A Phase 2 interventional study of Cetirizine dihydrochloride (10 mg/ml) liposomal formulation and Cetirizine dihydrochloride (10 mg/ml) buffer solution in Allergic Rhinitis, sponsored by Biolipox AB. Completed at 1 site in Sweden. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2008-03-05.
Sponsored by Biolipox AB · Phase 2, Interventional, and Treatment
Evaluation of NLA Nasal Spray with regard to taste perversion and local tolerance
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.
1,042 studies on the registry are indexed under Rhinitis, Allergic; 91 are open to participants now.
This study's enrollment of 28 is below the median of 90 across 858 interventional studies indexed under Rhinitis, Allergic.
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Exclusion Criteria:
NLA Nasal Spray
Drug: Cetirizine dihydrochloride (10 mg/ml) liposomal formulation
Drug: Cetirizine dihydrochloride (10 mg/ml) buffer solution
Drug: Placebo
2x110μL in each nostril twice daily for 7 days
2x110μL in each nostril, as a single dose
Citrate buffer with preservatives
Taste perversion scores
Time frame: 7 days
Local tolerance scores
Time frame: 7 days
Treatment efficacy
Time frame: 1 days
Type and incidence of AEs
Time frame: 7 days
This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.
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