SinusitisPhase 3NCT05390255

Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis

A Phase 3 study testing Mometasone furoate nasal spray hormone, Mometasone furoate nasal spray hormone + oral hormone and Mometasone furoate nasal spray hormone + omalizumab in people with Sinusitis, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

Chronic rhinosinusitis that recurs after adequate surgery and conventional medical treatment is called refractory chronic rhinosinusitis (RCRS). Omalizumab and oral glucocorticoid therapy can play an important role in the treatment of RCRS, but there is still a lack of comparative studies on the efficacy and safety of… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Sinusitis
What is being tested?: Mometasone furoate nasal spray hormone, Mometasone furoate nasal spray hormone + oral hormone and Mometasone furoate nasal spray hormone + omalizumab
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteChina
Study dates: 25 May 2022to 31 Dec 2024
Phase: Phase 3
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

(1) Age 18-70 years old;
(2) All meet the diagnostic criteria of CRS in EPOS2020;
(3) Patients with asthma were in a stable state, with FEV1 > 80% of the predicted value or 80% of the optimal value of personal FEV1;
(4) Good compliance, able to complete clinical observation. Meet the diagnostic criteria for RCRS that the number of eosinophils per high power field in the nasal mucosa is >55 or the percentage of eosinophils in the tissue is ≥27%;
(5) Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) of 4-6 (minimum score of 2 per nasal cavity);
(6) Male or eligible female subjects (female subjects not pregnant or breastfeeding);
(7) Ability to sign an informed consent form, including compliance with the requirements and restrictions outlined in the Informed Consent Form (ICF) and this protocol.

Who cannot join

(1) Medication history of oral glucocorticoids within 3 months before enrollment, glucocorticoid atomization treatment and nasal hormone spray treatment within 2 weeks;
(2) Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.;
(3) Any nasal and/or sinus surgery within 3 months before enrollment;
(4) 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, severe nasal septal deviation (Obstruction of one nostril, preventing full evaluation of nasal polyps in both nostrils), undergoing sinus or sinus surgery to alter the structure of the nasal wall resulting in an inability to evaluate the nasal polyp score, persistent drug-induced rhinitis (rebound or chemical-induced rhinitis);
(5) 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.;
(6) 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.;

Show all 15Show fewer

(7) 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; liver cirrhosis or currently unstable liver or biliary disease as assessed by the investigator;
(8) 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;
(9) Suffering from known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, hepatic, hematological or other systemic abnormalities that have not been controlled by standard treatment;
(10) Patient has been exposed to ionizing radiation above background 10mSv in the past 3 years due to occupational exposure or previous study participation (excluding clinically reasonable therapeutic or diagnostic exposure);
(11) Women who were pregnant or planned to become pregnant during the study, or who were breastfeeding;
(12) Subjects who were fertile but were reluctant to use medically approved and effective contraception;
(13) Those with a history of alcohol or drug abuse;
(14) Those who had been treated with monoclonal antibodies in the 6 months prior to enrollment;
(15) 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.

China1 site, 1 recruiting

Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Luo Zhang, M.D., (86)13910830399, dr.luozhang@gmail.com
Luo Zhang
Recruiting

Other trials in China

About this study

In this study, patients aged 18-70 who were diagnosed with CRS were consecutively enrolled, and the patients were divided into RCRS and non-RCRS groups according to pathological results. The patients in the RCRS group were randomly divided (1:1:1) into the nasal spray hormone therapy group, the nasal spray hormone therapy + oral hormone therapy group, and the nasal spray hormone therapy + omalizumab therapy group by a multi-center, randomized, controlled study. The patients were treated for 6 months and followed up for 6 months after treatment. Clinical data such as symptom score and endoscopic score before and after treatment were collected, adverse events were recorded, and the differences in efficacy and safety among the groups were compared. Non-invasive samples such as nasal secretions and exfoliated cells were collected, and the expression and variation of different immune intrinsic markers were explored combined with follow-up results. The development of this project contributes to the establishment of a precise diagnosis and treatment system for refractory chronic sinusitis.

