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

NCT ID: NCT00533637

Last Updated: 2008-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-12-31

Brief Summary

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

Detailed Description

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

NLA Nasal Spray

Group Type: EXPERIMENTAL

Cetirizine dihydrochloride (10 mg/ml) liposomal formulation

Intervention Type: DRUG

2x110μL in each nostril twice daily for 7 days

2

Group Type: ACTIVE_COMPARATOR

Cetirizine dihydrochloride (10 mg/ml) buffer solution

Intervention Type: DRUG

2x110μL in each nostril, as a single dose

3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Citrate buffer with preservatives

Interventions

Cetirizine dihydrochloride (10 mg/ml) liposomal formulation

2x110μL in each nostril twice daily for 7 days

Intervention Type: DRUG

Cetirizine dihydrochloride (10 mg/ml) buffer solution

2x110μL in each nostril, as a single dose

Intervention Type: DRUG

Placebo

Citrate buffer with preservatives

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biolipox AB

INDUSTRY

Sponsor Role: lead

Principal Investigators

Lennart Greiff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lund

Locations

Department of Otorhinolaryngology, Lund University Hospital

Lund, , Sweden

Countries

Sweden

Other Identifiers

NLA-C004P

Identifier Type: -

Identifier Source: org_study_id