A double blind, randomized, placebo-controlled, parallel group, multicenter/multinational, efficacy and safety study of desloratadine 5 mg in the treatment of subjects with allergic rhinitis who meet the criteria for Persistent Allergic Rhinitis PER . - ND

Conditions: Persistent Allergic Rhinitis
MedDRA version: 8.1Level: LLTClassification code 10039085Term: Rhinitis allergic

Registration Number: EUCTR2005-005450-45-IT

Lead Sponsor: SCHERING-PLOUGH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

Subjects 12 years of age or older, of either sex with at least a 2 year history of allergic rhinitis who meet the criteria for PER defined as symptoms of allergic rhinitis that are present for four days or more per week and for four or more consecutive weeks per year .
Are the trial subjects under 18? yes
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

Subjects with history of anaphylaxis and/or severe local reactions to skin testing with allergens or with intolerable symptoms that would make partecipating in the study unbearable. Subjects who have had an upper respiratory tract that required antibiotic therapy, with asthma who require chronic use of inhaled or systemic corticosteroids or with clinically significan sinusitis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to compare the efficacy and safety of desloratadine with placebo in the symptomatic treatment of subjects 12 years and older with persistent allergic rhinitis PER .;Secondary Objective: The secondary objectives are to compare the effects of desloratadine to those of placebo on quality of life and impact on producity and health care utilization.;Primary end point(s): Symptoms Severity Rating Scale Assessment severity scores for five T5SS individual allergic rhinitis signs/symptoms nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritus and ocular pruritus will be recorded on subject daily diaries. Symptom Severity Visual Analogue Scale VAS Assessment. Evaluation of Therapeutic Response to treatment. Rhinoconjunctivitis Quality of life Questionnaire. Interference with Sleep and with Activities of Daily Living. Pharmacoeconomic Questionnaire. Adverse Events.

Secondary Outcome Measures