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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533637
• Other study ID #: NLA-C004P
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2007
• Last updated: February 29, 2008
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2007
• Source: Biolipox AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Cetirizine dihydrochloride (10 mg/ml) liposomal formulation
2x110µL in each nostril twice daily for 7 days
• Cetirizine dihydrochloride (10 mg/ml) buffer solution
2x110µL in each nostril, as a single dose
• Placebo
Citrate buffer with preservatives

Locations

Country	Name	City	State
Sweden	Department of Otorhinolaryngology, Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Biolipox AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taste perversion scores		7 days
Primary	Local tolerance scores		7 days
Secondary	Treatment efficacy		1 days
Secondary	Type and incidence of AEs		7 days