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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age14+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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)

Eligibility criteria

Qualifiers

Age ≥ 14 years, male or female;

Confirmed diagnosis of asthma at least 6 months prior to screening;

Patients with uncontrolled asthma (according to the 2024 GINA guidelines-asthma control level classification criteria, patients with partially controlled and uncontrolled asthma);

Positive bronchodilator test with an increase in FEV1 of ≥12%, and an absolute increase in FEV1 of ≥200 ml;

Disqualifiers

Patients with a history of severe asthma (according to the definition in the Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition));

Patients in the acute exacerbation phase who may require intravenous/oral corticosteroids;

Patients with rheumatology and immunology conditions;

Atypical asthma or comorbidities such as pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, pulmonary embolism, severe respiratory failure, or other respiratory system diseases;

Trial design

Treatments tested in this trial

  • Budesonide Formoterol
  • Placebo
  • Immune Modulators (Staphylococcus and Neisseria Tablets)

Treatment groups

198 Participants
are divided into 2 treatment groups