Research Purpose and Background
Asthma is not just a moderate difference in clinical symptoms, but also a wide variety of asthma cilinical phenotypes in long-term clinical progression, responsiveness to treatment, and characteristic clinical patterns. - Recently, research has been conducted on various phenotypes of asthma, and there are increasing attempts to classify them into clusters with different clinical characteristics within each group. - By classifying the representative endotype of asthma based on the acid composition asthma, customized treatment according to individual phenotypes and intrinsic types of patients can be performed and the responsiveness to important steroid therapy can be predicted.
2) T2 high (eosinophilic asthma) produces type 2 cytokines (IL-4, 5,13) in Th2 cells and ILC2 (group 2 innate lymphoid cells), and these cytokines mobilize eosinophils and induce maturation, tissue survival, etc. This induced Hosan-gu damages the bronchial epithelium, causes bronchial contraction with leukotriene secretion, and is also involved in bronchial inflammation and mucus overproduction. It can be distinguished through biomarkers such as peripheral blood and induced guest-damaged homophosphorus, serum IgE, serum periostin, and exhalation nitric oxide, and is known to be responsive to steroid treatment.
3) T2 low (non-eosinophilic asthma, non-allergic asthma) includes Th1 producing interferon-gamma and Th17 immune responses expressing IL-17,22 which are mainly associated with increased steroid resistance. Compared to the T2 high phenotype, there is still much unknown and progress in treatment development is not significant.
4) Patients with mild asthma are advised to use inhalation steroids from the early stages to suppress airway inflammation of asthma, but the effect of inhalation steroids in patients with T2 low phenotype compared to patients with T2 high phenotype is not known. A recent study found that there was no significant difference in treatment effects in groups administered momentaone or tiotropium (LAMA) compared to the group administered placebo in patients with T2 low mild persistent asthma with low levels of gantam hosan-gu. Considering the side effects of prolonged use of inhalation steroids, the treatment dilemma of continuous use of inhalation steroids in patients with mild asthma of T2 low phenotypic.
5) In this study, we want to verify that LAMA is not inferior compared to ICS in T2 low mild asthma.
£ Research method
- Multi-organically prospective RCT to generate evidence for bronchoproliferative therapy (LAMA), which does not contain inhalation steroids (ICS) in T2 low mild asthma, to be inferior to the ICS inclusion group.
- Patients with mild asthma who remain stable with low dose inhalation steroids for more than 3 months with low dose ICS, LTRA after a month of drug interruption, blood eosinophil, allergen skin test, FeNO, and sputum analysis, are subject to T2 low criteria. Upon commencement of the study, the drug used with low dose ICS and LTRA is stopped and drugged according to the study plan.
- Sampling for biomarker analysis is carried out simultaneously.
- Half of the 300 patients evaluated with non-affective/non-allergic (T2 low) asthma are treated with ICS for 6 months first, followed by a 2 month wash-out period for an interim evaluation and a reevaluation of T2 low. After receiving treatment with LAMA for six months, the treatment results will be evaluated. The rest of the asthmatic patients receive six months of LAMA treatment first and two months of wash-out period for interim evaluation and T2 low evaluation. After receiving treatment with ICS for six months, treatment results will be evaluated. 300 patients will be monitored for 12 months.

Cohort/Group Label

ICS (Inhaled Corticosteroid) treatment group

Cohort/Group Description

It uses only ICS(Inhaled Corticosteroid) for six months to treat T2 low mild asthma.

Cohort/Group Label

LAMA(Long Acting Muscarine Agonist) treatment group

Cohort/Group Description

It uses only LAMA(Long Acting Muscarine Agonist) for six months to treat T2 low mild asthma.

: DNA Collect & Archive: Sample with DNA

sputum, urine, blood, nasal cells, Exhaled Breath Condensation

Patients aged 18 to 80 using tertiary medical institutions with T2 low mild asthma

Simple random sampling method

Gender

Age

Description

1) Adult asthma patients between the ages of 18 and 80 years old
2) Definition of patients with mild asthma (GINA steps 1 to 2)
Absolute Criteria: Blood eosinophil less than 300 & allergen check
(skin tests 14 or more or MAST tests) All negative
FENO (less than 25) or sputum eosinophil (less than 3%) in patients who meet the above absolute criteria.
Register if one is satisfied
- The above criteria are applied the same when reassessing the washout visibility after 6 months.
3) For more than three months, use low dose ICS only, LRTA only, or prn Ventolin without worsening asthma.
The T2 low criteria above are tested after a month of drug interruption in a stable patient.
a satisfied patient
4) New asthma-diagnosed mild case
5) FEV1 (%) > 80

1) Minors under the age of 18 and older than 80 years of age;
2) Smoking power of 10PY or higher or current smokers
3) In case of acute deterioration of steroid injection above 30 mg prednisolone was required within 6 months prior to registration of the study;
4) In addition to severe asthma, severe respiratory diseases are accompanied by clinically significant respiratory diseases
5) In case it is difficult to evaluate asthma alone due to severe respiratory diseases (Lung canner, Tb destroyed Lung, Interstitial Lung disease, etc.)
6) Hypereosinophilic syndrome, ABPA, EGPA, COPD
7) Pregnant women
8) Patients who are unable to use LAMA drugs due to side effects
£ Benign prostatic hypertrophy (BPH) in severe cases
£ Glaucoma
£ New disease

The primary outcome variable in Detailed Task 1 is the response difference determined by the hierarchical critteria. In phase I clinical trials, each patient experiences both ICS and LAMA treatments according to cross-over design, and then measures which treatment they responded to better. Conduct a hypothesis test for non-equivalence. Since the null hypothesis is tested and the non-equivalence test is a one-sided test, the significance level of 0.025 is used to ensure the same rigor as a typical two-sided test. The secondary result variables are analyzed using the generalized linear mixed model using the link function according to the variable type. Use drugs and baseline charateristics as fixed effects and random effects for each patient's organ.

It will be evaluated after 2024.12.31 when the study is completed.

Continuous variables (such as asthma control score, symptom control survey, lung function, etc.) are analyzed using mixed effects linear regression method to satisfy normality if necessary, and count variables such as asthma deterioration frequency and frequency of use are analyzed.

It will be evaluated after 2024.12.31 when the study is completed.