Trial Outcomes & Findings for Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial (NCT NCT02061280)
NCT ID: NCT02061280
Last Updated: 2018-12-19
Results Overview
The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.
COMPLETED
PHASE4
108 participants
Screening (Visit 1, week -8)
2018-12-19
Participant Flow
Participant milestones
| Measure |
MICT Trial Design
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
37
|
|
Overall Study
Randomized to Treatment
|
54
|
25
|
|
Overall Study
COMPLETED
|
53
|
25
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
Reasons for withdrawal
| Measure |
MICT Trial Design
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Overall Study
Protocol Violation
|
12
|
8
|
|
Overall Study
moved out of state
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
Baseline Characteristics
Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
Baseline characteristics by cohort
| Measure |
MICT Trial Design
n=54 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily, or fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14 years
n=5 Participants
|
15 years
n=7 Participants
|
14 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
25 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Unscheduled Health Care Visit in Past 12 Months
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening (Visit 1, week -8)Population: One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6.
The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.
Outcome measures
| Measure |
MICT Trial Design
n=53 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8)
|
41.08 Scores on a scale
Interval 39.48 to 42.69
|
42.26 Scores on a scale
Interval 39.9 to 44.62
|
PRIMARY outcome
Timeframe: Screening (Visit 1, week -8)Population: One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. Thus, the caregiver did not complete the Research Participant Assessment at Visit 6.
The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.
Outcome measures
| Measure |
MICT Trial Design
n=53 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8)
|
43.2 Scores on a scale
Interval 41.96 to 44.45
|
42.9 Scores on a scale
Interval 41.06 to 44.74
|
SECONDARY outcome
Timeframe: Final Visit (Visit 6, Week12)Population: One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6.
The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 6, week 12) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.
Outcome measures
| Measure |
MICT Trial Design
n=53 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12)
|
41.22 Scores on a scale
Interval 39.88 to 42.55
|
41.27 Scores on a scale
Interval 39.29 to 43.25
|
SECONDARY outcome
Timeframe: Final Visit (Visit 6, Week12)Population: One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. Thus, the caregiver did not complete the Research Participant Assessment at Visit 6.
The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 6, week 12) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.
Outcome measures
| Measure |
MICT Trial Design
n=53 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12)
|
43.28 Scores on a scale
Interval 42.33 to 44.23
|
41.08 Scores on a scale
Interval 39.67 to 42.49
|
SECONDARY outcome
Timeframe: Screening (Visit 1, week -8)Population: The participant data set includes all participants who were randomized in each arm, the MICT trial design or LASST trial design. One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. The last available ACT score was used for this participant.
The Asthma Control Test is a 5-item Likert scale questionnaire; Scaling of items 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled); The score for each item is summed to generate a total score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma. The study was powered to have greater than 90% power to detect a clinically meaningful difference of 3 in the ACT score between the MICT Trial Design and the LASST trial Design , assuming a mean score of 19 with a standard deviation of 4 (data from a previous ALA-ACRC trial).
Outcome measures
| Measure |
MICT Trial Design
n=54 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Asthma Control Test Scores at Screening (Visit 1, Week -8)
|
22 scores on a scale
Interval 22.0 to 24.0
|
22 scores on a scale
Interval 21.0 to 23.0
|
SECONDARY outcome
Timeframe: Final Visit (Visit 6, Week 12)Population: The participant data set includes all participants who were randomized in each arm, the MICT trial design or LASST trial design. One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. The last available ACT score was used for this participant.
The Asthma Control Test is a 5-item Likert scale questionnaire; Scaling of items 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled); The score for each item is summed to generate a total score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma. The study was powered to have greater than 90% power to detect a clinically meaningful difference of 3 in the ACT score between the MICT Trial Design and the LASST trial Design , assuming a mean score of 19 with a standard deviation of 4 (data from a previous ALA-ACRC trial).
Outcome measures
| Measure |
MICT Trial Design
n=54 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Asthma Control Test Score at Final Visit (Visit 6, Week12)
|
24 scores on a scale
Interval 22.0 to 25.0
|
23 scores on a scale
Interval 22.0 to 24.0
|
SECONDARY outcome
Timeframe: Visit 3 (week 0)Population: Twenty percent (20%) of available participant scores from Visit 3 (week 0) were randomly selected for analysis; N=11 participant scores were selected from the MICT Trial (20% of 54 scores =11). Eleven (11) participant scores were randomly selected from the LASST trial for analysis.
