A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, DOSE RANGING STUDY TO DETERMINE THE EFFICACY AND SAFETY OF AN INVESTIGATIONAL INTRANASAL CORTICOSTEROID COMPARED TO PLACEBO AND OPEN-LABEL FLUTICASONE PROPIONATE AQUEOUS NASAL SPRAY (FLIXONASE™) ADMINISTERED FOR 28 DAYS TO PATIENTS 4 to 11 YEARS OLD WITH PERENNIAL ALLERGIC RHINITIS - LENS Peds PAR Study

Phase 1

• Conditions: Perennial (persistant) Allergic Rhinitis

• Registration Number: EUCTR2005-000006-32-SK
• Lead Sponsor: IVAX RESEARCH, INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-01
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

1.Is male or a pre-menarchal female, 4 to 11 years old, inclusive, at Visit 1

2. Has a medical history (written or verbal confirmation) of PAR for =1 year prior to Visit 1.

3. Has a positive skin prick test response to the same perennial allergen (e.g., dust mites, cockroach, mold, or animal dander) consistent with their medical history and is present in the patient’s environment. The skin test must have been performed within 12 months of Visit 1. A positive response is defined as the wheal (excluding flare) diameter l3 mm larger than the diluent control (saline or sterile water).

If the patient is on immunotherapy, a skin prick test must be performed even if a historical test is available.

4. Is in good general health (defined by no abnormalities that, in the opinion of the Investigator, would place the patient at risk or affect the study outcome) as determined by medical history, physical exam findings, and/or laboratory results.

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

Exclusion Criteria

1. Has a history or evidence of a clinically significant, unstable, and/or uncontrolled disease, which, in the judgment of the Investigator, could interfere with the study and/or require treatment that would interfere with the study.

2. Has a history or current evidence of congenital cataracts, glaucoma, and/or ocular herpes simplex.

3. Has a history or current evidence of acute or clinically significant chronic sinusitis, infectious rhinitis, rhinitis medicamentosa, or atrophic rhinitis. Patients with coexisting SAR are eligible provided the patient’s SAR clearly indicates an exacerbation due to seasonal aeroallergens.

Study & Design

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