Clinical trial NCT02238353: AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)
Official title: AZE/FLU Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Allergic Rhinitis
House Dust Mite Allergy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 formulation appeared to be superior in these patients with better symptomatic relief. However, objective analysis of the effect of this treatment on nasal mediators and/or nasal hyperreactivity has not yet been performed and would help in understanding the additional benefit of the combination treatment over monotherapy with nasal corticosteroids.

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 formulation appeared to be superior in these patients with better symptomatic relief. However, objective analysis of the effect of this treatment on nasal mediators and/or nasal hyperreactivity has not yet been performed and would help in understanding the additional benefit of the combination treatment over monotherapy with nasal corticosteroids.

Eligibility criteria: Inclusion Criteria:

1. 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
2. VAS for TNS of more than 5, and rT5SS of more than 8 at both screening and randomization
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 or one 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 surgical operation or injury to the nose or mouth
5. Patients on prolonged use of decongestive nose sprays, suffering from so-called rhinitis medicamentosa
6. 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
7. Patients using cytochrome P450 inhibitors (e.g. ritonavir)
8. 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
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 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
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

Primary outcomes:
measure: change in expression of inflammatory mediators (Histamine / Substance P / IL-5 / EPO)
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: change in PNIF values upon CDA exposure
timeFrame: 4 weeks treatment
Other outcomes:
measure: change in assessment of visual analogue scale (VAS) for total nasal symptom (TNS) and individual nasal symptoms, reflective total of 5 symptom scores (rT5SS) and Allergic Rhinitis Control Test (ARCT)
timeFrame: 1 week after treatment
measure: Effects of therapy with AZE/FP or placebo on nasal inflammatory mediators (Histamine / Substance P (SP) / IL-5 / EPO)
timeFrame: one week after treatment
measure: change in PNIF values upon CDA exposure
timeFrame: 1 week of treatment
measure: change in assessment of visual analogue scale (VAS) for total nasal symptom (TNS) and individual nasal symptoms, rT5SS and Allergic Rhinitis Control Test (ARCT)
timeFrame: 4 weeks after treatment
Locations:
city: Leuven
country: Belgium
facility: Uz Leuven Dienst Nko
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: peter hellings, MD
role: PRINCIPAL_INVESTIGATOR
References: