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Long-Term Follow-Up In Adult-Onset Asthma

Identifying High-Risk Asthma Patients: Long-Term Follow-Up In Adult-Onset Asthma - Identifying high-risk asthma patients: long-term follow-up in adult-onset asthma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57990
Enrollment
300
Registered
2025-04-14
Start date
2025-10-02
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

Questionnaire Participants will complete one short questionnaires via REDCap (max. 10 minutes) about:Asthma Control Questionnaire (ACQ-6): Assesses asthma control across six items.Health Care Utilizat

Sponsors

Investigator Initiated
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Participation in the original adult-onset asthma cohort study (2009–2012).Consent to be approached for follow-up research (as given in the original study).Able and willing to provide informed consent for this follow-up study.

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:The patient of the initial cohort is not identifiable. The patient does not provide consent to participate in the study.The patient is unable to understand study materials due to cognitive impairment or language barriers (without available translation support).The patient has a diagnosis that contradicts the original asthma diagnosis (e.g., COPD or interstitial lung disease, confirmed after initial inclusion).The patient has an inflammatory comorbidity for which corticosteroids are used, to ensure that all OCS use is related to the treatment of asthma and thus avoid confounding. 

Design outcomes

Primary

MeasureTime frame
OCS exposure during the follow-up period is the main outcome. Patients will be divided in two groups: high exposure is = 1000 mg prednisolone-equivalent, and low exposure is <1000 mg prednisolone-equivalent. The primary outcome of this study is OCS exposure during the follow-up period. Patients will be categorized into two groups based on cumulative OCS use:High OCS exposure: = 1000 mg prednisolone-equivalentLow OCS exposure: < 1000 mg prednisolone-equivalent

Secondary

MeasureTime frame
Secondary questionsDescriptive statistics will be used to describe long-term outcomes of patients with adult onset asthma, including asthma medication use (inhalation corticosteroids (ICS), ß-agonists, long-acting muscarinic antagonists, OCS, and biologics), asthma-control (ACQ-6), lung function, health care utilization (HCU), long-term cumulative OCS exposure (in mg), annual OCS exposure (mg/year), patterns of OCS use over time during the follow-up period, and the number of "bad years" per patient.To explore the association between the use of asthma medication in the last two years and outcomes including OCS exposure, ACQ-6 scores, lung function and health care use, (linear) regression models with adjustment for potential confounders will be used.Predictive models similar to the primary outcome will be constructed predict risk for poor asthma control (high ACQ score), high healthcare utilization (HCU), lower lung function, and the occurrence of bad years. To predict FEV1 decline a (mixed) linear instead of logistic regression model will likely be used. For the number of bad years an appropriate regression model will selected, depending on the distribution of the outcome.To determine how many patients are currently receiving treatment for asthma, what proportion of these are still under hospital-based (secondary care) follow-up, and the proportions on patients in clinical remission, proportions will be given with 95% confidence intervals.

Countries

Netherlands

Contacts

Public ContactM Ploeg

Frisius MC Leeuwarden

michelle.van.der.ploeg@frisiusmc.nl0657572181

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)