The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)

Phase 4

Completed

Conditions: Hypersensitivity

Interventions: Drug: levocetirizine
Drug: desloratadine
Drug: Levocetirizine placebo capsule
Drug: Desloratadine placebo tablet

Registration Number: NCT00359138

Lead Sponsor: Organon and Co

Brief Summary: This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class \> 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

Inclusion Criteria

Subjects must be 18 years of age or older, of either sex.
Subjects must have at least a history of positive skin testing to the allergens of tree pollen, grass pollen, house dust mite, or cat dander.
Non symptomatic volunteers allergic of different pollen they must be included out of the specific pollinic season.
Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
Subjects must understand and be able to adhere to visit schedules
Subjects must be in general good health.
Women of child-bearing potential must have a negative pregnancy test at Day -1 and must use an accepted method of contraception during the entire duration of the study.

Exclusion Criteria

Subjects who have persistent asthma.
Subjects who have chronic urticaria or atopic dermatosis.
Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization, or who must continue to receive treatment as listed below.

Medications Prohibited During the Trial and Washout Period Prior to Visit 1

Corticosteroids
- Intramuscular or intra-articular, 1 month
- Oral, inhaled, intravenous, rectal, intranasal, or ocular, 7 days
- High-potency dermatological, 7 days
Cromolyn/Lodoxamide/Nedocromil
- Intranasal, ocular, inhaled, or oral, 2 days
Antihistamines
- Long-acting prescription (eg, levocetirizine, fexofenadine, and desloratadine), 15 days
- Short-acting (eg, chlorpheniramine, brompheniramine including over-the-counter [OTC] forms, hydroxyzine), 15 days
- Ocular (eg, levocabastine), 15 days
Leukotriene inhibitors (eg, montelukast), 7 days
Systemic antibiotics, 14 days (the washout refers to antibiotics used to treat an upper or lower respiratory tract infection)
Immunotherapy (desensitization), 1 year
Decongestants
- oral, 2 days
- local, 2 days
Ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs; eg, Toradol), 5 days
Investigational medications, 30 days
Tricyclic antidepressants (eg, amitriptyline, clomipramine, doxepin, imipramine, trimipramine, amoxapine, desipramine, nortriptyline, protriptyline), 30 days
Tetracyclic antidepressants (eg, maprotiline, mirtazapine), 30 days
- Subjects with a history of hypersensitivity to desloratadine, to levocetirizine, or any of their excipients.
- Women who are breast-feeding, pregnant, or intend to become pregnant.
- Subjects with any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
- Subjects who have used any investigational drugs within 30 days of randomization.
- Subjects working between 11 PM and 8 AM (night shift).
- Subjects who have skin/color pigmentation incompatible with accurate measurements of flare reaction.
- Subjects with cutaneous hyperactivity: negative prick test control >3 mm.
- Subjects who are participating in any other clinical study.
- Subjects who are part of the staff personnel directly involved with this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desloratadine placebo tablet + Levocetirizine placebo capsule	Levocetirizine placebo capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine 5 mg tablet + Levocetirizine placebo capsule	Levocetirizine placebo capsule	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine placebo tablet + Levocetirizine 5 mg capsule	levocetirizine	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine placebo tablet + Levocetirizine 5 mg capsule	Desloratadine placebo tablet	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine placebo tablet + Levocetirizine placebo capsule	Desloratadine placebo tablet	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Desloratadine 5 mg tablet + Levocetirizine placebo capsule	desloratadine	Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

Primary Outcome Measures

Name	Time	Method
Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment	Starting at Day 8	The number of days after treatment discontinuation until a measurable wheal and flare response.

Secondary Outcome Measures