NCT06895460

A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma with Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)

Detailed description

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial. A total of 198 participants with bronchial asthma are planned to be enrolled and randomized in a 1:1 ratio to the experimental group and the control group. The experimental group will receive Budesonide Formoterol Powder for Inhalation plus immune modulators (Staphylococcus and Neisseria Tablets), while the control group will receive Budesonide Formoterol Powder for Inhalation plus placebo. The treatment period is 3 months for both groups, followed by a 3-month follow-up after treatment.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	Budesonide Formoterol	Investigator Selection
DRUG	Placebo	Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months
DRUG	Immune Modulators (Staphylococcus and Neisseria Tablets)	Staphylococcus and Neisseria Tablets: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months

Timeline

• Start date: 2025-06-20
• Primary completion: 2027-06-30
• Completion: 2027-09-30
• First posted: 2025-03-26
• Last updated: 2025-06-05

Locations

1 site across 1 country: China