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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00691665
First received: June 3, 2008
Last updated: March 23, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Olopatadine HCL Nasal Spray, 0.6%
Drug: Fluticasone Propionate Nasal Spray, 50 mcg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline [ Time Frame: 14 Days minus baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 130
Study Start Date: May 2008
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olopatadine HCL Nasal Spray, 0.6%
Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily
Drug: 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
Drug: Fluticasone Propionate Nasal Spray, 50 mcg
Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691665

Locations
United States, California
Sacramento, CA
Sacramento, California, United States, 95819
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Dr. Michael Edwards, PhD, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00691665     History of Changes
Other Study ID Numbers: SMA-08-06
Study First Received: June 3, 2008
Results First Received: January 26, 2010
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Rhinitis
Seasonal Allergic Rhinitis
allergies

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Olopatadine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on August 28, 2014