Real-Time Care Outreach for Asthma

(RIDUNA Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must be taking: Inhaled corticosteroids

Must not be taking: Omalizumab

Disqualifiers: COPD, Emphysema, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of real-time identification of uncontrolled asthma by electronic administrative records linked to real-time notification of uncontrolled status to patients and asthma specialists with recommended guideline directed intervention by physicians. The investigators hypothesize that real-time outreach following National guideline asthma care recommendations, after real-time identification of an uncontrolled asthma event in persistent asthmatics on inhaled corticosteroids will lead to better improvements in asthma control (impairment and risk) compared to standard asthma care outreach.

Research Team

Robert S Zeiger, MD, PhD

Principal Investigator

Kaiser Permanente Southern California Region

Eligibility Criteria

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.

Inclusion Criteria

My asthma has been uncontrolled in the past year.

I have used an inhaled corticosteroid in the last 6 months.

I have either used 7 asthma relief inhalers recently or had 2 steroid treatments for asthma attacks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Real-time asthma care outreach

Real-time identification and notification of uncontrolled asthma status to patients and specialists, with guideline-directed intervention

12 months

Follow-up

Participants are monitored for asthma control improvements, including impairment and risk reduction

1 year

Treatment Details

Interventions

• Inhaled Corticosteroids
• Real-time asthma care outreach

Trial Overview 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.

Participant Groups

Group I: Real-time asthma care outreach Experimental Treatment 1 Intervention

Group II: Usual care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD