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Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

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ClinicalTrials.gov Identifier: NCT00578929
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : February 9, 2010
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
Alcon Research

Brief Summary:
A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Olopatadine Hydrochloride Nasal Spray 0.6% Drug: Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Study Start Date : September 2007
Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Olopatadine 0.6% 1 Spray
Olopatadine HCl 0.6% 1 spray per nostril twice daily
Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
Olopatadine HCl 1 or 2 sprays per nostril twice daily
Placebo Comparator: Vehicle 1 spray
Vehicle 1 spray per nostril twice daily
Drug: Vehicle
Vehicle 1 or 2 sprays per nostril twice daily
Experimental: Olopatadine 0.6% 2 sprays
Olopatadine HCl 0.6% 2 sprays per nostril twice daily
Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
Olopatadine HCl 1 or 2 sprays per nostril twice daily
Placebo Comparator: Vehicle 2 sprays
Vehicle 2 sprays per nostril twice daily
Drug: Vehicle
Vehicle 1 or 2 sprays per nostril twice daily



Primary Outcome Measures :
  1. Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) [ Time Frame: Baseline through 2 weeks after randomization ]

    Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score.

    The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.



Secondary Outcome Measures :
  1. Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) [ Time Frame: Baseline through 2 weeks after randomization ]

    Total Ocular Symptom Score comprised of scoring each of the following symptoms: itchy eyes and watery eyes. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 2 individual symptom scores were then added together for a total ocular symptom score.

    The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 2 individual scores averaged across all days.




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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female; minimum of 6 years of age and less than 12 years
  • 2 year history of seasonal allergic rhinitis

Exclusion Criteria:

  • Concurrent disease that might interfere with the investigation or evaluation of te study medication
  • Confirmed diagnosis of chronic rhinosinusitis within the last year
  • Asthma, with the exception of mild intermittent asthma
  • Anatomical nasal deformity
  • Nasal obstruction
  • Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
  • Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
  • Ocular disorder other that allergic conjunctivitis

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): NCT00578929


Locations
United States, Illinois
Kenilworth/IL
Kenilworth, Illinois, United States, 60043
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Ed Tumaian ed.tumaian@alconlabs.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Darrell Lange, Clinical Trial Manager, Alcon Research
ClinicalTrials.gov Identifier: NCT00578929     History of Changes
Other Study ID Numbers: C-07-01
First Posted: December 21, 2007    Key Record Dates
Results First Posted: February 9, 2010
Last Update Posted: March 2, 2010
Last Verified: February 2010

Keywords provided by Alcon Research:
allergic rhinitis
allergies
seasonal 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
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action