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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00578929
First received: December 19, 2007
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
Drug: Olopatadine Hydrochloride Nasal Spray 0.6%
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS) [ Time Frame: Baseline through 2 weeks after randomization ] [ Designated as safety issue: No ]

    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:
  • Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS) [ Time Frame: Baseline through 2 weeks after randomization ] [ Designated as safety issue: No ]

    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.



Enrollment: 2388
Study Start Date: September 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Alcon Research

Additional 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
Study First Received: December 19, 2007
Results First Received: January 14, 2010
Last Updated: February 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
allergic rhinitis
allergies
seasonal allergies

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Olopatadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014