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.
