Skip to content

Severe Asthma with comorbid BronchiEctasis: response to BIOlogical therapy

Severe Asthma with comorbid BronchiEctasis: response to BIOlogical therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20373
Enrollment
100
Registered
2021-09-11
Start date
2021-10-17
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Severe asthma and bronchiectasis

Interventions

None listed

Sponsors

No
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Dutch adult (>18 yr) included in RAPSODI - Received at least 1 dose of one of the anti-IL-5 treatments (mepolizumab, reslizumab, benralizumab). - Anti- IL-5 treatment was started before 1.9.2020 - Data on presence or absence of BE (reported comorbidity and CT-scan) are available

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

MeasureTime frame
1a. Daily OCS dose Change in daily OCS dose between initiation (= the day of starting anti IL-5) and 1 year after start of anti-IL-5 therapy in OCS dependent patients with severe asthma and comorbid BE. 1b. Exacerbation rate Change in annualized exacerbation rate between 1 year before and 1 year after start of anti-IL-5 therapy in non-OCS dependent patients. Defined as: Percentage of patients with an exacerbation rate 0-1/= 2/>5 exacerbations/yr, 1 year before and 1 year after start of anti-IL-5 therapy. 2. Cumulative OCS dose Change in cumulative OCS use between 1 year before and 1 year after start of anti-IL-5 therapy in all patients with SEA and BE will be calculated as the sum of the amount of issued tablets multiplied by the strength (mg per tablet) in months -12 to 0 and months 0 to 12.

Secondary

MeasureTime frame
Patient reported outcome measures (PROMs) - 6-item Asthma Control Questionnaire score (ACQ-6) (22) - Asthma Quality of life questionnaire (AQLQ) (23) Asthma-related health care use

Contacts

Public ContactSaar Van Nederveen-Bendien

HAGA Ziekenhuis

s.vannederveen@hagaziekenhuis.nl0031639592319

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)