Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-02
Brief Title:
Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis
Sponsor:
Beijing Tongren Hospital
Organization:
Beijing Tongren Hospital
Study Overview
Official Title:
The Efficacy and Safety of Humanized Antibody Targeting the Interleukin-4 Receptor Alpha Subunit IL-4Rα in Patients With Uncontrolled Seasonal Allergic Rhinitis Under Standard Treatment A Randomized Double-Blind Placebo-controlled IIT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEGREZ
Brief Summary:
Allergic rhinitis AR is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals The typical symptoms of AR are paroxysmal sneezing watery rhinorrhea itching and nasal congestion which may be accompanied by ocular symptoms including eye itching tearing redness and burning sensation which are more common in patients with hay fever allergies Bronchial asthma is associated with bronchial asthma in 40 of patients with AR suggesting a comorbid feature of allergic disease
Detailed Description:
AR is a common clinical chronic nasal disease affecting 10 to 20 of the worlds population and has become a global health problem AR not only seriously affects the quality of life of patients resulting in patient fatigue impaired learning attention and decision-making ability but also causes a heavy social burden
AR has a variety of classification methods According to the type of allergen it can be divided into seasonal SAR common allergens are seasonal allergens such as pollen and perennial PAR common allergens are indoor allergens such as dust mites or occupational allergies which is a classification method often used in clinical studies According to the course of the disease it can be divided into intermittent symptom onset 4 daysweek or 4 consecutive weeks and persistent symptom onset 4 daysweek and 4 consecutive weeks According to the severity of the disease it can be divided into minor AR mild symptoms with no significant impact on quality of life and moderate-severe AR more severe or severe symptoms with significant impact on quality of life The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population accounting for 522 indicating that the treatment and control of AR has become an urgent problem to be solved
AR has a variety of classification methods According to the type of allergen it can be divided into seasonal SAR common allergens are seasonal allergens such as pollen and perennial PAR common allergens are indoor allergens such as dust mites or occupational allergies which is a classification method often used in clinical studies According to the course of the disease it can be divided into intermittent symptom onset 4 daysweek or 4 consecutive weeks and persistent symptom onset 4 daysweek and 4 consecutive weeks According to the severity of the disease it can be divided into minor AR mild symptoms with no significant impact on quality of life and moderate-severe AR more severe or severe symptoms with significant impact on quality of life The results of the cooperative survey showed that persistent moderate-to-severe disease was the most common in the overall population accounting for 522 indicating that the treatment and control of AR has become an urgent problem to be solved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None