Trial Outcomes & Findings for Treatment Phenotypes for Adolescents With Asthma (NCT NCT04228107)

Last Updated: 2025-11-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

12 months

Results posted on

2025-11-06

Participant Flow

70 adolescent participants were enrolled for the primary aim. 10 healthcare providers were enrolled to participate in focus groups.

Participant milestones

Participant milestones
Measure	Adolescents With Medication Monitoring 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.	Healthcare Provider Focus Groups Healthcare providers will be enrolled in focus groups to discuss medication adherence in teens. Healthcare provider demographics were not collected as part of focus group participation.
Overall Study STARTED	70	10
Overall Study Completed a Qualitative Semistructured Interview (Subset)	21	0
Overall Study COMPLETED	43	10
Overall Study NOT COMPLETED	27	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Adolescents With Medication Monitoring 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.	Healthcare Provider Focus Groups Healthcare providers will be enrolled in focus groups to discuss medication adherence in teens. Healthcare provider demographics were not collected as part of focus group participation.
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	6	0
Overall Study Lost to Follow-up	18	0
Overall Study No controller use data	1	0
Overall Study No medication data collected	1	0

Baseline Characteristics

Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adolescents n=43 Participants Teens enrolled for electronic medication monitoring. 43 participants completed at least 11 months of medication monitoring and were included in the final analysis
Age, Continuous	13.8 years STANDARD_DEVIATION 1.34 • n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Sex: Female, Male Female	14 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Sex: Female, Male Male	29 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Race (NIH/OMB) Asian	1 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Race (NIH/OMB) Black or African American	5 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Race (NIH/OMB) White	25 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Race (NIH/OMB) More than one race	2 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.
FEV1 Z score	0.18 Z score n=49 Participants • Only participants with greater than 11 months (47 weeks) of synced data were included in the final analysis. Those not included had less than 47 weeks of data synced from the sensors.

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Adolescents n=43 Participants Adolescents enrolled in 1 year of electronic medication monitoring. During the study, participants had less than 1 year of data completed from the sensors for a number of reasons (most often that their device stopped syncing with the app and we were unable to re-establish a connection). Only participants with greater than 11 months of data collected were included in the final analysis. N=25 participants were excluded from the final analysis for not having a full 11+ months worth of data. Therefore the final analytic population was 45 participants.
Treatment Phenotypes Poor adherence, good control	7 Participants
Treatment Phenotypes poor adherence, poor control	2 Participants
Treatment Phenotypes Moderate adherence, good control	10 Participants
Treatment Phenotypes moderate adherence, poor control	5 Participants
Treatment Phenotypes high adherence, good control	16 Participants
Treatment Phenotypes high adherence, poor control	3 Participants

SECONDARY outcome

Timeframe: 12 months

Qualitative data (semistructured interviews with patients regarding barriers to medication use.

Outcome measures

Outcome measures
Measure	Adolescents n=21 Participants Adolescents enrolled in 1 year of electronic medication monitoring. During the study, participants had less than 1 year of data completed from the sensors for a number of reasons (most often that their device stopped syncing with the app and we were unable to re-establish a connection). Only participants with greater than 11 months of data collected were included in the final analysis. N=25 participants were excluded from the final analysis for not having a full 11+ months worth of data. Therefore the final analytic population was 45 participants.
Qualitative Information Regarding Barriers for Medication Use Theme: poor routine	8 Participants
Qualitative Information Regarding Barriers for Medication Use Theme: forget	3 Participants

SECONDARY outcome

Timeframe: 12 months

Qualitative data (semistructured interviews with adolescents) regarding barriers to medication use.

Outcome measures

Outcome measures
Measure	Adolescents n=21 Participants Adolescents enrolled in 1 year of electronic medication monitoring. During the study, participants had less than 1 year of data completed from the sensors for a number of reasons (most often that their device stopped syncing with the app and we were unable to re-establish a connection). Only participants with greater than 11 months of data collected were included in the final analysis. N=25 participants were excluded from the final analysis for not having a full 11+ months worth of data. Therefore the final analytic population was 45 participants.
Qualitative Information Regarding Facilitators for Medication Use Theme: habit	7 Participants
Qualitative Information Regarding Facilitators for Medication Use Theme: parental reminders	8 Participants
Qualitative Information Regarding Facilitators for Medication Use Theme: good routine	12 Participants

SECONDARY outcome

Timeframe: 12 months

Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.

Outcome measures

Outcome measures
Measure	Adolescents n=10 Participants Adolescents enrolled in 1 year of electronic medication monitoring. During the study, participants had less than 1 year of data completed from the sensors for a number of reasons (most often that their device stopped syncing with the app and we were unable to re-establish a connection). Only participants with greater than 11 months of data collected were included in the final analysis. N=25 participants were excluded from the final analysis for not having a full 11+ months worth of data. Therefore the final analytic population was 45 participants.
Qualitative Information Regarding Facilitators for Medication Use Theme: tailored approach	7 Participants
Qualitative Information Regarding Facilitators for Medication Use Theme: buy in from patient/family	5 Participants

SECONDARY outcome

Timeframe: 12 months

Qualitative data (focus groups with healthcare providers) to determine facilitators to medication use.

Outcome measures

Outcome measures
Measure	Adolescents n=10 Participants Adolescents enrolled in 1 year of electronic medication monitoring. During the study, participants had less than 1 year of data completed from the sensors for a number of reasons (most often that their device stopped syncing with the app and we were unable to re-establish a connection). Only participants with greater than 11 months of data collected were included in the final analysis. N=25 participants were excluded from the final analysis for not having a full 11+ months worth of data. Therefore the final analytic population was 45 participants.
Qualitative Information Regarding Barriers for Medication Use Theme: insurance/cost barriers	5 Participants
Qualitative Information Regarding Barriers for Medication Use Theme: lack of adolescent understanding or prioritization	7 Participants
Qualitative Information Regarding Barriers for Medication Use Theme: lack of parental involvement or parenting challenges	5 Participants

Adverse Events

Adolescents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather De Keyser MD MSCS

University of Colorado

Phone: 720-777-4108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place