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

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Cetirizine dihydrochloride (10 mg/ml) liposomal formulation

Cetirizine dihydrochloride (10 mg/ml) buffer solution

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinitis, Nasal spray, Anti-histamine, Tolerability

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Otorhinolaryngology, Lund University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

NLA Nasal Spray

Outcomes

Primary Outcome Measures

Taste perversion scores

Local tolerance scores

Secondary Outcome Measures

Treatment efficacy

Type and incidence of AEs

Full Information

NCT ID

NCT00533637

First Posted

September 20, 2007

Last Updated

February 29, 2008

Sponsor

Biolipox AB

1. Study Identification

Unique Protocol Identification Number

NCT00533637

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Biolipox AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic rhinitis, Nasal spray, Anti-histamine, Tolerability

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

NLA Nasal Spray

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Cetirizine dihydrochloride (10 mg/ml) liposomal formulation

Intervention Description

2x110μL in each nostril twice daily for 7 days

Intervention Type

Drug

Intervention Name(s)

Cetirizine dihydrochloride (10 mg/ml) buffer solution

Intervention Description

2x110μL in each nostril, as a single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Citrate buffer with preservatives

Primary Outcome Measure Information:

Title

Taste perversion scores

Time Frame

7 days

Title

Local tolerance scores

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Treatment efficacy

Time Frame

1 days

Title

Type and incidence of AEs

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lennart Greiff, MD, PhD

Organizational Affiliation

University of Lund

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Otorhinolaryngology, Lund University Hospital

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

12. IPD Sharing Statement

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

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