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Corticosteroid

ICS/LABA for Asthma Nonadherence

Phase 1 & 2
Recruiting
Led By James Krings, MD MSc
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 but less than or equal to 20 indicating partially controlled or moderately uncontrolled asthma.
Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

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.

Who is the study for?
This trial is for people aged 18-75 with mild or moderate persistent asthma who have been non-adherent to their daily maintenance inhalers, missing at least two expected refills in the past six months. Participants must have partially controlled or moderately uncontrolled asthma and be willing to use a smartphone-connected device.Check my eligibility
What is being tested?
The study tests if using budesonide/formoterol only when symptoms occur is as effective as sticking to regular maintenance inhaler therapy combined with symptom-driven SABA. It aims to address the issue of patients not regularly using their prescribed inhalers.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with inhaled steroids and bronchodilators such as throat irritation, coughing, hoarseness, dry mouth, headache, tremors, nervousness, and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My asthma is partially controlled, with an ACT score between 12 and 20.
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I have been diagnosed with persistent asthma and have been on a prescribed asthma treatment plan for at least 6 months.
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I am between 18 and 75 years old.
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I understand the study and agree to participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to inhaler strategy delineated using an electronic inhaler sensor
Secondary outcome measures
Adverse and serious adverse events
Change in Asthma Control Questionnaire (ACQ)
Change in Asthma Quality of Life Questionnaire (AQLQ)
+8 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: As needed inhaled corticosteroid and long-acting beta-agonistActive Control1 Intervention
Symptom-driven ICS/LABA treatment strategy
Group II: Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonistPlacebo Group1 Intervention
Continue maintenance ICS and SABA therapy

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,924 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,683 Previous Clinical Trials
6,930,818 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
319 Previous Clinical Trials
391,691 Total Patients Enrolled

Media Library

Budesonide/Formoterol (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05689983 — Phase 1 & 2
Medication Nonadherence Research Study Groups: As needed inhaled corticosteroid and long-acting beta-agonist, Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist
Medication Nonadherence Clinical Trial 2023: Budesonide/Formoterol Highlights & Side Effects. Trial Name: NCT05689983 — Phase 1 & 2
Budesonide/Formoterol (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05689983 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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

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

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~14 spots leftby Mar 2025