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

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ClinicalTrials.gov Identifier: NCT02238353
Recruitment Status : Unknown
Verified December 2015 by Universitaire Ziekenhuizen KU Leuven.
Recruitment status was:  Recruiting
First Posted : September 12, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis House Dust Mite Allergy Drug: azelastine + fluticasone Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: AZE/FLU Nasal Spray on Symptom Control, Nasal Mediators and Nasal Hyperresponsiveness in Allergic Rhinitis (AR)
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: azelastine + fluticasone
azelastine 137 µg + fluticasone 50 µg combined applied twice daily one puff in each nostril duration: 4 weeks
 Drug: azelastine + fluticasone
Other Name: dymista
Placebo Comparator: placebo
twice daily one puff in each nostril duration: 4 weeks
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. change in expression of inflammatory mediators (Histamine / Substance P / IL-5 / EPO) [ Time Frame: 4 weeks after treatment ]

    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 :
  1. change in PNIF values upon CDA exposure [ Time Frame: 4 weeks treatment ]

    Nasal hyperreactivity (NHR) can be assessed with peak nasal inspiratory flow (PNIF) measurement before and after cold dry air (CDA) provocation.

    1. 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.
    2. 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



Other Outcome Measures:
  1. 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) [ Time Frame: 1 week after treatment ]

    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.


  2. Effects of therapy with AZE/FP or placebo on nasal inflammatory mediators (Histamine / Substance P (SP) / IL-5 / EPO) [ Time Frame: one week after treatment ]

    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


  3. change in PNIF values upon CDA exposure [ Time Frame: 1 week of treatment ]

    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


  4. change in assessment of visual analogue scale (VAS) for total nasal symptom (TNS) and individual nasal symptoms, rT5SS and Allergic Rhinitis Control Test (ARCT) [ Time Frame: 4 weeks after treatment ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238353


Locations
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Belgium
Uz Leuven Dienst Nko Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: emily dekimpe, Msc       emily.dekimpe@uzleuven.be   
Principal Investigator: peters hellings, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Investigators
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Principal Investigator: peter hellings, MD UZ Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT02238353    
Other Study ID Numbers: azelastine/fluticasone AZE/FLU
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Azelastine
Anti-Inflammatory Agents
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents