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

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation; Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-221 85
    • Department of Otorhinolaryngology, Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Taste perversion scores	7 days
Local tolerance scores	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biolipox AB
• Investigators: Principal Investigator: Lennart Greiff, MD, PhD, University of Lund

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 20, 2007
• First Submitted That Met QC Criteria: September 20, 2007
• First Posted (Estimate): September 21, 2007

Study Record Updates

• Last Update Posted (Estimate): March 5, 2008
• Last Update Submitted That Met QC Criteria: February 29, 2008
• Last Verified: September 1, 2007

More Information

Terms related to this study

• Keywords: Tolerability; Allergic rhinitis; Anti-histamine; Nasal spray
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine
• Other Study ID Numbers: NLA-C004P