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

NCT02238353 | Unknown Phase 4

• 1 other identifier: azelastine/fluticasone AZE/FLU
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; House Dust Mite Allergy

Outcome Measures

Primary Outcomes (1)

• change in expression of inflammatory mediators (Histamine / Substance P / IL-5 / EPO)

  Change in expression of inflammatory mediators (Histamine / Substance P / interleukin 5 (IL-5) / EPO) at after 4 weeks of therapy with AZE/FP or placebo nasal spray. Unit of measurement: µg/ml

  4 weeks after treatment

Secondary Outcomes (1)

• change in PNIF values upon CDA exposure

  4 weeks treatment

Other Outcomes (4)

• 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)

  1 week after treatment

• Effects of therapy with AZE/FP or placebo on nasal inflammatory mediators (Histamine / Substance P (SP) / IL-5 / EPO)

  one week after treatment

• change in PNIF values upon CDA exposure

  1 week of treatment

Study Arms (2)

azelastine + fluticasone

EXPERIMENTAL

azelastine 137 µg + fluticasone 50 µg combined applied twice daily one puff in each nostril duration: 4 weeks

Drug: azelastine + fluticasone

placebo

PLACEBO COMPARATOR

twice daily one puff in each nostril duration: 4 weeks

Drug: Placebo

Interventions

azelastine + fluticasone DRUG

Also known as: dymista

azelastine + fluticasone

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Uz Leuven Dienst Nko

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic; Dust Mite Allergy

Interventions

azelastine; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• peter hellings, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 12, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

BE (1)