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Chronic Rhinosinusitis With Nasal PolypsPhase 4COMPASSNCT05598411

CST1-Guided Oral Glucocorticoids Management for CRSwNP

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 The sponsor has not verified this record for over two years, so it may be out of date.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 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?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
17 Oct 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

  • Age 18-70 years old；
  • All meet the diagnostic criteria of CRSwNP in EPOS2020;
  • Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);
  • Patients with asthma were in a stable state, with FEV1 > 50% of the predicted value or 50% of the optimal value of personal FEV1; (5) Good compliance, able to complete clinical observation.

Who cannot join

  • Medication history of oral glucocorticoids within 3 months before enrollment, antibiotics within 2 weeks;
  • Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.;
  • Any nasal and/or sinus surgery within 3 months before enrollment;
  • Patients have conditions or comorbidities that may preclude evaluation of the primary efficacy endpoint, such as: unilateral posterior nasal polyp of maxillary sinus, acute rhinitis, nasal infection or upper respiratory tract at the screening period or within 2 weeks before the screening period infection, acute asthma attack within 4 weeks, current drug-induced rhinitis, allergic fungal sinusitis (AFRS), benign or malignant tumor of nasal cavity；
  • Important clinical comorbidities that may interfere with clinical effectiveness, including but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, eosinophilic granuloma with polyvasculitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, etc.;
  • Accompanying serious diseases or recurrent chronic diseases with poor systemic control, such as (but not limited to), active infection, cardiovascular disease, tuberculosis or other pathogen infection, diabetes, autoimmune disease, HIV, hepatitis B, Hepatitis C or parasitic diseases, malignant tumors, etc.;
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  • Subjects with severe liver and kidney function injury; such as, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times the upper limit of normal, serum creatinine > the upper limit of normal value;
  • Known or suspected immunosuppression, including a history of invasive opportunistic infections (such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cysts, aspergillosis), even if the infection has subsided;
  • Women who were pregnant or planned to become pregnant during the study, or who were breastfeeding;
  • Subjects who were fertile but were reluctant to use medically approved and effective contraception;
  • Those with a history of alcohol or drug abuse;
  • Those who believed the patient had other medical or non-medical conditions that were not suitable for the study.

Trial locations and contacts

1 site in 1 country.

Lou Zhang contact

+86-13910830399

dr.luozhang@139.com

China1 site

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: Efficacy of CST1-Guided Oral Glucocorticoid Therapy 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 in nasal secretions. The goal of this randomized, double-blind, placebo-controlled clinical trial is to clarify the efficacy of a short course of CST1-guided oral glucocorticoids therapy for chronic rhinosinusitis with nasal polyps. Subjects were randomized to receive either oral glucocorticoids or oral placebo for 2 weeks. Endoscopic polyp score, Total Nasal Symptom Score(TNSS), SNOT-22 score, Cystatin 1 and other biomarkers were evaluated before and after the treatment. Researchers will compare oral glucocorticoids group and oral placebo group to test CST1 predictive model of glucocorticoid therapy for Chronic Rhinosinusitis with Polyps.

Being tested
Oral Glucocorticoids, Oral placebo

What participants receive

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

  • Oral GlucocorticoidsDrug

    Also called methylprednisolone

    methylprednisolone 24mg qd, 2-week duration

  • Oral placeboDrug

    oral placebo 24mg qd, 2-week duration

Study groups in NCT05598411
Study groupRoleWhat they receive
Oral Glucocorticoids groupExperimentalIntervention Period：oral glucocorticoids（methylprednisolone 24mg qd, 2-week duration）+nasal spray （Budesonide Nasal Spray 64ug per Nostril, bid, 2-week duration） follow-up period：nasal spray（Budesonide Nasal Spray 64ug per Nostril, bid, 24-week duration）
Receives: Drug: Oral Glucocorticoids
Placebo groupPlacebo comparatorIntervention Period：oral placebo+nasal spray（oral placebo 24mg qd, 2-week duration）+nasal spray （Budesonide Nasal Spray 64ug per Nostril, bid, 2-week duration） follow-up period：nasal spray（Budesonide Nasal Spray 64ug per Nostril, bid, 24-week duration）
Receives: Drug: Oral placebo

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 2, week 6, week 10, week 14, week 18, week 22, week 26

Secondary outcomes (8)

  1. The change in Total Nasal Symptom Score（TNSS）

    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 2, week 6, week 10, week 14, week 18, week 22, week 26

  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 2, week 6, week 10, week 14, week 18, week 22, week 26

  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 2, week 6, week 10, week 14, week 18, week 22, week 26

  4. The change of CST1

    The change of Cystatin 1

    Measured: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

  5. The change of biomarker

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

    Measured: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

  6. The change in AE / SAE recording

    Any adverse event

    Measured: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

  7. The needs of upgrading treatment

    The needs of upgrading treatment includes surgery, oral glucocorticoids or monoclonal antibodies treatment.

    Measured: Baseline, week 2, week 6, week 10, week 14, week 18, week 22, week 26

  8. The change of inflammatory cell

    The change of inflammatory cell in nasal polyps

    Measured: Baseline, week 2, week 26

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 start17 Oct 2022 (estimated)
  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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05598411
Sponsor's protocol ID
TR-COMPASS
Acronym
COMPASS
Status last verified
Oct 2022
First submitted
25 Oct 2022
Last updated
28 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 4 inclusion and 12 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 28 Oct 2022. 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. Some participants in this study may receive a placebo. 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 2, week 6, week 10, week 14, week 18, week 22, week 26). 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 NCT05598411.

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 28 Oct 2022.

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