Trial Outcomes & Findings for Personalized Treatment Algorithms for Difficult-to-treat Asthma (NCT NCT04179461)

Last Updated: 2021-08-20

Results Overview

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). \[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity\]

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Baseline to 12 months

Results posted on

2021-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Personalized Treatment Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Personalized Treatment Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Overall Study Lost to Follow-up	4

Baseline Characteristics

Personalized Treatment Algorithms for Difficult-to-treat Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Personalized Treatment n=20 Participants Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	12.4 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants
Primary home within a 40 mile radius of Cincinnati Children's Base Location	20 Participants n=5 Participants
Health insurance coverage at enrollment	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: 17 participants whom had complete data sets were analyzed. 4 participants withdrew early from the study and were not included in this analysis due to incomplete data.

Outcome measures

Outcome measures
Measure	Personalized Treatment n=17 Participants Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Change in Composite Asthma Severity Index (CASI) V1	5 score on a scale Interval 5.0 to 6.0
Change in Composite Asthma Severity Index (CASI) V2	5 score on a scale Interval 5.0 to 5.0
Change in Composite Asthma Severity Index (CASI) V3	5 score on a scale Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: 17 participants whom had complete data sets were analyzed. 4 participants withdrew early from the study and were not included in this analysis due to incomplete data.

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). \[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma\]

Outcome measures

Outcome measures
Measure	Personalized Treatment n=17 Participants Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Asthma Control Test (ACT) V1	23.0 score on a scale Interval 20.0 to 23.0
Asthma Control Test (ACT) V2	21.7 score on a scale Interval 18.2 to 24.2
Asthma Control Test (ACT) V3	22.5 score on a scale Interval 18.2 to 24.2

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: 17 participants whom had complete data sets were analyzed. 4 participants withdrew early from the study and were not included in this analysis due to incomplete data.

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. \[A lower FEV1/FVC ratio indicates more severe asthma\]

Outcome measures

Outcome measures
Measure	Personalized Treatment n=17 Participants Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC) V1	0.81 Ratio Interval 0.76 to 0.86
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC) V2	0.8 Ratio Interval 0.76 to 0.85
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC) V3	0.8 Ratio Interval 0.77 to 0.87

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: 16 participants whom had complete data sets were analyzed.

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).

Outcome measures

Outcome measures
Measure	Personalized Treatment n=16 Participants Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Adherence of Asthma Controller Medication V1	42 percentage of medication taken Interval 21.0 to 57.0
Adherence of Asthma Controller Medication V3	36 percentage of medication taken Interval 14.0 to 53.0

Adverse Events

Personalized Treatment

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Personalized Treatment n=21 participants at risk Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Psychiatric disorders Major Depressive Disorder	4.8% 1/21 • Number of events 1 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.
Psychiatric disorders Psychiatric Evaluation	4.8% 1/21 • Number of events 2 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.

Other adverse events

Other adverse events
Measure	Personalized Treatment n=21 participants at risk Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention. Cholecalciferol: Oral administration antihistamine: Oral administration Azithromycin: Oral administration emollient cream: Topical Fluticasone Propionate: Nasal spray Asthma Controller Medication: Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Respiratory, thoracic and mediastinal disorders Asthma Exacerbation	38.1% 8/21 • Number of events 12 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.
Musculoskeletal and connective tissue disorders Ankle Injury	9.5% 2/21 • Number of events 2 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.
Infections and infestations Influenza	9.5% 2/21 • Number of events 2 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.
Infections and infestations Streptococcal Pharyngitis	14.3% 3/21 • Number of events 3 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.
Infections and infestations Viral Gastroenteritis	9.5% 2/21 • Number of events 2 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.
Infections and infestations Sinusitis	4.8% 1/21 • Number of events 2 • 1 year Review for possible adverse events was completed at study visits and follow-up phone calls by the research coordinator. If adverse events were identified, they were documented on the Adverse Event Reporting Form and reviewed at the meeting of the Steering committee.

Additional Information

Theresa Guilbert, MD, MS

Cincinnati Children's Hospital Medical Center

Phone: (513) 636-6771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place