Clinical trial NCT01586468 (phase 2, status: completed)
Conditions: allergic rhinitis
ICD codes: J30.89, J30.9, J30.2, J30.1, J30.5, J30.81
Drugs: wf10, nacl solution
SMILES: O.O=O.[O-][Cl]=O.[O-][Cl]=O.[O-][Cl]=O.[O-][Cl]=O
Eligibility 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)

          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 70 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:

               1. 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

               2. 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.

        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 medium or high daily dose inhaled glucocorticosteroids (as
             described in GINA guidelines - see App. III)) 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 (see section 10.1.5 for a complete list of prohibited medications).

          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.