Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis

Study Overview
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Brief Summary
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Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance

Detailed Description
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Oral or intranasal antihistamines is the first line treatment for allergic rhinitis. Cetirizine is a second-generation selective antihistamine widely used in an oral formulation for the treatment of allergic rhinitis. Local administration of cetirizine has been shown to reduce symptoms after allergen challenge, and has the potential to shorten the time to onset and decrease systemic side effects. However, local irritation and nasal burning/pain has been reported after nasal administration. For the compliance of the patients taking a nasal spray, the taste and tolerance of the product is of particular importance. NLA Nasal Spray contains cetirizine in a liposomal formulation aiming to improve the tolerability. The present study aims to compare the NLA Nasal Spray with cetirizine in an aqueous formulation and placebo with regard to taste perversion and local tolerance. This will be investigated off-season in patients with seasonal allergic rhinitis after provocation with allergen.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Cross-Over, Allergen Challenge Study to Evaluate Taste and Local Tolerance of NLA Nasal Spray in Patients With Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation
* Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 50 years of age (inclusive) Body Mass Index (BMI) between 18 and 28 kg/m2 History of pollen-induced seasonal allergic rhinitis for at least two years and otherwise healthy Elevated specific IgE to at least one aero allergen or at least one positive skin pick test (SPT) Seasonal allergic rhinitis with symptoms provoked by the allergen with a corresponding elevated specific IgE or positive SPT Signed written Informed Consent Exclusion Criteria: Perennial allergic rhinitis except for cat and/or dog sensitivity under the condition that these patients are not exposed to cats and dogs Soy bean allergy Peanut allergy Smoking during the last month before study inclusion Any upper respiratory tract infection during the period of 2 weeks before the start of the study Chronic medication Any medication, including herbal medicines, during their last five half-lives (t½) Nasal anatomical deviations Extensive use of nasal sprays as judged by the Investigator Ongoing nasal symptoms as judged by the Investigator Known hypersensitivity to cetirizine Pregnant or breast-feeding women Fertile women not using reliable methods of contraception (i.e. IUD, barrier method, hormonal contraceptives, abstinence) Participation in any other investigational study in the last three months Inability to adhere to the study plan Previous inclusion in this study Blood donation during the last three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>NLA Nasal Spray | Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation<br>* 2x110μL in each nostril twice daily for 7 days<br>|
| Active Comparator: 2<br> | Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution<br>* 2x110μL in each nostril, as a single dose<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Citrate buffer with preservatives<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste perversion scores |  | 7 days | 
| Local tolerance scores |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy |  | 1 days | 
| Type and incidence of AEs |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, Nasal spray, Anti-histamine, Tolerability