AsthmaPhase 4MICTNCT02061280
Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
A Phase 4 study testing fluticasone/salmeterol 250/50 Dry Powder Inhaler, fluticasone/salmeterol 100/50 Dry Powder Inhaler and fluticasone 100mcg Dry Powder Inhaler in people with Asthma, run by Nemours Children's Clinic at 5 sites in United States.
Trial summary
Asthma is an inflammatory disease that imposes a significant burden affecting an estimated 300 million persons and 20% of all children worldwide. It is one of the most common chronic diseases of childhood and is a leading cause of school absenteeism. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- fluticasone/salmeterol 250/50 Dry Powder Inhaler, fluticasone/salmeterol 100/50 Dry Powder Inhaler and fluticasone 100mcg Dry Powder Inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2013to 17 Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12-17 years
- Physician diagnosed asthma (without any other co-morbid pulmonary disease) that is well-controlled on medium dose inhaled corticosteroid and long-acting β2-agonist given twice daily [Advair Diskus (fluticasone propionate/salmeterol) 250/50mcg; Advair HFA (hydrofluoroalkane) (fluticasone propionate/salmeterol hydrofluoroalkane) 115/21mcg; Symbicort (budesonide/formoterol) 160/4.5mcg; Dulera (mometasone/formoterol) 100/4.5mcg] based on an ACT score > 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment
- Pre-bronchodilator forced expiratory volume in the first second > 70% predicted
- < 10 pack/year history of tobacco use and abstinence for at least 1 year
- Age 12-17 years
- Physician diagnosed asthma (without any other co-morbid pulmonary disease) that is well-controlled on medium dose inhaled corticosteroid and long-acting β2-agonist given twice daily [Advair Diskus (fluticasone propionate/salmeterol) 250/50mcg; Advair HFA (hydrofluoroalkane) (fluticasone propionate/salmeterol hydrofluoroalkane) 115/21mcg; Symbicort (budesonide/formoterol) 160/4.5mcg; Dulera (mometasone/formoterol) 100/4.5mcg] based on an ACT score > 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment
- < 10 pack/year history of tobacco use and abstinence for at least 1 year
Who cannot join
- Chronic oral steroid therapy
- Hospitalization or urgent care visit within 4 weeks of the screening visit
- Near fatal asthma within 2 years of enrollment or high risk of near fatal or fatal asthma 125-127
- Women who are pregnant or lactating
- Parallel MICT and Parallel LASST
- Chronic oral steroid therapy
Show all 9Show fewer
- Hospitalization or urgent care visit within 4 weeks of the screening visit
- Near fatal asthma within 2 years of enrollment or high risk of near fatal or fatal asthma 125-127
- Women who are pregnant or lactating
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
Nemours Children's Hospital
Orlando, Florida, 32806
Nemours Children's Specialty Care
Pensacola, Florida, 32504
Washington University in St. Louis
St Louis, Missouri, 63130
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Asthma is an inflammatory disease that imposes a significant burden affecting an estimated 300 million persons and 20% of all children worldwide. It is one of the most common chronic diseases of childhood and is a leading cause of school absenteeism. There continues to be a great need for clinical trials in asthma but traditional clinical trials are expensive and reasons cited by patients for non-participation are extra inconvenience and logistical barriers. Study designs which are patient centered and reduce trial costs are needed. The long-range goal of this application is to transform the paradigm of clinical research into a more efficient and cost-effective enterprise by capitalizing upon current widely used mobile electronic means of communication and information transfer.
This innovative project is a streamlined clinical trial that will run concurrently with a nearly identical traditional clinical trial, "Long-acting Beta Agonist Step Down Study" (LASST) which will allow for direct comparison of processes and outcomes between the streamlined and traditional approach. Children 12 to 17 years old with asthma will be randomized to participate in this project (streamlined trial) or LASST (traditional trial). In this proposal we will: measure comprehension of study information using an original questionnaire, Research Participant Assessment (developed at Nemours), following a parental permission/assent process delivered over the internet in a dynamic interactive multi-media format (Specific Aim 1); measure the efficiency of participant driven data entry from home into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad (Specific Aim 2); test whether the streamlined approach has a "trial effect" by comparing the differences in Asthma Control Test (ACT) scores following 12 weeks of study drug treatment in children randomized to this project compared to LASST. We will collect effort reporting data to compare personnel costs between the trials. If this streamlined project lacks a "trial effect" and reduces costs compared to LASST, the methodologies would be generalizable to studies which include adults and other diseases.
