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

NCT00533637 | Completed Phase 2

• 1 other identifier: NLA-C004P
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis; Nasal spray; Anti-histamine; Tolerability

Outcome Measures

Primary Outcomes (2)

• Taste perversion scores

  7 days

• Local tolerance scores

  7 days

Secondary Outcomes (2)

• Treatment efficacy

  1 days

• Type and incidence of AEs

  7 days

Study Arms (3)

1

EXPERIMENTAL

NLA Nasal Spray

Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation

2

ACTIVE COMPARATOR

Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cetirizine dihydrochloride (10 mg/ml) liposomal formulation DRUG

2x110μL in each nostril twice daily for 7 days

1

Cetirizine dihydrochloride (10 mg/ml) buffer solution DRUG

2x110μL in each nostril, as a single dose

2

Placebo DRUG

Citrate buffer with preservatives

3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Blood donation during the last three months

Sponsors & Collaborators

• Biolipox AB: lead

Study Sites (1)

Department of Otorhinolaryngology, Lund University Hospital

Lund, SE-221 85, Sweden

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lennart Greiff, MD, PhD

  University of Lund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 5, 2008

Record last verified: 2007-09

Locations

SE (1)