Trial Outcomes & Findings for School-based Asthma Therapy: Stage 2 Effectiveness Study (NCT NCT01175369)

Results Overview

The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

530 participants

Primary outcome timeframe

Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)

Results posted on

2014-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Usual asthma care	School-based Care The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Overall Study STARTED	265	265
Overall Study COMPLETED	263	260
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

School-based Asthma Therapy: Stage 2 Effectiveness Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=265 Participants Usual asthma care	School-based Care n=265 Participants The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).	Total n=530 Participants Total of all reporting groups
Age, Categorical <=18 years	265 Participants n=93 Participants	265 Participants n=4 Participants	530 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	7.2 years STANDARD_DEVIATION 1.9 • n=93 Participants	7.1 years STANDARD_DEVIATION 2.0 • n=4 Participants	7.1 years STANDARD_DEVIATION 1.9 • n=27 Participants
Sex: Female, Male Female	118 Participants n=93 Participants	104 Participants n=4 Participants	222 Participants n=27 Participants
Sex: Female, Male Male	147 Participants n=93 Participants	161 Participants n=4 Participants	308 Participants n=27 Participants
Region of Enrollment United States	265 participants n=93 Participants	265 participants n=4 Participants	530 participants n=27 Participants

PRIMARY outcome

Timeframe: Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)

The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).

Outcome measures

Outcome measures
Measure	Usual Care n=263 Participants Usual asthma care	School-based Care n=260 Participants The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Number of Symptom Free Days	10.7 Days Standard Deviation 3.1	11.6 Days Standard Deviation 2.5

SECONDARY outcome

Timeframe: 2 month and approximately 9 month (end of school year) follow-up assessments

To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approximately 9 months (length of school year)

Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1-9 months (Monthly Follow-up assessments)

We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.

Outcome measures

Outcome data not reported

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

School-based Care

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

Dr. Jill Halterman

University of Rochester

Phone: 5852755798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place