Pulmonary DiseaseNCT06108908
Influence of Inhaler Compliance on the Treatment of Asthma Patients
An observational study of Pulmonary Disease and Asthma, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pulmonary Disease, Asthma
- What is being tested?
- Reminder
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Aug 2019to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult asthmatic patients (20-80 years old)
- With mild to moderate persistent asthma according to ATS definition and diagnosis
- Willing to use Budesonide+Formoterol.
- Adequately use inhaler
- Without evident intentional non-adherence
- Agree asthma is a common and potentially serious chronic disease
- Willing to sign Informed Consent Form
Who cannot join
- Inadequately use inhaler
- Disagree asthma is a common and potentially serious chronic disease
- With uncontrolled systemic diseases, such as hypertension, heart failure, renal failure, de-compensated liver cirrhosis, etc.;
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University, Taiwan, R.O.C.
Taipei
+886-66202589 ext. 15313, tmujirb@gmail.com
Han-Pin KUO
About this study
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:
- To increase the adherence rate of treatment by reminder intervention with correctly monitor patients' adherence rate by Asthma Supportive Kits
- 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.
Read the detailed description
- Upon enrollment, the all patients will be educated and equipped with asthma supportive kits, which is a electronic device attaches to an MDI medicine.
- 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.
- 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.
- All the patients adheres with regular asthma treatment mechanism, regardless to group assigned.
- Conditions
- Pulmonary Disease, Asthma
- Being tested
- Reminder
- Medical subject headings
- Lung Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReminderBehavioural
- The reminder is constrained in caring engagement that active engagements, e.g., phone call, or other instant messages, from study nurses to patients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | 1. Patients (compliance rate <80%) received active contact to remind on regular use of medication.
2. The intervention is engaged in caring aspect behavior. None of regular asthma treatment is altered between groups. Receives: Behavioral: Reminder | |
| Control | Patients were not informed regardless to their compliance rate. Receives: Behavioral: Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance ratio
Compliance Ratio:
- the Compliance Ratio evaluates the ratio of days which the patient is taking equal (or greater than) puffs of medicine as instructed by physician with the past 28-days.
- the outcome ratio ranges from 0% (none of days is taking correct amount) to 100% (all past 28 days were taking correct amount).
Measured: 28 day
Asthma Control Test Score
Asthma Control Test (ACT) Score:
- the ACT is a patient self-administrated tool for identifying those with poorly controlled asthma;
- the test includes 5 items to recall past 4-week symptoms and daily functioning;
- The scores range from 5 as poorly controlled to 25 as completely controlled of asthma
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start14 Aug 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Sponsor
- Investigators
- Han-Pin KUO, Principal investigator, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108908
- Sponsor's protocol ID
- N201905051
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Inhaler Compliance on the Treatment of Asthma Patients
- ClinicalTrials.gov ID
- NCT06108908
- Acronym / sponsor ID
- N201905051
- Conditions
- Pulmonary Disease, Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To increase the adherence rate of treatment by reminder intervention with correctly monitor patients' adherence rate by Asthma Supportive Kits
- 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
- Upon enrollment, the all patients will be educated and equipped with asthma supportive kits, which is a electronic device attaches to an MDI medicine.
- 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.
- 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.
- All the patients adheres with regular asthma treatment mechanism, regardless to group assigned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Behavioral: Reminder1. Patients (compliance rate <80%) received active contact to remind on regular use of medication. 2. The intervention is engaged in caring aspect behavior. None of regular asthma treatment is altered between groups. |
| Control | – | Behavioral: ReminderPatients were not informed regardless to their compliance rate. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Adult asthmatic patients (20-80 years old)
- With mild to moderate persistent asthma according to ATS definition and diagnosis
- Willing to use Budesonide+Formoterol.
- Adequately use inhaler
- Without evident intentional non-adherence
Key exclusion criteria (3 listed)
- Inadequately use inhaler
- Disagree asthma is a common and potentially serious chronic disease
- With uncontrolled systemic diseases, such as hypertension, heart failure, renal failure, de-compensated liver cirrhosis, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reminder1. The reminder is constrained in caring engagement that active engagements, e.g., phone call, or other instant messages, from study nurses to patients. | Behavioural | Control, Intervention Group |
Primary outcome
compliance ratio
Time frame: 28 day
Compliance Ratio: 1. the Compliance Ratio evaluates the ratio of days which the patient is taking equal (or greater than) puffs of medicine as instructed by physician with the past 28-days. 2. the outcome ratio ranges from 0% (none of days is taking correct amount) to 100% (all past 28 days were taking correct amount).
Asthma Control Test Score
Time frame: 28 day
Asthma Control Test (ACT) Score: 1. the ACT is a patient self-administrated tool for identifying those with poorly controlled asthma; 2. the test includes 5 items to recall past 4-week symptoms and daily functioning; 3. The scores range from 5 as poorly controlled to 25 as completely controlled of asthma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han-Pin KUO principal investigator
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease and Asthma, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-Pin KUO (+886975368066, hpk8828@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance ratio (time frame: 28 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.