AsthmaRIDUNANCT01449409
Reduce IDentified UNcontrolled Asthma
A study testing Real-time asthma care outreach in people with Asthma, run by Kaiser Permanente at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 56 years
- Conditions the study is for
- Asthma
- What is being tested?
- Real-time asthma care outreach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2011to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 56 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- KPSC members at time of uncontrolled event:
- 12-56 years of age
- Continuously enrolled and with pharmacy benefit for the past year
- Dispensed inhaled corticosteroid (ICS) in the past 6 months.
- Uncontrolled asthma: defined within the past year
- 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.
Who cannot join
- Patients with chronic obstructive lung disease,
- emphysema,
- cystic fibrosis,
- chronic bronchitis,
- bronchiectasis,
- Churg Strauss,
Show all 15Show fewer
- Wegener's,
- sarcoidosis,
- pulmonary hypertension or other clinically relevant non-asthma pulmonary disorder such as autoimmunity,
- immune deficiency,
- cancer,
- HIV,
- steroid dependent asthma,
- omalizumab therapy within the past 3 months, and
- requirement for an interpreter.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California Region
San Diego, California, 92111
About this study
Official title: Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)
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.
Read the detailed description
Co-primary Objectives: Determine the effectiveness of real-time identification administratively of uncontrolled asthma and real-time outreach administratively to optimize National asthma care guideline implementation compared to standard KP asthma outreach to improve asthma control (subsequent asthma impairment and risk, separately).
Hypothesis 1: Real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard Kaiser Permanente (KP) asthma outreach will reduce subsequent asthma impairment and risk, separately.
Hypothesis 2: Real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will increase the proportion of patients who receive step-up care for impairment and risk.
Hypothesis 3: The real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will lead to increased step-up care that will reduce subsequent asthma impairment and risk.
Hypothesis 4: Specific demographic characteristics (older age, female gender, non-Hispanic white ethnicity, higher census block education/income level) will be associated with a differential response in the intervention group.
Study Objectives:
- Determine whether real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will reduce subsequent asthma impairment and risk, separately.
2: Determine whether real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will increase the proportion of patients who receive step-up care for impairment and risk.
3: Determine whether the real-time notification of uncontrolled asthma status to asthma specialists and patients will lead to increased step-up care that will reduce subsequent asthma impairment and risk compared to standard KP asthma outreach.
4: Determine whether there exist specific demographic characteristics (older age, female gender, non-Hispanic white ethnicity, higher census block education/income level) that are associated with a greater differential efficacy in the intervention group.
- Determine in an exploratory analysis the frequency, characteristics (demographic, asthma severity, prior health care utilization, etc) and clinical outcomes (impairment and risk) of patients placed on omalizumab step-up therapy.
- Conditions
- Asthma
- Being tested
- Real-time asthma care outreach
- Keywords
- Uncontrolled asthma, Asthma risk, Asthma impairment, Real time asthma outreach program
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time asthma care outreachOther
Also called Expedited asthma care management
Real-time asthma care identification of uncontrolled asthma and real-time notification of patients and their physicians of uncontrolled asthma and directions to improve care. Patients without an asthma specialist visit in the prior 3 years are offered an expedited allergy department referral.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Real-time asthma care outreach | Experimental | Not described Receives: Other: Real-time asthma care outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral corticosteroid courses for asthma exacerbations in risk cohort.
Measure in the follow-up year (1) frequency of patients requiring 2 or more oral corticosteroid courses in cohort with uncontrolled asthma based on risk
Measured: 1 year
Short-acting beta-agonist dispensings.
Frequency of patients requiring 7 or more short-acting beta-agonist dispensings in cohort with uncontrolled asthma based on impairment.
Measured: 1 year
Secondary outcomes (2)
Frequency of patients with documented step-up care.
Measured: 1 year
Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study start1 Feb 2011
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Robert S. Zeiger, MD, PhD, Kaiser Permanente
- Investigators
- Robert S Zeiger, MD, PhD, Principal investigator, Kaiser Permanente Southern California Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449409
- Sponsor's protocol ID
- IRB # 5808
- Acronym
- RIDUNA
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2011
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Zeiger RS, Schatz M, Li Q, Zhang F, Purdum AS, Chen W. Step-up care improves impairment in uncontrolled asthma: an administrative data study. Am J Manag Care. 2010;16(12):897-906.
PubMed 21348560Schatz M, Zeiger RS. Improving asthma outcomes in large populations. J Allergy Clin Immunol. 2011 Aug;128(2):273-7. doi: 10.1016/j.jaci.2011.03.027. Epub 2011 Apr 17.
PubMed 21497885
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)
- ClinicalTrials.gov ID
- NCT01449409
- Acronym / sponsor ID
- RIDUNA / IRB # 5808
- Conditions
- Asthma
- Keywords
- Uncontrolled asthma, Asthma risk, Asthma impairment, Real time asthma outreach program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Co-primary Objectives: Determine the effectiveness of real-time identification administratively of uncontrolled asthma and real-time outreach administratively to optimize National asthma care guideline implementation compared to standard KP asthma outreach to improve asthma control (subsequent asthma impairment and risk, separately).
Hypothesis 1: Real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard Kaiser Permanente (KP) asthma outreach will reduce subsequent asthma impairment and risk, separately.
Hypothesis 2: Real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will increase the proportion of patients who receive step-up care for impairment and risk.
Hypothesis 3: The real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will lead to increased step-up care that will reduce subsequent asthma impairment and risk.
Hypothesis 4: Specific demographic characteristics (older age, female gender, non-Hispanic white ethnicity, higher census block education/income level) will be associated with a differential response in the intervention group.
Study Objectives:
- Determine whether real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will reduce subsequent asthma impairment and risk, separately.
2: Determine whether real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will increase the proportion of patients who receive step-up care for impairment and risk.
3: Determine whether the real-time notification of uncontrolled asthma status to asthma specialists and patients will lead to increased step-up care that will reduce subsequent asthma impairment and risk compared to standard KP asthma outreach.
4: Determine whether there exist specific demographic characteristics (older age, female gender, non-Hispanic white ethnicity, higher census block education/income level) that are associated with a greater differential efficacy in the intervention group.
- Determine in an exploratory analysis the frequency, characteristics (demographic, asthma severity, prior health care utilization, etc) and clinical outcomes (impairment and risk) of patients placed on omalizumab step-up therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Real-time asthma care outreach | Experimental | Other: Real-time asthma care outreach |
Who may qualify
- Ages
- 12 to 56 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 12-56 years of age
- Continuously enrolled and with pharmacy benefit for the past year
- Dispensed inhaled corticosteroid (ICS) in the past 6 months.
- Uncontrolled asthma: defined within the past year
Key exclusion criteria (15 listed)
- Patients with chronic obstructive lung disease,
- emphysema,
- cystic fibrosis,
- chronic bronchitis,
- bronchiectasis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time asthma care outreachAlso: Expedited asthma care managementReal-time asthma care identification of uncontrolled asthma and real-time notification of patients and their physicians of uncontrolled asthma and directions to improve care. Patients without an asthma specialist visit in the prior 3 years are offered an expedited allergy department referral. | Other | Real-time asthma care outreach |
Primary outcome
Oral corticosteroid courses for asthma exacerbations in risk cohort.
Time frame: 1 year
Measure in the follow-up year (1) frequency of patients requiring 2 or more oral corticosteroid courses in cohort with uncontrolled asthma based on risk
Short-acting beta-agonist dispensings.
Time frame: 1 year
Frequency of patients requiring 7 or more short-acting beta-agonist dispensings in cohort with uncontrolled asthma based on impairment.
2 secondary outcomes
Frequency of patients with documented step-up care.
Time frame: 1 year
Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 21348560Zeiger RS, Schatz M, Li Q, Zhang F, Purdum AS, Chen W. Step-up care improves impairment in uncontrolled asthma: an administrative data study. Am J Manag Care. 2010;16(12):897-906.
- Background: PubMed 21497885Schatz M, Zeiger RS. Improving asthma outcomes in large populations. J Allergy Clin Immunol. 2011 Aug;128(2):273-7. doi: 10.1016/j.jaci.2011.03.027. Epub 2011 Apr 17.
- Kaiser Permanente Research and Evaluation Department Clinical TrialsLink provided by the sponsor.
- Kaiser Permanente Health ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Zeiger, MD, PhD principal investigator
Kaiser Permanente Southern California Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time asthma care outreach in people with Asthma, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral corticosteroid courses for asthma exacerbations in risk cohort. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01449409, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.