Nonsteroidal anti-inflammatory drug Exacerbated Respiratory Disease (N-ERD)
Conditions
Brief summary
Change from baseline in VAS for rhinosinusitis and asthma severity, Change from baseline in NC score, Change from baseline in ACQ-6 score, Change from baseline in SNOT-22 score, Change from baseline in AQLQ(S), Change from baseline in PGIC, Change from baseline in sQODNS score, Change from baseline in EQ-5D-5L, Change from baseline in provoking dose, Proportion of patients with serious and non-serious adverse events related to gastro-intestinal disturbance (nausea, vomiting, diarrhoea, abdominal pain)
Detailed description
Change from baseline in PNIF, Change from baseline in smell score (UPSIT), Change from baseline in FEV1, Change from baseline in FeNO and nNO, Change from baseline in NPS, Proportion of patients who have or are planned for surgery of nasal polyps, as well as time-to-event, Proportion of patients with OCS use for chronic rhinosinusitis/asthma exacerbation, as well as time to first course, number of courses, total dose used, total duration, Dosage (dose and frequency) of inhaled/intranasal corticosteroids, reported as dosage during desensitisation and dosage during maintenance therapy (after goal of escalation is reached)
Interventions
Sponsors
UZ Leuven, UZ Leuven
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in VAS for rhinosinusitis and asthma severity, Change from baseline in NC score, Change from baseline in ACQ-6 score, Change from baseline in SNOT-22 score, Change from baseline in AQLQ(S), Change from baseline in PGIC, Change from baseline in sQODNS score, Change from baseline in EQ-5D-5L, Change from baseline in provoking dose, Proportion of patients with serious and non-serious adverse events related to gastro-intestinal disturbance (nausea, vomiting, diarrhoea, abdominal pain) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in PNIF, Change from baseline in smell score (UPSIT), Change from baseline in FEV1, Change from baseline in FeNO and nNO, Change from baseline in NPS, Proportion of patients who have or are planned for surgery of nasal polyps, as well as time-to-event, Proportion of patients with OCS use for chronic rhinosinusitis/asthma exacerbation, as well as time to first course, number of courses, total dose used, total duration, Dosage (dose and frequency) of inhaled/intranasal corticosteroids, reported as dosage during desensitisation and dosage during maintenance therapy (after goal of escalation is reached) | — |
Countries
Belgium
Outcome results
None listed