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

NCT ID: NCT02238353

Last Updated: 2015-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Allergic Rhinitis; House Dust Mite Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

azelastine + fluticasone

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

Group Type: EXPERIMENTAL

azelastine + fluticasone

Intervention Type: DRUG

placebo

twice daily one puff in each nostril duration: 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

azelastine + fluticasone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

dymista

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

peter hellings, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Uz Leuven Dienst Nko

Leuven, Vlaams Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

emily dekimpe, Msc

Role: primary

emily.dekimpe@uzleuven.be

Other Identifiers

azelastine/fluticasone AZE/FLU

Identifier Type: -

Identifier Source: org_study_id