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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biolipox AB
• Treatments: Cetirizine

Criteria

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