AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)

Inclusion Criteria:

1. Patients with an ARIA-based diagnosis of persistent moderate/severe AR (≥ 2 nasalsymptoms suggestive of allergic rhinitis and positive skin prick tests to house dustmite (HDM) (HAL Allergy, Leiden, The Netherlands) at screening. Patients withadditional seasonal pollen allergies may be included providing that they are includedoutside their individual pollen season, and with VAS score for total nasal symptoms ofmore than 5

2. VAS for TNS of more than 5, and rT5SS of more than 8 at both screening andrandomization

3. Age > 18 and < 60 years

4. Eosinophilia of more than 5% in nasal secretions at screening

5. Nasal hyperreactivity (drop of PNIF >20 %) at randomization

6. Possibility to give reliable information and written informed consent

Exclusion Criteria:

1. Any evidence of clinically relevant acute or chronic cardiovascular, pulmonary,hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental,neurological, or other disease at screening

2. History of allergic reaction to fluticasone propionate, azelastine hydrochloride orone of the excipients (e.g. benzalkonium chloride, phenylethyl alcohol,microcrystalline cellulose)

3. Patients with a change in vision or with a history of increased ocular pressure,glaucoma and/or cataracts

4. Patients with tuberculosis, any type of untreated infection, or recent surgicaloperation or injury to the nose or mouth

5. Patients on prolonged use of decongestive nose sprays, suffering from so-calledrhinitis medicamentosa

6. Patients using other nasal or oral medication affecting nasal function, like nasalcorticosteroids, anticholinergics, cromoglycates, leukotriene antagonists, ACEinhibitors during the study or within the last 14 days before randomization; patientsusing oral corticosteroids during the last 30 days

7. Patients using cytochrome P450 inhibitors (e.g. ritonavir)

8. Nasal endoscopic evidence of rhinosinusitis with or without nasal polyposis (NP) orstructural abnormalities such as clinically relevant septal deviation (septum reachingconcha inferior or lateral nasal wall) or septal perforation at screening

9. Patients on immunotherapy (IT) for HDM or with history of IT for HDM

10. Patients with a psychiatric, addictive, or any disorder of which the investigatorsfeel that this may compromise the ability to give truly informed consent forparticipation in this study or provide reliable information on the questionnaire

11. Patients being enrolled in other clinical trials within the last 3 months

12. Pregnancy or breastfeeding

13. Malignancies or severe comorbidity

14. Smoking

15. Use of anticoagulation medication