Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis
Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis
Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance
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.
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