Investigation of the effects of novel medication and its constituents in patients with allergic rhinitis that is not responsive to conventional medicatio

Phase 1

• Conditions: refractory allergic rhinitis; MedDRA version: 17.0Level: LLTClassification code 10001723Term: Allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-003096-35-DE
• Lead Sponsor: uvo Research GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-16
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>;Secondary Objective: To compare the efficacy, safety and tolerability of treatment with NRI-1025 and/or NRI-1026 with that of WF10.<br>;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