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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • NLA Nasal Spray
• Active Comparator: 2
• Placebo Comparator: 3

Primary Measures

• Taste perversion scores
  • Time Frame: 7 days
    
• Local tolerance scores
  • Time Frame: 7 days
    

Secondary Measures

• Treatment efficacy
  • Time Frame: 1 days
    
• Type and incidence of AEs
  • Time Frame: 7 days
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biolipox AB

Overall Clinical Trial Officials and Contacts

Lennart Greiff, MD, PhD Principal Investigator University of Lund  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00533637

Study ID Number: NLA-C004P

ClinicalTrials.gov Identifier: NCT00533637

Health Authority: Sweden: Medical Products Agency