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Completed

NCT Number: NCT00691665

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

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sacramento, CA

Sacramento, California, 95819, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olopatadine HCL Nasal Spray, 0.6%

Drug

Olopatadine HCL Nasal Spray, 0.6% 2 sprays per nostril twice daily

Fluticasone Propionate Nasal Spray, 50 mcg

Drug

Fluticasone Propionate Nasal Spray, 50 mcg 2 sprays per nostril once daily

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
First posted
Jun 5, 2008
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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