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

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ClinicalTrials.gov Identifier: NCT00691665
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : March 10, 2010
Last Update Posted : March 30, 2010
Sponsor:
Information provided by:
Alcon Research

Brief Summary:
Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2008
Actual Primary Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691665


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

Responsible Party: Dr. Michael Edwards, PhD, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00691665     History of Changes
Other Study ID Numbers: SMA-08-06
First Posted: June 5, 2008    Key Record Dates
Results First Posted: March 10, 2010
Last Update Posted: March 30, 2010
Last Verified: March 2010

Keywords provided by Alcon Research:
Rhinitis
Seasonal Allergic Rhinitis
allergies

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Olopatadine Hydrochloride
Anti-Inflammatory Agents
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
Histamine H1 Antagonists
Histamine Antagonists