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NCT07453771

Safety and Efficacy of Small Extracellular Vesicles Nebulizer in Patients With Allergic Rhinitis Complicated With Asthma

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

Summary

This trial aims to evaluate the safety, tolerability and efficacy of hUC-MSC-sEV-002 nebulizer in patients with allergic rhinitis and asthma. It consists of two parts: ① Single-center dose exploration (The Affiliated Hospital of Qingdao University): A 3+3 escalation design will test three doses (1×10⁸, 1×10⁹, 1×10¹⁰ particles/mL) to determine the maximum tolerated dose (MTD).Three subjects will be enrolled in each dose group. If no Dose-Limiting Toxicity (DLT) is observed among the 3 subjects, the study may proceed to the next dose exploration. If 1 out of the 3 subjects experiences DLT, an additional 3 subjects will be enrolled in the same dose group; the study may move to the next dose exploration only if no DLT is observed in these additional 3 subjects. If more than 1 out of the 3 subjects develops DLT, the previous dose group will be defined as the MTD. A total of at least 9 and at most 18 subjects will be recruited for this clinical trial. ② Multi-center case expansion: Participants will be randomized 2:1 to hUC-MSC-sEV-002 or placebo groups for efficacy comparison.Eligibility criteria: 18-60 years old; moderate-to-severe allergic rhinitis (ARIA guidelines) with positive inhaled allergen skin test; asthma diagnosed per GINA 2022; signed informed consent.Intervention: Nebulization once daily (5 times/week, 2 weeks, 10 doses total). Follow-up visits at baseline, Week 2, 4, 12, 24, including symptom scales, lung function tests, nasal endoscopy, nasal exhaled nitric oxide test, chest X-ray, blood tests, and electrocardiogram. The trial is approved by the Medical Ethics Committee of The Affiliated Hospital of Qingdao University (No. QYFYEC2025-192). Participants may withdraw anytime without affecting medical care. Study period: Aug 2025-Aug 2027. Sample size: 9-18 for Part 1; Part 2 size based on Part 1 results.

Official title: Safety and Preliminary Efficacy of Small Extracellular Vesicles (Code: hUC-MSC-sEV-002) Nebulizer in Patients With Allergic Rhinitis Complicated With Asthma: A Multicenter, Prospective, Randomized, Double-Blind Phase I/II Clinical Study

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-05

Completion Date

2027-08-31

Last Updated

2026-03-06

Healthy Volunteers

Conditions

Allergic Rhinitis Asthma

Interventions

OTHER

hUC-MSC-sEV-002 Nebulizer

Nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.

OTHER

hUC-MSC-sEV-002 Mimetic (Normal Saline)

Nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.

Inclusion Criteria: 1. Aged 18-60 years, regardless of gender; 2. Patients with moderate to severe allergic rhinitis (with sleep/work/study/daily activity impairment or distressing symptoms) meeting the diagnostic criteria of the international Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines, positive for at least one inhalant allergen skin prick test, and concurrent asthma complying with the Global Initiative for Asthma (GINA) 2022 guidelines; 3. Suboptimal response to antiallergic medication treatment for one year prior to enrollment; 4. Patients who decline allergen-specific immunotherapy, or have no available specific therapy for the relevant allergen, or failed allergen-specific immunotherapy; 5. Females of childbearing potential must agree to avoid pregnancy during study participation and for 30 days after the final visit; 6. Subjects or their legal representatives must be able to sign the informed consent form and comply with the study requirements for medication administration and follow-up. Exclusion Criteria: 1. Complicated with other nasal and sinus diseases that may affect the reasonable assessment of efficacy and/or safety; 2. Suffering from uncontrolled asthma or poorly controlled asthma symptoms; 3. Suffering from malignant tumors, severe immune diseases, long-term use of immunosuppressants, or immunodeficiency; 4. Having unstable conditions due to respiratory tract infection and/or acute asthma exacerbation within 4 weeks prior to the initial screening visit; 5. Currently receiving treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors; 6. Suffering from mental illnesses; 7. Suffering from severe systemic diseases, such as cases of peptic ulcers, diabetes mellitus, and heart failure; 8. Specific infections such as syphilis, leprosy, and tuberculosis; 9. Females who are currently pregnant, planning to become pregnant soon, or breastfeeding; 10. Patients who are currently participating in other clinical trials or have participated in other clinical trials within 30 days prior to the initial screening visit; 11. Patients who are currently receiving allergen desensitization therapy or biologic therapy; 12. Positive for hepatitis B surface antigen, hepatitis C virus antibody, syphilis serological antibody, or human immunodeficiency virus (HIV) antibody; 13. In addition to the above conditions, patients will be excluded if the investigators consider them unsuitable for participation in this clinical study for other reasons.

Locations (5)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, China

Chongqing General Hospital

Chongqing, China