Ocular Symptoms Associated with Seasonal Allergic Rhinitis
Conditions
Interventions
Trade Name: Flonase
Product Name: flonase
Pharmaceutical Form: Nasal spray
INN or Proposed INN: FLUTICASONE PROPIONATE
CAS Number: 80474-14-2
Current Sponsor code: RH01619
Other descriptive name: FLUT
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consent/Assent Aged at least 12 years at Visit 2 (Screening/Placebo Lead-in Visit). Compliance General Health Diagnosis of seasonal allergic rhinitis Allergic rhinitis symptom of at least moderate severity for randomization The subject resided within a geographical environment where exposure to mountain cedar pollen was significant during the entire study period. Contraception Are the trial subjects under 18? yes Number of subjects for this age range: 75 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 626 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy Breast-feeding Allergy/Intolerance Nasal disorders Disease Infection Impairments limiting participation Medication Clinical Study/Experimental Medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate that a 14-day course of FP200QD is superior to placebo in relieving ocular symptoms associated with AR as determined by mean change from baseline in subject-rated reflective total ocular symptom scores (rTOSS);Secondary Objective: to evaluate FP compared to placebo in terms of: ? Mean change from baseline in both the AM rTOSS and PM rTOSS; ? Mean change from baseline in both the individual AM reflective symptom score and the PM reflective symptom score for each symptom of itching/burning, tearing/watering, redness; ? Mean change from baseline in AM pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS); ? End-of-treatment assessment of response to therapy for ocular symptoms; ? Impact of rhinitis on activities of daily living and overall well-being using the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) variables, overall scores, and individual domains. ? Mean change from baseline in daily Reflective Nasal Congestion Symptom Score (rNCSS); ? Objective assessment of conjunctival redness.;Primary end point(s): Mean change from baseline in rTOSS for a 14-day course.;Timepoint(s) of evaluation of this end point: . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change from baseline in both the AM rTOSS and PM rTOSS; ? Mean change from baseline in both the individual AM reflective and PM reflective ocular symptom scores for each symptom of itching/burning, tearing/watering, redness; ? Mean change from baseline in AM pre-dose iTOSS; ? End-of-treatment assessment of response to therapy for ocular symptoms; ? Impact of rhinitis on activities of daily living and overall well-being using the MiniRQLQ variables, overall scores, and individual domains. ? Mean change from baseline in daily rNCSS; ? Objective assessment of conjunctival redness;;Timepoint(s) of evaluation of this end point: . | — |
Countries
United States
Outcome results
None listed