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

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ClinicalTrials.gov Identifier: NCT00533637
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : March 5, 2008
Sponsor:
Information provided by:
Biolipox AB

Tracking Information
First Submitted Date  ICMJE September 20, 2007
First Posted Date  ICMJE September 21, 2007
Last Update Posted Date March 5, 2008
Study Start Date  ICMJE September 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
  • Taste perversion scores [ Time Frame: 7 days ]
  • Local tolerance scores [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
  • Treatment efficacy [ Time Frame: 1 days ]
  • Type and incidence of AEs [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Taste and Local Tolerance Study of NLA Nasal Spray in Patients With Allergic Rhinitis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation
    2x110μL in each nostril twice daily for 7 days
  • Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution
    2x110μL in each nostril, as a single dose
  • Drug: Placebo
    Citrate buffer with preservatives
Study Arms  ICMJE
  • Experimental: 1
    NLA Nasal Spray
    Intervention: Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation
  • Active Comparator: 2
    Intervention: Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 20, 2007)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00533637
Other Study ID Numbers  ICMJE NLA-C004P
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Biolipox AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lennart Greiff, MD, PhD University of Lund
PRS Account Biolipox AB
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP