr.luozhang@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in endoscopic polyp score (time frame: Baseline, week 4, week 6). 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 NCT05598424, which also lists 1 linked publication.

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 Mar 2023.

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