A monocenter, double-blind, randomized trial, with two parallel groups comparing the clinical efficacy of levocetirizine 5 mg capsules and desloratadine 5 mg capsules taken once a day over 3 weeks of treatment in adult subjects suffering from seasonal allergic rhinitis (SAR) due to grass polle

• Conditions: Adult subjects suffering from seasonal allergic rhinitis (SAR) due to grass pollen; MedDRA version: 7.1Level: LLTClassification code 10039776

• Registration Number: EUCTR2004-002971-18-DE
• Lead Sponsor: CB S.A. Pharma Sector

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

The subjects should meet the following criteria at V1 (or at pre-screening visit (V0) when applicable):

•Have been informed of the nature and aims of the study (refer to ICF) and have given their written informed consent signed and dated (at V1 or at pre-screening visit (V0)).

•At least 2-year history of SAR that became symptomatic during annual from grass pollen season and requiring treatment (also at least since 2 years) during annual from grass pollen.

•Adult subjects older than 18 years of either sex.

•Out-patients.

•Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (= 3.5 IU/ml) to grass pollen (less than 1 year).

•Female subjects of childbearing potential must agree not to become pregnant during the study. Female subjects are considered of non-childbearing potential before menarche, or at least two years after menopause, or if they had a total hysterectomy or a bilateral ovariectomy or a congenital sterility. When sexually active, females of childbearing potential must be using a medically accepted contraceptive method (hormonal birth control, per os, injectable or by implant, for at least 2 months), have had a bilateral tubal ligation, have monogamous relationship with vasectomized partner or agree to use intrauterine device, diaphragm with spermicide or male condom with spermicide. The female subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive medthod, and undertake to inform the Investigator of any potential change in status. Female subjects with childbearing potential are eligible if they have a negative urine pregancy test at V1.

•Subjects considered as reliable and mentally capable of adhering to the protocol (i.e., completing the daily record card), according to the judgement of the Investigator (at V1 or at pre-screening visit (V0)).

The subjects should meet the following criteria at V2:

•Minimum mean T5SS of 8 during the baseline 3 to 7 days period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To enter the study at Visit 1, the subjects should not:

•Be pregnant (positive urinary pregnancy test) or lactating.

•Have an ear, nose and throat (ENT) or eye infection during the two weeks preceding visit 1 (e.g., sinusitis, purulent rhinorrhea, common cold, ...)

•Have an associated asthma requiring a daily treatment other than ß2 short acting agonist prn

•Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids

•Have an associated ENT disease such as vasomotor rhinitis, significant chronic sinusitis, obstructive nasal polyposis, obstructive deviation of the nasal septum, rhinitis medicamentosa

•Have another clinically significant disease (e.g. cardiovascular, hepatic, renal, auto-immune or associated with haematology, neurology, psychiatry) or any other disease which would disturb absorption, distribution, metabolism or excretion of the investigational products.

•Be incapable of giving their written informed consent

•Be initiating or changing the dose of an immunotherapy regimen during the course of the study or during the month preceding visit 1.

•Intake of medications prohibited before the screening visit V1, with the following wash-out periods:
•intranasal or systemic corticosteroids (30 days)
•ketotifen (14 days)
•nedocromil or cromoglycate (14 days)
•topical corticosteroids (14 days)
•loratadine, desloratadine (10 days)
•leukotriene antagonist or synthesis inhibitors (7 days)
•H1 antihistamines (3 days)
•decongestants (per os, nasal sprays or drops) (3 days)

•Be hypersensive to levocetirizine or its excipients, desloratadine or to any other piperazine derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine.

•Be expected non compliant with the investigational products or with the protocol requirements

•Have a known lack of response to H1- antihistamines,

•Have an history of alcoholism, drug addiction, mental instability,

•Have participated in a clinical trial during the last three months before V1,

•Have already been selected in this trial

•Subjects intending to donate blood during the trial

•The investigator, co-investigators, as well their children or spouses and all the study collaborators should not be enrolled in this study.

To continue the study at Visit 2, the subjects should not:

•Have a selection period (Visit 1-Visit 2) inferior to three days or superior to seven days

•Have a mean T5SS < 8 over the selection period

•Have taken any prohibited medication during the selection period

•Have presented during the selection period with any of the exclusion criteria checked at Visit 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified