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The potential therapeutic role of ICS/LABA with extrafine particles in asthma

The potential therapeutic role of ICS/LABA with extrafine particles as maintenance and reliever therapy for relieving small airway obstruction in asthma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006933
Enrollment
40
Registered
2022-01-18
Start date
2021-08-02
Completion date
Unknown
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1) Individuals meeting the inclusion criteria are screened and all participants provided written informed consent before participation. Patients at the first visit were identified with clini

Sponsors

Gachon University Gil Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients over 19 years of age 2. Typical asthma symptoms (night/dawn, cold, exercise, changes in weather, smoke/allergens/stimulating odor exposure, and difficulty breathing, coughing, chest tightness) 3.Positive bronchodilator response (FEV1 is 12%, 200ml increase) or metacholine provocation test (PC20 less than 16mg/mL) 4. Patients who entered GINA Step 3 with a low dose ICS/LABA treatment 5. Patients who can use dry powder inhaler

Exclusion criteria

Exclusion criteria: 1. Malignancy and other serious diseases that may affect this study 2. Previous use of Foster Nexthaler and Duoresp Spiromax inhaler. 3. Pregnancy or lactation 4. Not suitable for use of dry powder inhaler 5. refusal to participate the study

Design outcomes

Primary

MeasureTime frame
Forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%)

Secondary

MeasureTime frame
Pre-bronchodilator FEV1;Pre-bronchodilator FEV1/FVC;Asthma Control Test (ACT) ;Asthma Control Questionnaire (ACQ);Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA);Safety ;Inhaler preference

Countries

Korea, Republic of

Contacts

Public ContactSung-Yoon Kang

Gachon University Gil Medical Center

biomedi@hanmail.net+82-32-460-3201

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026