Moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to olive pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline
Conditions
Brief summary
The primary (efficacy) endpoint is defined as the absolute difference in mean CSMS (Combined Symptom and Medication Score) during Peak Olive Pollen Period (POPP) of each active treatment group compared to the placebo treatment group.
Detailed description
Absolute and relative differences in mean CSMS during OPS between active and placebo treatment groups., Absolute and relative differences in mean dSS during POPP and OPS., Absolute and relative differences in mean dMS during POPP and OPS., Global Rhinoconjunctivitis Discomfort with a Visual Analogue Scale (VAS)., Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing basal and post-treatment scoring., Well and severe days: A well day is defined as a day without administration of any rescue medication (dMS = 0) and with dSS < 0.34 (range 0-3). A severe day is defined (acc. to Pfaar et al. 2014) as a day with a single score = 3 in any of the six symptoms. Percentages of well and severe days will be calculated for each subject as the number of well or severe days in the POPP and OPS in relation to the number of days comprising both periods., Symptom-free days are defined as the days with the absence of symptoms (dSS = 0) and without administration of any rescue medication (dMS = 0), expressed as percentage of days during the POPP and OPS, tNPT titrated Nasal Provocation Test: To assess the efficacy of each dose of CLU-RX-OLE compared to placebo. Defined as the percentage of patients with an increased dosing step and the change in the number of dosing steps needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the four study groups, To analyse the safety and tolerability of each dose of CLU-RX-OLE compared to placebo by Treatment-Emergent Adverse Drug Reactions (TEADR) and patients affected with TEADRs in each group.
Interventions
DRUGMometasona cinfa 50 microgramos/pulverización Suspensión para pulverización nasal
DRUGCLU-RX-OLE high dose
DRUGsmell
DRUGProvokations-Testlösung Esche 5.000 BE/ml Lyophilisat und Lösungsmittel
DRUGMometasona furoato Kern Pharma 50 microgramos suspensión para pulverización nasal
DRUGLoratadina Kern Pharma 10 mg comprimidos EFG
DRUGHund Prick Test RX 20 µg/ml Pricktestlösung
DRUGAlternaria alternata Prick Test RX
3 µg/ml Pricktestlösung
DRUGloratadina cinfa 10 mg comprimidos EFG
DRUGRagweed Prick Test RX 500 µg/ml Pricktestlösung
DRUGCLU-RX-OLE low dose
DRUGCLU-RX-OLE mid dose
DRUGOlivenbaum Prick Test RX 50 HEP/ml Pricktestlösung
DRUGPrednisona KERN PHARMA 10 mg comprimidos
Sponsors
ROXALL Medizin GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary (efficacy) endpoint is defined as the absolute difference in mean CSMS (Combined Symptom and Medication Score) during Peak Olive Pollen Period (POPP) of each active treatment group compared to the placebo treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute and relative differences in mean CSMS during OPS between active and placebo treatment groups., Absolute and relative differences in mean dSS during POPP and OPS., Absolute and relative differences in mean dMS during POPP and OPS., Global Rhinoconjunctivitis Discomfort with a Visual Analogue Scale (VAS)., Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing basal and post-treatment scoring., Well and severe days: A well day is defined as a day without administration of any rescue medication (dMS = 0) and with dSS < 0.34 (range 0-3). A severe day is defined (acc. to Pfaar et al. 2014) as a day with a single score = 3 in any of the six symptoms. Percentages of well and severe days will be calculated for each subject as the number of well or severe days in the POPP and OPS in relation to the number of days comprising both periods., Symptom-free days are defined as the days with the absence of symptoms (dSS = 0) an | — |
Countries
Spain
Outcome results
None listed