Read the detailed description
Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial.
Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi (wireless internet) and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs.
Results Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing.
Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.
- Conditions
- Asthma
- Being tested
- fluticasone/salmeterol 250/50 Dry Powder Inhaler, fluticasone/salmeterol 100/50 Dry Powder Inhaler, fluticasone 100mcg Dry Powder Inhaler
- Keywords
- Asthma, Clinical Trial Design, Electronic Data Entry, Mobile Devices, Home Spirometry
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone/salmeterol 250/50 Dry Powder InhalerDrug
Also called Advair Diskus
Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization
fluticasone/salmeterol 100/50 Dry Powder InhalerDrug
Also called Advair Diskus
Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization
fluticasone 100mcg Dry Powder InhalerDrug
Also called Flovent Diskus
Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization
| Study group | Role | What they receive |
|---|---|---|
| MICT Trial Design | Experimental | 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 Receives: Drug: fluticasone/salmeterol 250/50 Dry Powder Inhaler; Drug: fluticasone/salmeterol 100/50 Dry Powder Inhaler; Drug: fluticasone 100mcg Dry Powder Inhaler |
| LASST Trial Design | Active comparator | 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. Receives: Drug: fluticasone/salmeterol 250/50 Dry Powder Inhaler; Drug: fluticasone/salmeterol 100/50 Dry Powder Inhaler; Drug: fluticasone 100mcg Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8)
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.
Measured: Screening (Visit 1, week -8)
Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8)
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.
Measured: Screening (Visit 1, week -8)
Secondary outcomes (11)
Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12)
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.
Measured: Final Visit (Visit 6, Week12)
Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12)
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.
Measured: Final Visit (Visit 6, Week12)
Asthma Control Test Scores at Screening (Visit 1, Week -8)
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).
Measured: Screening (Visit 1, week -8)
Asthma Control Test Score at Final Visit (Visit 6, Week12)
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).
Measured: Final Visit (Visit 6, Week 12)
Spirometry Quality Control Grade
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.
Measured: Visit 3 (week 0)
Number of Errors in Questionnaires Completed by Participants at Visit 1 (Week -8).
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.
Measured: Visit 1 (week -8)
Number of Errors in Questionnaires Completed by Participants at Visit 2 (Week -4).
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.
Measured: Visit 2 (week -4)
Number of Errors in Questionnaires Completed by Participants at Visit 3 (Week 0).
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.
Measured: Visit 3 (week 0)
Number of Errors in Questionnaires Completed by Participants at Visit 4 (Week 3).
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.
Measured: Visit 4 (week 3)
Number of Errors in Questionnaires Completed by Participants at Visit 5 (Week 6).
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.
Measured: Visit 5 (week 6)
Number of Errors in Questionnaires Completed by Participants at Visit 6 (Week 12).
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.
Measured: Visit 6 (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startOct 2013
- Primary completion17 Feb 2017
- Study completion17 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kathryn Blake, PharmD, Principal investigator, Nemours Children's Clinic Jacksonville FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061280
- Sponsor's protocol ID
- 332965
- Other IDs
- R01HL114899
- Acronym
- MICT
- Status last verified
- Nov 2018
- First submitted
- 31 Jan 2014
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified datasets, study forms, study protocol, study manual of procedures will be deposited into BioLINCC.
Publications
Blake K, Holbrook JT, Antal H, Shade D, Bunnell HT, McCahan SM, Wise RA, Pennington C, Garfinkel P, Wysocki T. Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale. Contemp Clin Trials. 2015 May;42:105-18. doi: 10.1016/j.cct.2015.03.012. Epub 2015 Apr 3.