Conditions: Sinusitis
Being tested: Mometasone furoate nasal spray hormone, Mometasone furoate nasal spray hormone + oral hormone, Mometasone furoate nasal spray hormone + omalizumab
Keywords: Refractory chronic sinusitis, Randomized Controlled Trial, Hormone therapy, Omalizumab, Biomarkers
Medical subject headings: Sinusitis

What participants receive

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

Mometasone furoate nasal spray hormoneDrug
This group of patients received mometasone furoate nasal spray hormone treatment throughout the study.
Mometasone furoate nasal spray hormone + oral hormoneDrug
The patients in this group were given oral hormone therapy for 14 days in the first month and the fourth month under the background of mometasone furoate nasal spray hormone treatment throughout the course.
Mometasone furoate nasal spray hormone + omalizumabDrug
The patients in this group were injected with omalizumab once a month under the background of mometasone furoate nasal spray hormone treatment, for a total of 6 times.

Study groups in NCT05390255
Study group	Role	What they receive
Nasal spray hormone therapy	Experimental	This group of patients received nasal steroid therapy throughout the study. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated. Receives: Drug: Mometasone furoate nasal spray hormone
Nasal spray hormone therapy + oral hormone therapy	Experimental	The patients in this group were given oral hormone therapy for 14 days in the first month and the fourth month under the background of nasal spray hormone treatment throughout the course. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated. Receives: Drug: Mometasone furoate nasal spray hormone + oral hormone
Nasal spray hormone therapy + omalizumab therapy	Experimental	The patients in this group were injected with omalizumab once a month under the background of nasal spray hormone therapy, for a total of 6 times. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated. Receives: Drug: Mometasone furoate nasal spray hormone + omalizumab

What is being measured

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

The change in endoscopic 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 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9, month 12

Secondary outcomes (7)

The change in nasal symptoms
Nasal symptom was assessed using the Visual Analog Scale (VAS). The symptoms are graded on a 10-point scale (0 = no symptoms; 10 = most severe symptoms).
Measured: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 7, month 8, month 9, month 10, month 11,month 12
The change in sinus CT score
The Lund-Mackay imaging scoring system was used for the CT scan results of the sinuses (0, 1, and 2 were used for each frontal sinus, anterior ethmoid sinus, posterior ethmoid sinus, maxillary sinus, and sphenoid sinus, indicating no opacity, partial opacity and all turbidity of the sinus cavity respectively; 0 and 2 were used for each side of the sinus complex to indicate no blockage and presence of blockage) to calculate the total score and E/M value (bilateral ethmoid total score/bilateral maxillary sinus total score), etc.
Measured: Baseline, week 24
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 4, week 8, week 12, week 14, week 16, week 20, week 24, month 7, month 8, month 9, month 10, month 11,month 12
The change in exfoliated cells and secretions
Changes in expression levels of T1, T2, T3 factors and T2 inflammatory markers CST1 and CLC in nasal brush exfoliated cells and nasal secretions.
Measured: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9,month 12
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 4, week 8, week 12, week 14, week 16, week 20, week 24, month7, month 8, month 9, month 10, month 11, month 12
The change in AE / SA recording
Measured: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month7, month8, month 9, month 10, month 11, month 12
The change in serum cortisol
Measured: Baseline, week 24

Timeline

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

25 May 202231 Dec 2024

First posted25 May 2022
Study start25 May 2022 (estimated)
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SinusitisStudies of the same condition, open and under way.
More trials run by Beijing Tongren HospitalThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 87 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05390255
Sponsor's protocol ID: TR-system for RCRS
Status last verified: May 2022
First submitted: 6 May 2022
Last updated: 25 May 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis

All Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis
ClinicalTrials.gov ID: NCT05390255
Acronym / sponsor ID: TR-system for RCRS
Conditions: Sinusitis
Keywords: Refractory chronic sinusitis, Randomized Controlled Trial, Hormone therapy, Omalizumab, Biomarkers
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 87 participants (estimated)
Lead sponsor: Beijing Tongren HospitalUniversity, hospital or other
Collaborators: Peking Union Medical College Hospital, Beijing Hospital
Study start: 25 May 2022 (estimated)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 25 May 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Nasal spray hormone therapy	Experimental	Drug: Mometasone furoate nasal spray hormoneThis group of patients received nasal steroid therapy throughout the study. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated.
Nasal spray hormone therapy + oral hormone therapy	Experimental	Drug: Mometasone furoate nasal spray hormone + oral hormoneThe patients in this group were given oral hormone therapy for 14 days in the first month and the fourth month under the background of nasal spray hormone treatment throughout the course. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated.
Nasal spray hormone therapy + omalizumab therapy	Experimental	Drug: Mometasone furoate nasal spray hormone + omalizumabThe patients in this group were injected with omalizumab once a month under the background of nasal spray hormone therapy, for a total of 6 times. The clinical data of patients at baseline and each visit period were collected, the incidence of adverse events was recorded, and the short-term efficacy and safety of different drug treatment regimens were evaluated.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

(1) Age 18-70 years old;
(2) All meet the diagnostic criteria of CRS in EPOS2020;
(3) Patients with asthma were in a stable state, with FEV1 > 80% of the predicted value or 80% of the optimal value of personal FEV1;
(4) Good compliance, able to complete clinical observation. Meet the diagnostic criteria for RCRS that the number of eosinophils per high power field in the nasal mucosa is >55 or the percentage of eosinophils in the tissue is ≥27%;
(5) Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) of 4-6 (minimum score of 2 per nasal cavity);

Key exclusion criteria (15 listed)

(1) Medication history of oral glucocorticoids within 3 months before enrollment, glucocorticoid atomization treatment and nasal hormone spray treatment within 2 weeks;
(2) Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.;
(3) Any nasal and/or sinus surgery within 3 months before enrollment;
(4) 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, severe nasal septal deviation (Obstruction of one nostril, preventing full evaluation of nasal polyps in both nostrils), undergoing sinus or sinus surgery to alter the structure of the nasal wall resulting in an inability to evaluate the nasal polyp score, persistent drug-induced rhinitis (rebound or chemical-induced rhinitis);
(5) 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.;

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
Mometasone furoate nasal spray hormoneThis group of patients received mometasone furoate nasal spray hormone treatment throughout the study.	Drug	Nasal spray hormone therapy
Mometasone furoate nasal spray hormone + oral hormoneThe patients in this group were given oral hormone therapy for 14 days in the first month and the fourth month under the background of mometasone furoate nasal spray hormone treatment throughout the course.	Drug	Nasal spray hormone therapy + oral hormone therapy
Mometasone furoate nasal spray hormone + omalizumabThe patients in this group were injected with omalizumab once a month under the background of mometasone furoate nasal spray hormone treatment, for a total of 6 times.	Drug	Nasal spray hormone therapy + omalizumab therapy

Primary outcome

The change in endoscopic score
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9, month 12
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.)

7 secondary outcomes

The change in nasal symptoms
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 7, month 8, month 9, month 10, month 11,month 12
The change in sinus CT score
Time frame: Baseline, week 24
The change in SNOT-22 score
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 7, month 8, month 9, month 10, month 11,month 12
The change in exfoliated cells and secretions
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9,month 12
The change in asthma ACQ Score
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month7, month 8, month 9, month 10, month 11, month 12
The change in AE / SA recording
Time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month7, month8, month 9, month 10, month 11, month 12
The change in serum cortisol
Time frame: Baseline, week 24

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
Individual participant dataSharing planned: No

Related trials for Sinusitis

RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis

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. This study is not recruiting at the moment.

Beijing Tongren Hospital

Beijing, China

(86)13910830399

dr.luozhang@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 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 25 May 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in endoscopic score (time frame: Baseline, week 2, week 4, week 8, week 12, week 14, week 16, week 20, week 24, month 9, month 12). 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 NCT05390255.

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 25 May 2022.