Pharmacokinetics and immunological aspects in nasal polyp patients treated with biologics: a pilot study

Pharmacokinetics and immunological aspects in nasal polyp patients treated with biologics: a pilot study - Biologics in nasal polyp patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51449

Enrollment

Registered

2022-04-21

Start date

2022-06-06

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

chronic rhinosinusitis with nasal polyps

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 years or above - eligible for treatment with biologics: criteria include: * previous extensive surgery * AND at least 3 out of 5 of the following items: * SNOT22 score above 39 * anosmia * a chronic need for oral steroids * the use of inhalation corticosteroids * signs of eosinophily (blood eosinophils >= 0.25x10^9 / L or >=10 eosinophils per high-power field in histology)

Exclusion criteria

Exclusion criteria: - Age

Design outcomes

Primary

Measure	Time frame
To investigate the dose - response relationship and therapeutic window of biologics in the treatment of CRSwNP. Response refers to clinical outcome, as measured by the SNOT22 questionnaire.	—

Secondary

Measure	Time frame
1. To investigate the effect of biologics on the sensibilisation pattern of specific IgE and its relationship with (clinical) treatment outcome. 2. To investigate the effect of biologics on type 2 T helper and regulatory T cells, and its relationship with (clinical) treatment outcome.	—

Countries

Netherlands

Outcome results