Trial Outcomes & Findings for Supervised Asthma Medication in Schools (SAMS) (NCT NCT01997463)
NCT ID: NCT01997463
Last Updated: 2022-03-23
Results Overview
An ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
442 participants
Primary outcome timeframe
1 year
Results posted on
2022-03-23
Participant Flow
Participant milestones
| Measure |
Regular Therapy
Regular Asthma Therapy
|
Supervised Therapy
Supervised asthma therapy in schools
Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
250
|
|
Overall Study
COMPLETED
|
107
|
147
|
|
Overall Study
NOT COMPLETED
|
85
|
103
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Supervised Asthma Medication in Schools (SAMS)
Baseline characteristics by cohort
| Measure |
Regular Therapy
n=192 Participants
Regular Asthma Therapy
|
Supervised Therapy
n=250 Participants
Supervised asthma therapy in schools
Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association
|
Total
n=442 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
192 Participants
n=99 Participants
|
250 Participants
n=107 Participants
|
442 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
282 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
128 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
296 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
62 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearAn ACQ score of \> 1.5 means asthma is not well controlled. An ACQ score of \<= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ
Outcome measures
| Measure |
Regular Therapy
n=192 Participants
Regular Asthma Therapy
|
Supervised Therapy
n=250 Participants
Supervised asthma therapy in schools
Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association
|
|---|---|---|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 2 · missing ACQ score
|
61 Participants
|
78 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 1 · ACQ score >1.5 (not well controlled)
|
54 Participants
|
70 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 1 · ACQ score <=1.5(well controlled)
|
74 Participants
|
95 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 1 · missing ACQ score
|
64 Participants
|
85 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 2 · ACQ score >1.5 (not well controlled)
|
56 Participants
|
73 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 2 · ACQ score <=1.5(well controlled)
|
75 Participants
|
99 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 3 · ACQ score >1.5 (not well controlled)
|
55 Participants
|
65 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 3 · ACQ score <=1.5(well controlled)
|
75 Participants
|
116 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 3 · missing ACQ score
|
62 Participants
|
69 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 4 · ACQ score >1.5 (not well controlled)
|
60 Participants
|
65 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 4 · ACQ score <=1.5(well controlled)
|
77 Participants
|
123 Participants
|
|
The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ)
Visit 4 · missing ACQ score
|
55 Participants
|
62 Participants
|
Adverse Events
Regular Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supervised Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place