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NCT02061280 · ClinicalTrials.gov registry record · Phase 4
Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
A Phase 4 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
NCT02061280 is a Phase 4 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 108 participants.
The verdict
NCT02061280, a Phase 4 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
Study 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. 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 comp
Interventions
- DRUG fluticasone/salmeterol 250/50 Dry Powder Inhaler
- DRUG fluticasone/salmeterol 100/50 Dry Powder Inhaler
- DRUG fluticasone 100mcg Dry Powder Inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2013-10 |
| Est. Completion | 2017-02-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02061280
The ClinicalTrials.gov registry entry for NCT02061280 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which fluticasone/salmeterol 250/50 Dry Powder Inhaler is the first listed.
NCT02061280 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02061280 about?
NCT02061280 is a clinical study titled "Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial". 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 t...
What is the current status of trial NCT02061280?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2013-10. Estimated completion is 2017-02-17.
What interventions are being tested in trial NCT02061280?
The interventions under investigation include: fluticasone/salmeterol 250/50 Dry Powder Inhaler (DRUG), fluticasone/salmeterol 100/50 Dry Powder Inhaler (DRUG), fluticasone 100mcg Dry Powder Inhaler (DRUG).
Who is sponsoring clinical trial NCT02061280?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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