PubMed 25847579Antal H, Bunnell HT, McCahan SM, Pennington C, Wysocki T, Blake KV. A cognitive approach for design of a multimedia informed consent video and website in pediatric research. J Biomed Inform. 2017 Feb;66:248-258. doi: 10.1016/j.jbi.2017.01.011. Epub 2017 Jan 19.
PubMed 28109951Blake KV, Antal H, Bunnell HT, He J, Henderson R, Holbrook JT, McCahan SM, Pennington C, Rogers L, Shade D, Sugar EA, Taylor A, Wise RA, Wysocki T. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. JMIR Pediatr Parent. 2023 Jun 22;6:e44252. doi: 10.2196/44252.
PubMed 37347518
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
- ClinicalTrials.gov ID
- NCT02061280
- Acronym / sponsor ID
- MICT / 332965
- Conditions
- Asthma
- Keywords
- Asthma, Clinical Trial Design, Electronic Data Entry, Mobile Devices, Home Spirometry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2013
- Primary completion
- 17 Feb 2017 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 18 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is an inflammatory disease that imposes a significant burden affecting an estimated 300 million persons and 20% of all children worldwide. It is one of the most common chronic diseases of childhood and is a leading cause of school absenteeism. There continues to be a great need for clinical trials in asthma but traditional clinical trials are expensive and reasons cited by patients for non-participation are extra inconvenience and logistical barriers. Study designs which are patient centered and reduce trial costs are needed. The long-range goal of this application is to transform the paradigm of clinical research into a more efficient and cost-effective enterprise by capitalizing upon current widely used mobile electronic means of communication and information transfer.
This innovative project is a streamlined clinical trial that will run concurrently with a nearly identical traditional clinical trial, "Long-acting Beta Agonist Step Down Study" (LASST) which will allow for direct comparison of processes and outcomes between the streamlined and traditional approach. Children 12 to 17 years old with asthma will be randomized to participate in this project (streamlined trial) or LASST (traditional trial). In this proposal we will: measure comprehension of study information using an original questionnaire, Research Participant Assessment (developed at Nemours), following a parental permission/assent process delivered over the internet in a dynamic interactive multi-media format (Specific Aim 1); measure the efficiency of participant driven data entry from home into a Research Electronic Data Capture (REDCap) online database using the iPad, and quality of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad (Specific Aim 2); test whether the streamlined approach has a "trial effect" by comparing the differences in Asthma Control Test (ACT) scores following 12 weeks of study drug treatment in children randomized to this project compared to LASST. We will collect effort reporting data to compare personnel costs between the trials. If this streamlined project lacks a "trial effect" and reduces costs compared to LASST, the methodologies would be generalizable to studies which include adults and other diseases.
Detailed description
Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial.
Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi (wireless internet) and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs.
Results Participants have been enrolled in the streamlined and traditional trials and recruitment is ongoing.
Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MICT Trial Design | Experimental | Drug: fluticasone/salmeterol 250/50 Dry Powder Inhaler, Drug: fluticasone/salmeterol 100/50 Dry Powder Inhaler, Drug: fluticasone 100mcg Dry Powder InhalerParticipants 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 | Active comparator | Drug: fluticasone/salmeterol 250/50 Dry Powder Inhaler, Drug: fluticasone/salmeterol 100/50 Dry Powder Inhaler, Drug: fluticasone 100mcg Dry Powder InhalerParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 12-17 years
- Physician diagnosed asthma (without any other co-morbid pulmonary disease) that is well-controlled on medium dose inhaled corticosteroid and long-acting β2-agonist given twice daily [Advair Diskus (fluticasone propionate/salmeterol) 250/50mcg; Advair HFA (hydrofluoroalkane) (fluticasone propionate/salmeterol hydrofluoroalkane) 115/21mcg; Symbicort (budesonide/formoterol) 160/4.5mcg; Dulera (mometasone/formoterol) 100/4.5mcg] based on an ACT score > 20, and the absence of unscheduled visits or use of rescue prednisone for 4 weeks prior to enrollment
- Pre-bronchodilator forced expiratory volume in the first second > 70% predicted
- < 10 pack/year history of tobacco use and abstinence for at least 1 year
- Age 12-17 years
Key exclusion criteria (9 listed)
- Chronic oral steroid therapy
- Hospitalization or urgent care visit within 4 weeks of the screening visit
- Near fatal asthma within 2 years of enrollment or high risk of near fatal or fatal asthma 125-127
- Women who are pregnant or lactating
- Parallel MICT and Parallel LASST
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluticasone/salmeterol 250/50 Dry Powder InhalerAlso: Advair DiskusParticipants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization | Drug | LASST Trial Design, MICT Trial Design |
| fluticasone/salmeterol 100/50 Dry Powder InhalerAlso: Advair DiskusParticipants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization | Drug | LASST Trial Design, MICT Trial Design |
| fluticasone 100mcg Dry Powder InhalerAlso: Flovent DiskusParticipants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization | Drug | LASST Trial Design, MICT Trial Design |
Primary outcome
Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8)
Time frame: Screening (Visit 1, week -8)
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.
Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8)
Time frame: Screening (Visit 1, week -8)
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.
11 secondary outcomes
Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12)
Time frame: Final Visit (Visit 6, Week12)
Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12)
Time frame: Final Visit (Visit 6, Week12)
Asthma Control Test Scores at Screening (Visit 1, Week -8)
Time frame: Screening (Visit 1, week -8)
Asthma Control Test Score at Final Visit (Visit 6, Week12)
Time frame: Final Visit (Visit 6, Week 12)
Spirometry Quality Control Grade
Time frame: Visit 3 (week 0)
Number of Errors in Questionnaires Completed by Participants at Visit 1 (Week -8).
Time frame: Visit 1 (week -8)
Number of Errors in Questionnaires Completed by Participants at Visit 2 (Week -4).
Time frame: Visit 2 (week -4)
Number of Errors in Questionnaires Completed by Participants at Visit 3 (Week 0).
Time frame: Visit 3 (week 0)
Number of Errors in Questionnaires Completed by Participants at Visit 4 (Week 3).
Time frame: Visit 4 (week 3)
Number of Errors in Questionnaires Completed by Participants at Visit 5 (Week 6).
Time frame: Visit 5 (week 6)
Number of Errors in Questionnaires Completed by Participants at Visit 6 (Week 12).
Time frame: Visit 6 (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25847579Blake K, Holbrook JT, Antal H, Shade D, Bunnell HT, McCahan SM, Wise RA, Pennington C, Garfinkel P, Wysocki T. Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale. Contemp Clin Trials. 2015 May;42:105-18. doi: 10.1016/j.cct.2015.03.012. Epub 2015 Apr 3.
- Background: PubMed 28109951Antal H, Bunnell HT, McCahan SM, Pennington C, Wysocki T, Blake KV. A cognitive approach for design of a multimedia informed consent video and website in pediatric research. J Biomed Inform. 2017 Feb;66:248-258. doi: 10.1016/j.jbi.2017.01.011. Epub 2017 Jan 19.
- Derived from this study: PubMed 37347518Blake KV, Antal H, Bunnell HT, He J, Henderson R, Holbrook JT, McCahan SM, Pennington C, Rogers L, Shade D, Sugar EA, Taylor A, Wise RA, Wysocki T. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial. JMIR Pediatr Parent. 2023 Jun 22;6:e44252. doi: 10.2196/44252.
- Individual participant dataSharing planned: Yes. Deidentified datasets, study forms, study protocol, study manual of procedures will be deposited into BioLINCC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Blake, PharmD principal investigator
Nemours Children's Clinic Jacksonville FL
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fluticasone/salmeterol 250/50 Dry Powder Inhaler, fluticasone/salmeterol 100/50 Dry Powder Inhaler and fluticasone 100mcg Dry Powder Inhaler in people with Asthma, run by Nemours Children's Clinic at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8) (time frame: Screening (Visit 1, week -8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061280, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.