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Corticosteroid
Real-Time Care Outreach for Asthma (RIDUNA Trial)
N/A
Waitlist Available
Led By Robert S Zeiger, MD, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Dispensed inhaled corticosteroid (ICS) in the past 6 months.
Impairment cohort: 7th short-acting beta-agonist (SABA) canister dispensed and/or Risk (exacerbation) cohort: 2nd oral corticosteroid (OCS)dispensing with provider asthma exacerbation encounter within 2 days and at least 1 month after the first OCS dispensing.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether notifying asthma specialists when a patient has an uncontrolled asthma event, and providing recommended interventions, will improve asthma control compared to standard care.
Who is the study for?
The RIDUNA trial is for people aged 12-56 with asthma who've been on inhaled corticosteroids and have uncontrolled symptoms. They should have used a quick-relief inhaler frequently or had repeated need for oral steroids due to severe flare-ups, indicating poor asthma control.
What is being tested?
This study tests if notifying both patients and specialists in real-time about uncontrolled asthma events leads to better management compared to usual care. It's based on following national guidelines right after identifying these events through electronic records.
What are the potential side effects?
Since the intervention involves communication and potential changes in treatment rather than new medications, there are no direct side effects from the trial itself. However, adjustments in medication may carry their own risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have used an inhaled corticosteroid in the last 6 months.
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I have either used 7 asthma relief inhalers recently or had 2 steroid treatments for asthma attacks.
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I am between 12 and 56 years old.
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I have had continuous health insurance with pharmacy benefits for the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Oral corticosteroid courses for asthma exacerbations in risk cohort.
Short-acting beta-agonist dispensings.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Real-time asthma care outreachExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
566,436 Total Patients Enrolled
50 Trials studying Asthma
18,512 Patients Enrolled for Asthma
Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,728,622 Total Patients Enrolled
8 Trials studying Asthma
50,052 Patients Enrolled for Asthma
Robert S Zeiger, MD, PhDPrincipal InvestigatorKaiser Permanente Southern California Region
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