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

This study has been completed.
Sponsor:
Information provided by:
Biolipox AB
ClinicalTrials.gov Identifier:
NCT00533637
First received: September 20, 2007
Last updated: February 29, 2008
Last verified: September 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Biolipox AB:
Allergic rhinitis
Nasal spray
Anti-histamine
Tolerability

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
 Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013