AZELASTINE/FLUTICASONE (AZE/FLU) Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)
Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis; House Dust Mite Allergy
Intervention: azelastine + fluticasone (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Universitaire Ziekenhuizen Leuven Official(s) and/or principal investigator(s): peter hellings, MD, Principal Investigator, Affiliation: uz leuven
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.
Clinical Details
Official title: AZE/FLU Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: change in expression of inflammatory mediators (Histamine / Substance P / IL-5 / EPO)
Secondary outcome: change in PNIF values upon CDA exposure
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
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Uz Leuven Dienst Nko, Leuven, Vlaams Brabant 3000, Belgium; Recruiting emily dekimpe, Msc, Email: emily.dekimpe@uzleuven.be peters hellings, MD, Principal Investigator
Additional Information
Starting date: October 2014
Last updated: November 7, 2014
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