chronic rhinosinusitis with nasal polyps (CRSwNP)
Conditions
Brief summary
In "controlled" patients presence of 0 & in "partly controlled" patients max. 2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment
Detailed description
1) changes in SNOT-22, ACQ and smell test scores from baseline to 52 weeks; 2) changes in disease control assessments from baseline to 52 weeks by given drug; and 3) baseline and demographic data such as: age, sex, comorbidities, BMI, level of education, duration of biologic treatment.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In "controlled" patients presence of 0 & in "partly controlled" patients max. 2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) changes in SNOT-22, ACQ and smell test scores from baseline to 52 weeks; 2) changes in disease control assessments from baseline to 52 weeks by given drug; and 3) baseline and demographic data such as: age, sex, comorbidities, BMI, level of education, duration of biologic treatment. | — |
Countries
Denmark