Chronic rhinosinusitis with nasal polyposis
Conditions
Brief summary
Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks, Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks
Detailed description
Change in loss of smell (Proportion with SSIT-16 improved to >8), Improvement in asthma (measured by proportion with ACQ>0.5), Improvement on visual analog scale measuring impact on quality of life of CRSwNP, Tympanometry - proportion with change from B-curve to A or C curve., Expired Nitrous oxide (FeNO) - proportion with less than 25 ppb, Improvement in subjective smell function by visual analog scale, Improvement in aspirin-exacerbated-respiratory-intolerance (AERD) measured by visual analog scale., Improvement in NPS at 52 weeks, Improvement in SNOT-22 at 52 weeks, Proportion meeting the response criteria set by the Danish Medicines council, Proportion of subjects needing rescue treatment (systemic corticosteroids or sinus surgery), Change in Nasal Congestion Score (NCS), Chang in radiologic sinus opacification (Lund-Mackey score), Change in FEV1
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks, Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in loss of smell (Proportion with SSIT-16 improved to >8), Improvement in asthma (measured by proportion with ACQ>0.5), Improvement on visual analog scale measuring impact on quality of life of CRSwNP, Tympanometry - proportion with change from B-curve to A or C curve., Expired Nitrous oxide (FeNO) - proportion with less than 25 ppb, Improvement in subjective smell function by visual analog scale, Improvement in aspirin-exacerbated-respiratory-intolerance (AERD) measured by visual analog scale., Improvement in NPS at 52 weeks, Improvement in SNOT-22 at 52 weeks, Proportion meeting the response criteria set by the Danish Medicines council, Proportion of subjects needing rescue treatment (systemic corticosteroids or sinus surgery), Change in Nasal Congestion Score (NCS), Chang in radiologic sinus opacification (Lund-Mackey score), Change in FEV1 | — |
Countries
Denmark