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

Primary Purpose

Allergic Rhinitis, House Dust Mite Allergy

Status

Unknown status

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

azelastine + fluticasone

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Uz Leuven Dienst NkoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

azelastine + fluticasone

placebo

Arm Description

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

twice daily one puff in each nostril duration: 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in PNIF values upon CDA exposure

Nasal hyperreactivity (NHR) can be assessed with peak nasal inspiratory flow (PNIF) measurement before and after cold dry air (CDA) provocation. Peak nasal inspiratory flow (PNIF) Peak nasal inspiratory flow evaluation is a physiologic measure of air flow through both nasal cavities during forced inspiration. The PNIF can be measured using a portable nasal inspiratory ﬂow meter and is expressed in liters per minute. Cold dry air (CDA) provocation CDA nasal provocation can be performed by delivering compressed dry air through a mask placed over nose and mouth of the patient, while breathing only through the nose. Patients will be exposed during 15 minutes. NHR is defined as a drop in PNIF larger than 20 % from baseline upon CDA challenge. The efficacy of MP29-02 treatment will be evaluated by measuring the change in PNIF values upon CDA exposure in both treatment arms. Unit of measurement of PNIF: L/min

Full Information

NCT ID

NCT02238353

First Posted

August 22, 2013

Last Updated

December 2, 2015

Sponsor

Universitaire Ziekenhuizen KU Leuven

1. Study Identification

Unique Protocol Identification Number

NCT02238353

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, House Dust Mite Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

azelastine + fluticasone

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

twice daily one puff in each nostril duration: 4 weeks

Intervention Type

Drug

Intervention Name(s)

azelastine + fluticasone

Other Intervention Name(s)

dymista

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 weeks after treatment

Secondary Outcome Measure Information:

Title

change in PNIF values upon CDA exposure

Description

Time Frame

4 weeks treatment

Other Pre-specified Outcome Measures:

Title

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)

Description

A Visual Analogue Scale (VAS) is a measurement of patient's subjective evaluation of symptom severity. Patients will score the severity of their total nasal symptoms (TNS) on a scale, as well as each individual nasal symptom (rhinorrhea, pruritis, sneezing, nasal obstruction), with 0 meaning no symptoms and 10 meaning the worst symptoms. The cut off value of 5/10 is to distinguish between controlled and uncontrolled AR. Patients will score their reflective nasal and ocular symptoms on a 4-point scale from absent (0), mild (1), moderate (2) to severe (3)). Minimum score: 0/15 as having no trouble with any of the symptoms; and maximum score: 15/15 as having maximum trouble with all the symptoms The Allergic Rhinitis Control Test (ARCT): Patients score the five questions from 1 (always troublesome) to 5 (never troublesome). Minimum score: 5/25 ; maximum score: 25/25. A score from 5/25 to 20/25 is assumed not controlled AR; a score higher then 20/25 is assumed controlled.

Time Frame

1 week after treatment

Title

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

Description

Change in expression of inflammatory mediators (Histamine / Substance P / IL-5 / EPO) at after 1 week of therapy with AZE/FP or placebo nasal spray. Unit of measurement: µg/ml

Time Frame

one week after treatment

Title

change in PNIF values upon CDA exposure

Description

Time Frame

1 week of treatment

Title

change in assessment of visual analogue scale (VAS) for total nasal symptom (TNS) and individual nasal symptoms, rT5SS and Allergic Rhinitis Control Test (ARCT)

Description

Time Frame

4 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

peter hellings, MD

Organizational Affiliation

UZ Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uz Leuven Dienst Nko

City

Leuven

State/Province

Vlaams Brabant

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

emily dekimpe, Msc

emily.dekimpe@uzleuven.be

First Name & Middle Initial & Last Name & Degree

peters hellings, MD

12. IPD Sharing Statement

Learn more about this trial

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

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