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

ClinicalTrials.gov processed this record on August 28, 2014