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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
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 moreAwards & 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
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
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National Institutes of Health (NIH)NIH
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National Center for Advancing Translational Sciences (NCATS)NIH
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412,828 Total Patients Enrolled
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413 Patients Enrolled for Asthma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain lung diseases like chronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1 anti-trypsin deficiency.You are between 12 and 75 years old when you join the study.You have been diagnosed with mild or moderate persistent asthma and have been using certain medications for at least 6 months.You have been in the intensive care unit for asthma in the past year.You haven't been taking your prescribed asthma medication as directed, such as missing refills or having a low score on a medication adherence test.If you are between 12 and 17 years old and your asthma is partially controlled or moderately uncontrolled, you may be eligible to participate.
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