Status:
UNKNOWN
AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Allergic Rhinitis
House Dust Mite Allergy
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The combination formul...
Detailed Description
Comparative analysis of the efficacy of intranasal MP29-02 (a novel formulation of azelastine and FP) has already been conducted in patients with moderate-to-severe seasonal AR. The combination formul...
Eligibility Criteria
Inclusion
- Patients with an ARIA-based diagnosis of persistent moderate/severe AR (≥ 2 nasal symptoms suggestive of allergic rhinitis and positive skin prick tests to house dust mite (HDM) (HAL Allergy, Leiden, The Netherlands) at screening. Patients with additional seasonal pollen allergies may be included providing that they are included outside their individual pollen season, and with VAS score for total nasal symptoms of more than 5
- VAS for TNS of more than 5, and rT5SS of more than 8 at both screening and randomization
- Age \> 18 and \< 60 years
- Eosinophilia of more than 5% in nasal secretions at screening
- Nasal hyperreactivity (drop of PNIF \>20 %) at randomization
- Possibility to give reliable information and written informed consent
Exclusion
- Any evidence of clinically relevant acute or chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease at screening
- History of allergic reaction to fluticasone propionate, azelastine hydrochloride or one of the excipients (e.g. benzalkonium chloride, phenylethyl alcohol, microcrystalline cellulose)
- Patients with a change in vision or with a history of increased ocular pressure, glaucoma and/or cataracts
- Patients with tuberculosis, any type of untreated infection, or recent surgical operation or injury to the nose or mouth
- Patients on prolonged use of decongestive nose sprays, suffering from so-called rhinitis medicamentosa
- Patients using other nasal or oral medication affecting nasal function, like nasal corticosteroids, anticholinergics, cromoglycates, leukotriene antagonists, ACE inhibitors during the study or within the last 14 days before randomization; patients using oral corticosteroids during the last 30 days
- Patients using cytochrome P450 inhibitors (e.g. ritonavir)
- Nasal endoscopic evidence of rhinosinusitis with or without nasal polyposis (NP) or structural abnormalities such as clinically relevant septal deviation (septum reaching concha inferior or lateral nasal wall) or septal perforation at screening
- Patients on immunotherapy (IT) for HDM or with history of IT for HDM
- Patients with a psychiatric, addictive, or any disorder of which the investigators feel that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire
- Patients being enrolled in other clinical trials within the last 3 months
- Pregnancy or breastfeeding
- Malignancies or severe comorbidity
- Smoking
- Use of anticoagulation medication
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02238353
Start Date
October 1 2014
End Date
December 1 2015
Last Update
December 3 2015
Active Locations (1)
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1
Uz Leuven Dienst Nko
Leuven, Vlaams Brabant, Belgium, 3000