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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.
Age 18-75 at the time of study enrollment.
Must not have
Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.
Current use of a biologic medication or investigational treatment for asthma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

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.
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.
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 am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have completed less than 70% of the required texts after screening.
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I am currently using a biologic or experimental treatment for asthma.
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I was admitted to the ICU for asthma in the past year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to inhaler strategy delineated using an electronic inhaler sensor
Secondary study objectives
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
1,994 Previous Clinical Trials
2,296,103 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,819 Previous Clinical Trials
8,162,376 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
374 Previous Clinical Trials
413,286 Total Patients Enrolled

Media Library

Budesonide/Formoterol (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05689983 — Phase 1 & 2
Medication Nonadherence Research Study Groups: Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist, As needed inhaled corticosteroid and long-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
~0 spots leftby Dec 2024
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