Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial

Overview

Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

Full Title of Study: “A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Olopatadine HCL Nasal Spray, 0.6%
    • Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
  • Drug: Fluticasone Propionate Nasal Spray, 50 mcg
    • Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Arms, Groups and Cohorts

  • Experimental: Olopatadine HCL Nasal Spray, 0.6%
    • Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
  • Active Comparator: Fluticasone Propionate Nasal Spray, 50 mcg
    • Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Clinical Trial Outcome Measures

Primary Measures

  • Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
    • Time Frame: 14 Days minus baseline
    • Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Reflective scores were assessed from the hour since the last dose of study medication.
  • Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline
    • Time Frame: 14 days minus baseline
    • Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12. Instantaneous scores were assessed at the time of daily dosing.
  • Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
    • Time Frame: 14 Days minus baseline
    • Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Reflective scores were assessed from the hour since the last dose of study medication.
  • Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
    • Time Frame: 14 Days minus baseline
    • Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9. Instantaneous scores were assessed at the time of daily dosing.

Participating in This Clinical Trial

Inclusion:

  • A history of spring/summer seasonal allergies. – Positive skin prick test for the currently prevalent allergen of the area. – Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article. – For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study. Exclusion: – History of chronic sinusitis. – Asthma, with the exception of intermittent asthma. – Smokers. – Known non-responders to antihistamines. – Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids. – Chronic use of long acting antihistamines. – Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1. – Relatives of study site staff or other individuals who had access to the clinical study protocol. – Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Dr. Michael Edwards, PhD, Alcon Laboratories, Inc.

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