Adults 6 to 17, any sex, with Asthma in Children. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Composite Asthma Severity Index (CASI)Primary· Baseline to 12 months
CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).
\[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity\]
V1
Group
Value
95% CI
Personalized Treatment
5
5 – 6
V2
Group
Value
95% CI
Personalized Treatment
5
5 – 5
V3
Group
Value
95% CI
Personalized Treatment
5
5 – 5
Asthma Control Test (ACT)Secondary· Baseline to 12 months
ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).
\[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma\]
V1
Group
Value
95% CI
Personalized Treatment
23.0
20.0 – 23.0
V2
Group
Value
95% CI
Personalized Treatment
21.7
18.2 – 24.2
V3
Group
Value
95% CI
Personalized Treatment
22.5
18.2 – 24.2
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)Secondary· Baseline to 12 months
FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.
\[A lower FEV1/FVC ratio indicates more severe asthma\]
V1
Group
Value
95% CI
Personalized Treatment
0.81
0.76 – 0.86
V2
Group
Value
95% CI
Personalized Treatment
0.8
0.76 – 0.85
V3
Group
Value
95% CI
Personalized Treatment
0.8
0.77 – 0.87
Adherence of Asthma Controller MedicationSecondary· Baseline to 12 months
Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months).
V1
Group
Value
95% CI
Personalized Treatment
42
21 – 57
V3
Group
Value
95% CI
Personalized Treatment
36
14 – 53
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
Last refreshed: 20 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04179461.