Spirometry grade scores in MICT participants (who performed spirometry at home) were compared with spirometry grade scores in LASST participants (who performed spirometry at the study sites). Spirometry grade scores were only available for LASST participants at Visit 3 (week 0), therefore only spirometry grade scores from Visit 3 were compared between MICT and LASST participants. Per the LASST trial no scoring was performed on the LASST participants for any other visit; the scoring for the LASST trial was for quality control only and was not a pre-specified trial outcome. Spirometry grade score scale was: 4.00 (highest=best possible score), 3.00, 2.00, 1.00, 0.00 (lowest=worst possible score). The maximum score was 4.00, the minimum score was 0.00. Higher scores indicate better spirometry score and therefore better quality.
Outcome measures
| Measure |
MICT Trial Design
n=11 Participants
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=11 Participants
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Spirometry Quality Control Grade
|
3.75 scores on a scale
Interval 3.75 to 4.0
|
4.00 scores on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: Visit 1 (week -8)Population: No data were collected for this outcome.
This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants. No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 2 (week -4)Population: No data were collected for this outcome.
This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants. No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 3 (week 0)Population: No data were collected for this outcome.
This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants. No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 4 (week 3)Population: No data were collected for this outcome.
This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants. No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 5 (week 6)Population: No data were collected for this outcome.
This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants. No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 6 (week 12)Population: No data were collected for this outcome.
This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants. No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit.
Outcome measures
Outcome data not reported
Adverse Events
MICT Trial Design
LASST Trial Design
Serious adverse events
| Measure |
MICT Trial Design
n=53 participants at risk
MICT Trial:
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 participants at risk
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
acute chest syndrome
|
1.9%
1/53 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/25 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Unsteady gait
|
1.9%
1/53 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/25 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Psychiatric disorders
Suicidality
|
0.00%
0/53 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
4.0%
1/25 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
Other adverse events
| Measure |
MICT Trial Design
n=53 participants at risk
MICT Trial:
Participants randomized to MICT will complete study procedures using an iPad for data entry and FaceTime visits rather than coming into the study site for onsite visits. Participants will perform spirometry at home using a handheld spirometer, EasyOne Plus.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
LASST Trial Design
n=25 participants at risk
Participants randomized to LASST will complete study procedures in the traditional format in which all study visits are conducted at the study site, all questionnaires are completed by pen/paper, and all spirometry is performed at the clinic site.
Randomized to one of 3 study treatments:
fluticasone/salmeterol 250/50 Dry Powder Inhaler one inhalation twice daily fluticasone/salmeterol 100/50 Dry Powder Inhaler one inhalation twice daily fluticasone 100mcg Dry Powder Inhaler one inhalation twice daily
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin bruising
|
5.7%
3/53 • Number of events 4 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/25 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
20.8%
11/53 • Number of events 14 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
12.0%
3/25 • Number of events 3 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
35.8%
19/53 • Number of events 29 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/25 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
17.0%
9/53 • Number of events 13 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
4.0%
1/25 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Chest pain
|
28.3%
15/53 • Number of events 24 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
8.0%
2/25 • Number of events 2 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
54.7%
29/53 • Number of events 48 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
12.0%
3/25 • Number of events 3 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle or joint pain
|
17.0%
9/53 • Number of events 14 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
4.0%
1/25 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
General disorders
Headache
|
41.5%
22/53 • Number of events 43 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
16.0%
4/25 • Number of events 4 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Cardiac disorders
Increased or irregular heartbeat
|
13.2%
7/53 • Number of events 8 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/25 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Restlessness or nervousness
|
11.3%
6/53 • Number of events 12 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/25 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Nervous system disorders
Tremor
|
11.3%
6/53 • Number of events 12 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
0.00%
0/25 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose and congestion
|
45.3%
24/53 • Number of events 45 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
8.0%
2/25 • Number of events 2 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Gastrointestinal disorders
Nausea and/or vomiting
|
17.0%
9/53 • Number of events 10 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
4.0%
1/25 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
1.9%
1/53 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
4.0%
1/25 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
1.9%
1/53 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
4.0%
1/25 • Number of events 1 • The adverse events were recorded starting the visit after treatment randomization at Visit 3 to Visit 6 for a period of 12 weeks in both the MICT and LASST trial.
The data form used to collect adverse events specified specific symptoms that were most likely thought to occur in patients with asthma. In addition, the form listed specific new diagnoses that were thought most likely to occur in the study population. Lastly, the form included 4 fields to list any new symptom or diagnosis that was not previously specified on the form. If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
|
Additional Information
Kathryn Blake, Pharm.D.
Nemours Children's Specialty Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place