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The effect of eCOA and portable spirometer use on medication adherence to inhaled medications in patients with asthma

The Impact of eCOA-based Self-Reporting and The Spirokit Device (Portable Spirometer) on the Medication Adherence of Inhaled Drugs in Asthma Patients Undergoing Outpatient Treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011102
Enrollment
16
Registered
2025-11-06
Start date
2025-12-05
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

None listed

Interventions

None listed

Sponsors

Chungnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 years or older at the time of screening. 2) Patients diagnosed with asthma prior to the screening visit. 3) Patients who are willing and able to comply with the study requirements for the entire duration of the trial. 4) Patients who have voluntarily decided to participate after listening to and fully understanding the detailed explanation of this study, and who have provided written informed consent to comply with the precautions.

Exclusion criteria

Exclusion criteria: 1) Patients whose asthma cause or exacerbation factors include environmental factors (allergens (antigens)), infections (e.g., Respiratory syncytial virus (RSV), Human rhinovirus (HRV), Parainfluenza virus, but not limited to), occupational irritants (e.g., Isocyanate, dust, animal-derived allergens, flour, latex, but not limited to), stress, or food. 2) Patients who have been exposed to risk factors for asthma-related mortality: (1) Patients with a lifetime history of one or more intubations and mechanical ventilation treatments due to asthma. (2) Patients who have visited the emergency room (ER) or been hospitalized for acute asthma exacerbation within the last 1 year. (3) Patients who are currently using oral corticosteroids or who have discontinued them within 14 days prior to the first administration date of the inhaled medication. (Does not apply if use was discontinued more than 14 days prior.) (4) Patients with a history of not using inhaled corticosteroids regularly within the last 1 year. (5) Patients who overuse short-acting inhaled beta2-agonists (one or more canisters per month) within the last 1 year, based on the first dosing date after study participation. (6) Patients with concomitant mental health disorders or psychosocial problems, as identified through general history taking and Electronic Medical Record (EMR) review. (7) Patients who have previously been non-adherent to their asthma treatment plan. (This will be assessed via history taking and EMR review, referencing records from the last 1 year. EMR review includes patients who visited the ER for asthma due to medication non-adherence or overuse.) (8) Patients with concomitant food allergies and asthma. (9) Patients with concomitant diseases such as pneumonia, diabetes, or arrhythmia. 3) Patients who are newly starting the following medications (medications that can induce asthma exacerbation) at the time of screening, or are scheduled to start them for the first time during the study period, among those with no prior history of using these drugs: (1) Nonsteroidal anti-inflammatory drugs (NSAIDs) (2) Aspirin (3) Oral or ophthalmic beta-blockers (4) Other drugs that may induce acute asthma exacerbation in the judgment of the principal investigator or delegated co-investigator. 4) Patients who meet the contraindication criteria listed in the precautions for use of their existing inhaled medications (LAMA, LABA, ICS, SABA, and combination products thereof). 5) Patients diagnosed with an acute asthma exacerbation within 30 days of the screening date. 6) Patients who had a change in their asthma medication (for treatment or control) within 3 months prior to the first administration date of the inhaled medication. 7) Patients unable to complete the scheduled visits according to the defined study timeline. 8) Pregnant women, women of childbearing potential, or lactating women. 9) Patients deemed unsuitable for study participation for other reasons, based on the judgment of the principal investigator or a delegated co-investigator.

Design outcomes

Primary

MeasureTime frame
Adherence to inhaled medication during the study period.

Countries

Korea, Republic of

Contacts

Public ContactJung Sunwoo

Chungnam National University Hospital

swj4991@gmail.com+82-42-280-6925

Outcome results

None listed

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