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

ConditionBronchial Asthma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Budesonide Formoterol

    Drug

    Investigator Selection

  • Placebo

    Drug

    Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months

  • Immune Modulators (Staphylococcus and Neisseria Tablets)

    Drug

    Staphylococcus and Neisseria Tablets: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Budesonide Formoterol combined with placeboPlacebo comparator 2 interventions
Group B: Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The overall asthma control rate at 12 weeks of treatment

The overall control rate = (number of well-controlled cases + number of partially controlled cases) / total number of cases × 100%

Time frame
week 12

Secondary outcomes

1

The overall asthma control rate at 24 weeks of treatment

The overall control rate = (number of well-controlled cases + number of partially controlled cases) / total number of cases × 100%

Time frame
week 24
2

Number of acute asthma exacerbations

Time frame
Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
3

Changes in Asthma Control Test (ACT) scores

The minimum and maximum scores of the Asthma Control Test are 5 and 25 points respectively. The higher the ACT score, the better the asthma control.

Time frame
Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
4

Changes in lung function indicators compared to baseline

Changes in PEF

Time frame
Month 3, Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: