Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06895460
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 14 years, male or female;
2. Confirmed diagnosis of asthma at least 6 months prior to screening;
3. Patients with uncontrolled asthma (according to the 2024 GINA guidelines-asthma control level classification criteria, patients with partially controlled and uncontrolled asthma);
4. Within the past 6 months, at least one of the following positive test results for lung function:
* Positive bronchodilator test with an increase in FEV1 of ≥12%, and an absolute increase in FEV1 of ≥200 ml;
* Positive bronchial provocation test or exercise challenge test;
* Peak expiratory flow (PEF) variability over 2 weeks with a daily variation rate of ≥20% or a weekly average variation rate of ≥10%;
* Significant improvement in lung function after 4 weeks of asthma treatment, with an increase in FEV1 of ≥12%, an absolute increase in FEV1 of ≥200 ml, or an improvement in PEF of ≥20%;
5. Before the first administration of the study drug, the patient has good function of major organs and no contraindications to ICS + LABA treatment;
6. The participant (or their legal representative) must sign and date the informed consent form, indicating their understanding of the study's purpose and the procedures involved, and their willingness to participate in the study.
Exclusion Criteria:
1. Patients with a history of severe asthma (according to the definition in the Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition));
2. Patients in the acute exacerbation phase who may require intravenous/oral corticosteroids;
3. Patients with rheumatology and immunology conditions;
4. Atypical asthma or comorbidities such as pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, pulmonary embolism, severe respiratory failure, or other respiratory system diseases;
5. Individuals with significant diseases other than bronchial asthma. Significant diseases are defined as conditions that, in the investigator's judgment, may place the participant at risk or affect the study results, such as severe cardiovascular, cerebrovascular, hepatic, renal, hematologic diseases, malignancies, psychiatric disorders, immune system diseases, or pulmonary organic functional impairments;
6. Individuals allergic to the study drug or corticosteroids;
7. Participation in another clinical trial within 30 days prior to screening or currently ongoing;
8. Use of immune modulators (including thymosin, thymopeptides, interferon, transfer factor, Bacillus Calmette-Guérin polysaccharides, any type of bacterial extracts, such as Biostim, bacterial lysate capsules) within 30 days prior to the use of the study drug or during the study period;
9. Women who are currently pregnant or breastfeeding, or women of childbearing potential who cannot use contraception during the study period;
10. The participant is deemed unsuitable for study observation by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT06895460
Study Brief:
Protocol Section:
NCT06895460