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Corticosteroid and Long-Acting Beta Agonist Combination

ICS/LABA Therapy for Asthma Non-adherence

Phase 1 & 2
Recruiting
Led By James G 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve adherence to maintenance inhalers in asthmatic patients, which could help reduce hospitalizations due to asthma.

Who is the study for?
This trial is for people aged 12-75 with mild or moderate persistent asthma who have been prescribed maintenance inhalers and as-needed SABA but are not using their inhalers regularly. They must own a smartphone, have missed at least two ICS refills in the past six months, and have partially controlled to moderately uncontrolled asthma.
What is being tested?
The study compares adherence to budesonide/formoterol taken only when symptoms occur versus regular use of maintenance ICS plus symptom-driven SABA. It aims to address the issue of patients not sticking to daily inhaler routines by testing a new method that matches medication intake with symptom occurrence.
What are the potential side effects?
Possible side effects include those commonly associated with inhaled corticosteroids (ICS) and long-acting beta agonists (LABA), such as throat irritation, hoarseness, coughing, headaches, and increased risk of infections like pneumonia.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
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-agonistActive Control1 Intervention
Continue maintenance ICS and SABA therapy

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,989 Previous Clinical Trials
2,295,758 Total Patients Enrolled
16 Trials studying Asthma
2,987 Patients Enrolled for Asthma
National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,178 Total Patients Enrolled
59 Trials studying Asthma
8,596 Patients Enrolled for Asthma
National Center for Advancing Translational Sciences (NCATS)NIH
362 Previous Clinical Trials
412,404 Total Patients Enrolled
5 Trials studying Asthma
413 Patients Enrolled for Asthma

Media Library

Budesonide/Formoterol (Corticosteroid and Long-Acting Beta Agonist Combination) Clinical Trial Eligibility Overview. Trial Name: NCT05111262 — Phase 1 & 2
~3 spots leftby Jan 2025
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