Persistent Allergic Rhinitis. MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Product Name: WF10
Product Code: OXO-K993
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: OXO-K993
Other descriptive name: Stabilized Chlorite Solution
Concentration u
Sponsors
Nuvo Research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) History of persistent allergic rhinitis for at least 2 years prior to enrolment. Concurrent history of asthma is permitted. 2.) Positive allergen skin test to the relevant allergen(s), performed within the previous 2 years prior to enrolment. 3.) Mean score =6 for the baseline Total Nasal Symptom Score (TNSS) (see section 10.2.3.1.1 (a) for definition of baseline TNSS). 4.) Screening laboratory values within normal range, except those related to the primary disease, including eosinophil count, and elevated glucose is allowed. 5.) Age between 18 and 65 years, inclusive. 6.) The subject must be able to read and understand German well enough to answer the questions in the TNSS and Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ), without any translation or explanation. 7.)If female, the subject: a) Cannot become pregnant because she is surgically sterile (hysterectomy or tubal ligation), or is postmenopausal for at least 6 months prior to the screening visit. OR b) Is not pregnant, with a negative pregnancy test at screening (confirmed at the baseline visit), and uses an acceptable method of contraception with a low failure rate (PEARL Index) (i.e. less than 1% per year) when used consistently and correct (including oral contraceptives, hormone implant, intrauterine device, male sexual partner(s) surgically sterile, abstinence). 8.) Except for persistent allergic rhinitis, the subject is in reasonably good health, as determined by the discretion of the study investigator (based on the physical examination and electrocardiogram [ECG] results). 9.) The subject has signed an informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.) Non-allergic rhinitis, rhinitis medicamentosa, idiopathic rhinitis or sinusitis. 2.) History of nasal surgery in the 6 months prior to enrolment. 3.) An upper respiratory or sinus infection within the 2 weeks prior to enrolment. 4.) Presence of a severely deviated septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction. 5.) Use of intramuscular glucocorticosteroids in the 12 weeks prior to enrolment; use of oral, intravenous or inhaled glucocorticosteroids in the 4 weeks prior to enrolment; use of topical (nasal or ocular) glucocorticosteroids in the 2 weeks prior to enrolment. 6.) Use of anti-IgE antibodies (e.g. omalizumab) in the 12 weeks prior to enrolment. 7.) Use of anti-leukotrienes (e.g. montelukast) in the 4 weeks prior to enrolment. 8.) Unwillingness to discontinue prohibited medications and avoid their use during the study. 9.) Severe haematopoetic, cardiovascular, hepatic, renal, neurological or psychiatric disease. 10.) Glucose-6-phosphate dehydrogenase deficiency (activity < 60% = < WHO class 4) 11.) A female subject who is lactating. 12.) Planned travel outside of the study area during the first 22 days of the study. 13.) Any infirmity, disability or geographical location that would limit compliance with the protocol. 14.) A subject who has previously been randomized into this study, received at least one dose of study treatment and been withdrawn from this trial will not be allowed to re-enter. 15.) Use of another investigational drug within the 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of WF10 infusions in the treatment of subjects with persistent allergic rhinitis. The primary efficacy variable will be the reflective TNSS. The primary efficacy analysis will be the change from baseline to final of the TNSS. Baseline TNSS is calculated as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit T1 plus the morning pre-dose TNSS on Day 1 (total of 7 assessments). The final TNSS is defined as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit F3 plus the morning TNSS on Visit F3 (total of 7 assessments);Secondary Objective: Secondary efficacy analyses will include comparison of the change from Visit T1 to Visit F3 of the visit day mean TNSS score (i.e., night before and morning of visit day), morning TNSS score, evening TNSS score, MiniRQLQ score, POHA score, and rhinometric and spirometric parameters.;Primary end point(s): The conclusion of efficacy for the study intervention will be based on the primary efficacy analysis in the PP population data set. The primary efficacy analysis will be the comparison between treatment groups in the change from baseline (Visit T1) to Visit F3 of the TNSS. Baseline TNSS is calculated as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit T1 plus the morning pre-dose TNSS on Day 1 (total of 7 assessments). The final TNSS is calculated as the mean of the morning and evening TNSS assessments for the 3 days prior to Visit F3 plus the morning TNSS at Visit F3 (total of 7 assessments). | — |
Countries
Germany
Outcome results
None listed