As needed inhaled corticosteroid and long-acting beta-agonist for Medication Nonadherence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University in St. Louis School of Medicine, Saint Louis, MOMedication Nonadherence+1 MoreAdherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA - Drug
Eligibility
12 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial seeks to assess why people don't take their inhalers & test a new approach to reduce asthma hospitalization due to non-adherence.

Eligible Conditions
  • Childhood Asthma
  • Medication Nonadherence

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Glycine Buffer
1
TASC Intervention
2
Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 24 weeks

24 weeks
Adherence to inhaler strategy delineated using an electronic inhaler sensor
Adverse and serious adverse events
Change in Asthma Control Questionnaire (ACQ)
Change in Asthma Quality of Life Questionnaire (AQLQ)
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ)
Change in asthma control test (ACT)
ICS exposure
Number of asthma exacerbations
Time to asthma exacerbation

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Glycine Buffer
2
TASC Intervention
3
Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg

Trial Design

2 Treatment Groups

As needed inhaled corticosteroid and long-acting beta-agonist
1 of 2
Standard therapy: maintenance inhaled corticosteroid and as needed short-acting ...
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: As needed inhaled corticosteroid and long-acting beta-agonist · Has Placebo Group · Phase 1 & 2

As needed inhaled corticosteroid and long-acting beta-agonist
Drug
ActiveComparator Group · 1 Intervention: Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA · Intervention Types: Drug
Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist
Drug
PlaceboComparator Group · 1 Intervention: Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,822 Previous Clinical Trials
2,284,070 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,471 Previous Clinical Trials
24,591,508 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
198 Previous Clinical Trials
355,904 Total Patients Enrolled
James Krings, MD MScPrincipal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 12 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an iPhone or Android smartphone with an internet connection and are willing to use the Adherium device.
References

Frequently Asked Questions

Is the upper age limit for this experiment beyond eighty-five years old?

"The target demographic for this research is children aged 12-17." - Anonymous Online Contributor

Unverified Answer

What type of participants would be best suited to enroll in this medical study?

"The eligibility criteria for this clinical trial is composed of participants aged 12 to 17 with a history of medication nonadherence. The research team hopes to recruit approximately 40 individuals that meet these requirements." - Anonymous Online Contributor

Unverified Answer

What is the projected enrollment size of this research initiative?

"Affirmative. According to clinicaltrials.gov, this medical trial was posted on April 1st 2022 and is open for enrollment as of January 9th 2023. The study aims to recruit 40 patients from one specific site location." - Anonymous Online Contributor

Unverified Answer

Is there any availability for applicants to join this clinical trial?

"Clinicaltrials.gov reveals that this study is actively seeking participants; it was first uploaded to the website on April 1st 2022, and its details were most recently modified on January 9th 2023." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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