Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis - Full Text View

Sponsored by:	Biolipox AB
Information provided by:	Biolipox AB
ClinicalTrials.gov Identifier:	NCT00533637

Purpose

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

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution Drug: Placebo	Phase II

MedlinePlus related topics: Taste and Smell Disorders

Drug Information available for: Citric acid Sodium Citrate Cetirizine Cetirizine hydrochloride Histamine Histamine dihydrochloride Histamine phosphate

U.S. FDA Resources

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

Further study details as provided by Biolipox AB:

Primary Outcome Measures:

Taste perversion scores [ Time Frame: 7 days ]
Local tolerance scores [ Time Frame: 7 days ]

Secondary Outcome Measures:

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

Enrollment:	28
Study Start Date:	September 2007
Study Completion Date:	December 2007

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533637

Locations

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

Sponsors and Collaborators

Biolipox AB

Investigators

Principal Investigator:

Lennart Greiff, MD, PhD

University of Lund

More Information

Study ID Numbers:	NLA-C004P
Study First Received:	September 20, 2007
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00533637
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Biolipox AB:

Allergic rhinitis
Nasal spray
Anti-histamine
Tolerability

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Citric Acid

Histamine phosphate
Rhinitis
Cetirizine
Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Therapeutic Uses
Physiological Effects of Drugs
Histamine Agents

Histamine H1 Antagonists
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009