refractory allergic rhinitis MedDRA version: 17.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855
Conditions
Interventions
Product Name: WF10
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXO-K993
CAS Number: 92047-76-2
Other descriptive name: TCDO
Concentration unit: mmol/l millimole(s)/
Sponsors
Nuvo Research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following conditions will be eligible for enrollment: IN.1) Male and female outpatients (in female patients, see also item FEM.1-3 below) IN.2) 18-70 years of age IN.3) Body weight 45 – 110 kg (included) IN.4) History of refractory rhinitis defined as persistence or recurrence of symptomatic episodes in spite of conventional treatment over the last one year before the screening (SCR) visit IN.5) Positive allergen skin test to the relevant allergen(s) within the last two years before SCR IN.6) Total nasal symptom score TNSS (see Section 6.1.1) = 6 (/12) (at the baseline visit [BL]) IN.7) ± controlled bronchial asthma provided it is stable and is not treated with more than low-to-medium dose inhaled corticosteroids IN.8) Ability to read and understand German well enough to answer the scoring questions (TNSS, TOSS) and the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) without translation or explanation IN.9) Willing and able to provide informed consent In order to be eligible, female patients also need to comply with all of the following criteria: FEM.1) Non-pregnant FEM.2) Non-lactating FEM.3) Non-childbearing potential, while o Surgically sterile o OR post-menopausal for at least 6 months prior to the screening (SCR) visit o OR having a negative pregnancy test at SCR and using a method of contraception with a low failure rate (PEARL Index) (i.e. less than 1% per year) when used consistently and correctly (including oral contraceptives, hormone implant, intrauterine device, male sexual partner(s) surgically sterile, abstinence) 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 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from enrollment: EX.2) Previous participation in the trial EX.3) Participant in any other trial during the last 30 days EX.4) Previous treatment with WF10 within the last two years EX.5) Non-allergic rhinitis, rhinitis medicamentosa, idiopathic rhinitis or sinusitis; nasal surgery within the last 6 months before SCR; presence of a severely deviated septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction EX.6) Uncontrolled bronchial asthma EX.7) Any co-morbidity (or sign thereof) which might put the patient at undue risk or might confound the evaluation of the trial criteria (as based on the Investigator's evaluation of the screening data incl. ECG) in particular, but not limited to: relevant haematological, cardiovascular, hepatic, renal, neurological or psychiatric disease EX.8) Clinical laboratory tests outside of the normal range to an extent that is to be considered clinically relevant including, but not limited to: liver enzymes > 3 times the upper limit of the normal range; haemoglobin lower than 110% of the lower limit of the gender specific normal laboratory range EX.9) Glucose-6-phosphate dehydrogenase (G6PD) deficiency = class III i.e. = 60% activity EX.10) Sickle-cell anaemia EX.11) Present or recent treatment with prohibited medication (see Section 5.9) EX.12) Patients with a completed series of anti-allergy immunotherapy concluded within the past year or who are still receiving such therapy EX.13) Patients with unsuitable veins EX.14) Planned travel outside the study region during the first month of the trial EX.15) Patients unwilling or unable to keep the diary (as evaluated at BL) EX.16) Patients with a baseline use (between SCR- and BL-visit) of rescue medication that is to be considered exaggerated and/or that reflects inadequate handling of the rescue medication (as evaluated at BL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe and compare the efficacy, safety and tolerability of treatment with WF10 and its main constituents NRI-1025 ("chlorite") and NRI-1026 ("chlorate") relative to saline in patients with refractory allergic rhinitis. ;Secondary Objective: To compare the efficacy, safety and tolerability of treatment with NRI-1025 and/or NRI-1026 with that of WF10. ;Primary end point(s): Total nasal symptom score (TNSS);Timepoint(s) of evaluation of this end point: Third week after the start of a five-day treatment cycle of daily infusions of the IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Total ocular symptom score (TOSS) - Composite TNOSS (= TNSS + TOSS) - Single symptoms of TNSS and TOSS - Use of rescue medication (desloratidine 5 mg tablets as provided) - MiniRQLQ - Patients' overall evaluation of efficacy - Investigators' overall evaluation of efficacy Safety and tolerability: - wellbeing and adverse events - physical examination (and on-study changes thereof) - clinical laboratory safety tests (haematology, clinical chemistry, urinalysis) - vital function - 12-lead ECG - Spirometry - Patients' overall evaluation of tolerability - Investigators' overall evaluation of tolerability Optional criteria (at selected sites only): - At selected sites: whole-body-plethysmography - At selected sites: exhaled NO (eNO) ;Timepoint(s) of evaluation of this end point: Safety and tolerability to be evaluated on the infusion days and three, six, nine, twelve, and sixteen weeks after the start of the five-day medication cycle. Secondary efficacy criteria to be evaluated three, six, nine, twelve, and sixteen weeks after the start of the five-day medication cycle. | — |
Countries
Germany
Contacts
Public ContactTrial coordinator
ACPS - Network GmbH
Outcome results
None listed