Clinical trial NCT06108908: Influence of Inhaler Compliance on the Treatment of Asthma Patients
Official title: Influence of Inhaler Compliance on the Treatment of Asthma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease
Asthma
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University
First posted: 2023-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult asthmatic patients (20-80 years old) with mild to moderate persistent asthma according to ATS definition and diagnosis. Agree asthma is a common and potentially serious chronic disease.

Brief summary: The major goal of "Influence of Inhaler Compliance on the Treatment of Asthma Patients" is to explore compliance rate outcome in adult asthmatic patients (20-80 years old) with mild to moderate persistent asthma according to American Thoracic Society (ATS) definition and diagnosis. The major endpoints include:

1. To increase the adherence rate of treatment by reminder intervention with correctly monitor patients' adherence rate by Asthma Supportive Kits
2. Eventually achieve best asthma care and management.

All participants will use Asthma Supportive Kits for 24 weeks and return visit on week 5, 12, 24. Based on collected data, the study compares intervention and control group to see if active reminder intervention may effectively alter compliance rate, and corresponding outcomes, e.g., asthma control status, acute exacerbation events.

Detailed description: 1. Upon enrollment, the all patients will be educated and equipped with asthma supportive kits, which is a electronic device attaches to an MDI medicine.
2. The asthma supportive kit registers every puff taken when the patient uses his/her MDI. The records are monitored by study nurses and calculated compliance ratio on rolling basis.
3. By enrollment, the patient is RANDOMLY assigned to Intervention and Control group. For the Intervention group in each study phases, when the given compliance ratio drops below 80% (as monitored by asthma supportive kit), the study nurse will actively engage to remind on medicine taking. For the Control group, the compliance ratio is calculated but to active engagement is applied.
4. All the patients adheres with regular asthma treatment mechanism, regardless to group assigned.

Eligibility criteria: Inclusion Criteria:

1. Adult asthmatic patients (20-80 years old)
2. With mild to moderate persistent asthma according to ATS definition and diagnosis
3. Willing to use Budesonide+Formoterol.
4. Adequately use inhaler
5. Without evident intentional non-adherence
6. Agree asthma is a common and potentially serious chronic disease
7. Willing to sign Informed Consent Form

Exclusion Criteria:

1. Inadequately use inhaler
2. Disagree asthma is a common and potentially serious chronic disease
3. With uncontrolled systemic diseases, such as hypertension, heart failure, renal failure, de-compensated liver cirrhosis, etc.;

Primary outcomes:
measure: compliance ratio
timeFrame: 28 day
measure: Asthma Control Test Score
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University, Taiwan, R.O.C.
Study officials:
affiliation: Taipei Medical University, Taiwan, R.O.C.
name: Han-Pin KUO
role: PRINCIPAL_INVESTIGATOR
References: