Asthma in ChildrenNCT04228107
Treatment Phenotypes for Adolescents With Asthma
A study testing Medication monitoring in people with Asthma in Children and Adherence, Treatment, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will evaluate how adolescents take their asthma medications using an electronic medication monitor. Read more about this study
- Who is it for?
- Ages 12 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Adherence, Treatment
- What is being tested?
- Medication monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 14 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of asthma On an inhaled controller and rescue medication for which a propeller health device is available
Who cannot join
- Other significant chronic lung disease (from problem list)
- Cystic fibrosis
- Chronic respiratory failure
- Tracheostomy status
- Intersititial lung disease
- Significant developmental delay
Show all 9Show fewer
- Taking more than 3 asthma related medications
- Primary language other than English, Spanish, Catalan, Dutch, French, German or Italian
- Healthcare providers will be recruited as well to participate in focus groups as part of specific aim 2.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.
Read the detailed description
This study will look at how adolescents use both their controller and rescue medications using an electronic medication monitoring platform, for the period of one year. Participants will be enrolled in a medication monitoring platform, and their asthma care provider will have access to medication usage information. The study team will collect data on medication use patterns in a real world setting for 12 months per participant. Additionally, healthcare providers will be enrolled in focus groups to determine barriers and facilitators to optimal medication use for their patients.
- Conditions
- Asthma in Children, Adherence, Treatment
- Being tested
- Medication monitoring
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication monitoringDevice
This is an observational study of medication use patterns. The propeller health device has reminders for controller medication use and gives feedback regarding medication use to the participant, their guardian and their asthma provider
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Participants will be enrolled in medication use monitoring. Their medication use patterns will be available to themselves and their guardians via a smartphone application, and to their asthma care providers via a portal. There will be no interventions to change medication use patterns. A portion of them will be asked to participate in a semistructured interview during which they will be asked questions about their perception of their asthma, health beliefs regarding medication use, and what they feel would be the most helpful to get them to take their asthma medicines.
Additionally a small group of healthcare providers will be asked to participate in a focus group to collect qualitative data on medication use barriers and facilitators Receives: Device: Medication monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Phenotypes
The Investigators will calculate the number of participants that fall into the following treatment phenotypes: "Well controlled-good adherence", "Well controlled-poor adherence", "Poorly controlled-good adherence", "Poorly controlled-poor adherence".
We had initially planned to report only these 4 groups, however there was a very clear breakdown into 9 groups-as we needed to consider a moderately controlled group and a moderately adherent group. Therefore the groups are reported as follows:
Poor Adhrence, Poor control Poor adherence, moderate control poor adherence, good control
Moderate adherence, poor control moderate adherence, moderate control moderate adherence, good control
good adherence, poor control good adherence, moderate control good adherence, good control
The investigators will use group based trajectory modeling to evaluate adherence and control phenotypes
Measured: 12 months
Secondary outcomes (4)
Qualitative Information Regarding Barriers for Medication Use
Qualitative data (semistructured interviews with patients regarding barriers to medication use.
Measured: 12 months
Qualitative Information Regarding Facilitators for Medication Use
Qualitative data (semistructured interviews with adolescents) regarding barriers to medication use.
Measured: 12 months
Qualitative Information Regarding Facilitators for Medication Use
Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.
Measured: 12 months
Qualitative Information Regarding Barriers for Medication Use
Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start16 Nov 2020
- Primary completion14 Jul 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather EH De Keyser, MD MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228107
- Sponsor's protocol ID
- 19-1861
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2020
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Phenotypes for Adolescents With Asthma
- ClinicalTrials.gov ID
- NCT04228107
- Acronym / sponsor ID
- 19-1861
- Conditions
- Asthma in Children, Adherence, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Posted 6 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.
Detailed description
This study will look at how adolescents use both their controller and rescue medications using an electronic medication monitoring platform, for the period of one year. Participants will be enrolled in a medication monitoring platform, and their asthma care provider will have access to medication usage information. The study team will collect data on medication use patterns in a real world setting for 12 months per participant. Additionally, healthcare providers will be enrolled in focus groups to determine barriers and facilitators to optimal medication use for their patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Device: Medication monitoringParticipants will be enrolled in medication use monitoring. Their medication use patterns will be available to themselves and their guardians via a smartphone application, and to their asthma care providers via a portal. There will be no interventions to change medication use patterns. A portion of them will be asked to participate in a semistructured interview during which they will be asked questions about their perception of their asthma, health beliefs regarding medication use, and what they feel would be the most helpful to get them to take their asthma medicines. Additionally a small group of healthcare providers will be asked to participate in a focus group to collect qualitative data on medication use barriers and facilitators |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of asthma On an inhaled controller and rescue medication for which a propeller health device is available
Key exclusion criteria (9 listed)
- Other significant chronic lung disease (from problem list)
- Significant developmental delay
- Taking more than 3 asthma related medications
- Primary language other than English, Spanish, Catalan, Dutch, French, German or Italian
- Healthcare providers will be recruited as well to participate in focus groups as part of specific aim 2.
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 |
|---|---|---|
| Medication monitoringThis is an observational study of medication use patterns. The propeller health device has reminders for controller medication use and gives feedback regarding medication use to the participant, their guardian and their asthma provider | Device | Cohort |
Primary outcome
Treatment Phenotypes
Time frame: 12 months
The Investigators will calculate the number of participants that fall into the following treatment phenotypes: "Well controlled-good adherence", "Well controlled-poor adherence", "Poorly controlled-good adherence", "Poorly controlled-poor adherence". We had initially planned to report only these 4 groups, however there was a very clear breakdown into 9 groups-as we needed to consider a moderately controlled group and a moderately adherent group. Therefore the groups are reported as follows: Poor Adhrence, Poor control Poor adherence, moderate control poor adherence, good control Moderate adherence, poor control moderate adherence, moderate control moderate adherence, good control good adherence, poor control good adherence, moderate control good adherence, good control The investigators will use group based trajectory modeling to evaluate adherence and control phenotypes
4 secondary outcomes
Qualitative Information Regarding Barriers for Medication Use
Time frame: 12 months
Qualitative Information Regarding Facilitators for Medication Use
Time frame: 12 months
Qualitative Information Regarding Facilitators for Medication Use
Time frame: 12 months
Qualitative Information Regarding Barriers for Medication Use
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Heather EH De Keyser, MD MS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication monitoring in people with Asthma in Children and Adherence, Treatment, run by University of Colorado, Denver at 1 site in United States.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 6 Nov 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Phenotypes (time frame: 12 months). 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 6 Nov 2025.