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

Sponsor
The Affiliated Hospital of Qingdao University
Study ID
NCT07453771
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • hUC-MSC-sEV-002 Nebulizer — OTHER
    Nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.
  • hUC-MSC-sEV-002 Mimetic (Normal Saline) — OTHER
    Nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.

Study Details

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.

Key Dates

First listed
Mar 6, 2026
Start date
Mar 5, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: hUC-MSC-sEV-002 nebulizer
    hUC-MSC-sEV-002 nebulizer, nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.
  • Placebo Comparator: hUC-MSC-sEV-002 Mimetic (Normal Saline)
    A control arm is established in Phase II of the clinical trial.hUC-MSC-sEV-002 Mimetic (Normal Saline), nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.

Primary Outcome Measure

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: At Week 24 ]

Central Contacts

Find similar trials

Nationwide
Asthma trialsPulmonology trialsLung disease trials

Related Studies