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

Condition(s) studied

Investigational drug(s) / intervention(s)

hUC-MSC-sEV-002 Nebulizer: Nebulization therapy, once daily, 5 nebulizations per week, for 2 consecutive weeks, totaling 10 times.

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

Study 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.

Eligibility

Primary outcome measure(s)

• Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) — At Week 24
  It consists of 7 domains and 28 items, with each item scored on a scale of 0 to 6. Each domain is scored independently, and the sum of all domain scores yields the total RQLQ score, which ranges from 0 to 168. A higher total score indicates a greater negative impact of the disease on the patient's quality of life.
• Forced Expiratory Volume in One Second (FEV1) — At Week 24
  Pulmonary function tests are conducted to obtain the value of FEV1, with the unit of FEV1 being liters (L). A percentage of the measured FEV1 value relative to the predicted value of 80% or higher is defined as normal.
• Drug-related adverse reaction rate — In the short term after treatment (0-24 hours)；At Week 2
  The incidence of treatment-related adverse events within the short-term post-treatment period (0 to 24 hours);The incidence of treatment-related adverse events at 2 weeks post-treatment.
• Blood Pressure — At Week 2
  Systolic blood pressure (SBP) and diastolic blood pressure (DBP) shall be measured separately. The reference range for SBP is 90 mmHg to 139 mmHg, and the reference range for DBP is 60 mmHg to 89 mmHg.
• Changes in routine blood test — At Week 2
  We performed routine blood tests via venous blood collection and recorded any changes compared with baseline.
• Changes in routine urine test — At Week 2
  Urine specimens were collected for routine urinalysis, and any abnormal changes from baseline were documented.
• Whether abnormal changes occurred in the ECG — At Week 2
  Electrocardiography (ECG) will be performed to evaluate whether there are any abnormalities in the patient's heart rate or cardiac rhythm.
• Total Nasal Symptom Score (TNSS) — At Week 24
  It consists of 4 items, with each item scored on a scale of 0 to 3. The total score ranges from 0 to 12, with a higher total score indicating more severe disease symptoms.
• Visual Analog Scale (VAS) — At Week 24
  It is used to assess the severity of symptoms, with the total score ranging from 0 to 10. A higher total score indicates more severe disease symptoms.
• Asthma Control Test (ACT) — At Week 24
  It is used to assess asthma control, with the total score ranging from 0 to 25. A higher total score indicates better asthma control.
• Peak Expiratory Flow (PEF) — At Week 24
  Pulmonary function tests are conducted to obtain the value of PEF, with the unit of PEF being liters per second (L/s). A percentage of the measured PEF value relative to the predicted value of 80% or higher is defined as normal.
• Heart Rate — At Week 2
  The unit of heart rate is beats per minute, with a normal range of 60 to 100 bpm.
• Body Temperature — At Week 2
  The unit is degrees Celsius (°C), with a normal range of 36.0 °C to 37.0 °C.
• C-reactive protein (CRP) — At Week 2
  Venous blood sampling is performed for C-reactive protein (CRP) testing.The unit is mg/L, with a normal reference range of 0 to 5 mg/L.
• Alanine aminotransferase (ALT) — At Week 2
  Venous blood sampling is performed for liver function tests. Alanine aminotransferase (ALT) is measured in U/L, with a normal reference range of 7-40 U/L for females and 9-50 U/L for males.
• Creatinine — At Week 2
  Venous blood sampling is performed for renal function tests.The unit for creatinine is μmol/L, with a normal reference range of 41-81 μmol/L for females and 57-111 μmol/L for males.
• IgG, IgA, IgM, C3 ,C4 — At Week 2
  Venous blood sampling is performed for five immunological indicators, which mainly includes IgG, IgA, IgM, C3 and C4.The units for all the above indicators are g/L. Normal reference ranges:IgG: 8.6-17.4 g/L；IgA: 1.0-4.2 g/L；IgM: 0.3-2.2 g/L；C3: 0.7-1.4 g/L；C4: 0.1-0.4 g/L.
• Aspartate aminotransferase (AST) — At Week 2
  Venous blood sampling is performed for liver function tests. Aspartate aminotransferase (AST) is measured in U/L, with a normal reference range of 13-35 U/L for females and 15-40 U/L for males.

Trial sites (5)

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