Perennial (persistant) Allergic Rhinitis
Conditions
Interventions
Product Name: Loteprednol Etabonate Nasal Spray
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: Loteprednol etabonate
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
IVAX RESEARCH, INC.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Characterize the dose response relationship to mean change from baseline in average reflective Total Nasal Symptom Score (TNSS) for an investigational intranasal corticosteroid (LENS 200 mcg qPM, 400 qPM, and 400 qAM) compared to placebo administered for 28 days to patients 4 to 11 years old with PAR.;Secondary Objective: 1. Investigate the efficacy and safety and determine the onset of symptom relief for an investigational intranasal corticosteroid (LENS 200 mcg qPM, 400 qPM, and 400 qAM) compared to placebo administered for 28 days to patients 4 to 11 years old with PAR. 2. Perform an exploratory investigation to characterize the efficacy and safety of Flixonase™ 100 mcg qAM compared to an investigational intranasal corticosteroid (LENS 200 mcg qPM, 400 qPM, and 400 qAM) and placebo administered for 28 days to patients 4 to 11 years old with PAR. ;Primary end point(s): The primary efficacy endpoint will be the mean change from baseline in average TNSS over the entire 28-day treatment period. The average TNSS will be the mean of available AM and PM reflective scores from the evening of Treatment Days 1 through 28. The baseline average TNSS will be the mean of AM and PM scores during the run-in phase (Days -7 to the morning of Day 1) | — |
Countries
Slovakia
Outcome results
None listed