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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05470647
Other study ID # CM310_IIS_SAR05
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 17, 2022
Est. completion date December 28, 2022

Study information

Verified date October 2023
Source Beijing Tongren Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's 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 days/week, or < 4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, 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 52.2%, indicating that the treatment and control of AR has become an urgent problem to be solved.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date December 28, 2022
Est. primary completion date September 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Voluntarily sign the informed consent form. Exclusion Criteria: - Have any condition that are not suitable for participating in this study.

Study Design


Intervention

Biological:
Interleukin-4 receptor responders 1
Interleukin-4 receptor was injected subcutaneously.
Interleukin-4 receptor responders 2
Interleukin-4 receptor was injected subcutaneously.
Placebo
Placebo was injected subcutaneously.

Locations

Country Name City State
China Beijing Tongren Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. Average change from baseline in daily retrospective total nasal symptom score (rTNSS) during treatment period. The Total Nasal Symptom Score (TNSS) is the sum of the four symptom scores of runny nose, nasal congestion, nasal itching, and sneezing, with each symptom scoring from 0 to 3. up to week 2
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