Nouvelle etude de phase 2 pour NCX-1510

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

This study is not yet open for participant recruitment.
Verified by Biolipox AB September 2007
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 consumer health information

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment
Number of arms in study: 3

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]


Total Enrollment: 28

Study start: September 2007; Expected completion: 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



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 - 50 Years, Genders Eligible for Study: Both
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

Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00533637

Lennart Greiff, MD, PhD +46 46 211 09 68 lennart.greiff@skane.se

Sweden
Department of Otorhinolaryngology, Lund University Hospital, Lund, SE-221 85, Sweden
Lennart Greiff, MD, PhD +46 46 211 09 68 lennart.greiff@skane.se
Lennart Greiff, MD, PhD, Principal Investigator

Study chairs or principal investigators

Lennart Greiff, MD, PhD, Principal Investigator, University of Lund

More Information
Study ID Numbers: NLA-C004P
Last Updated: September 21, 2007
Record first received: September 20, 2007
ClinicalTrials.gov Identifier: NCT00533637
Health Authority: Sweden: Medical Products Agency
ClinicalTrials.gov processed this record on September 24, 2007

source :Clinicaltrials