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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Olopatadine Hydrochloride Nasal Spray 0.6%
Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring allergic rhinitis, allergies, seasonal allergies

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kenilworth/IL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Olopatadine 0.6% 1 Spray

Vehicle 1 spray

Olopatadine 0.6% 2 sprays

Vehicle 2 sprays

Arm Description

Olopatadine HCl 0.6% 1 spray per nostril twice daily

Vehicle 1 spray per nostril twice daily

Olopatadine HCl 0.6% 2 sprays per nostril twice daily

Vehicle 2 sprays per nostril twice daily

Outcomes

Primary Outcome Measures

Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
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)
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.

Full Information

First Posted
December 19, 2007
Last Updated
February 23, 2010
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00578929
Brief Title
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Official Title
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
allergic rhinitis, allergies, seasonal allergies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olopatadine 0.6% 1 Spray
Arm Type
Experimental
Arm Description
Olopatadine HCl 0.6% 1 spray per nostril twice daily
Arm Title
Vehicle 1 spray
Arm Type
Placebo Comparator
Arm Description
Vehicle 1 spray per nostril twice daily
Arm Title
Olopatadine 0.6% 2 sprays
Arm Type
Experimental
Arm Description
Olopatadine HCl 0.6% 2 sprays per nostril twice daily
Arm Title
Vehicle 2 sprays
Arm Type
Placebo Comparator
Arm Description
Vehicle 2 sprays per nostril twice daily
Intervention Type
Drug
Intervention Name(s)
Olopatadine Hydrochloride Nasal Spray 0.6%
Intervention Description
Olopatadine HCl 1 or 2 sprays per nostril twice daily
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle 1 or 2 sprays per nostril twice daily
Primary Outcome Measure Information:
Title
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)
Description
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.
Time Frame
Baseline through 2 weeks after randomization
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)
Description
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.
Time Frame
Baseline through 2 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ed Tumaian
Organizational Affiliation
ed.tumaian@alconlabs.com
Official's Role
Study Director
Facility Information:
Facility Name
Kenilworth/IL
City
Kenilworth
State/Province
Illinois
ZIP/Postal Code
60043
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21477426
Citation
Meltzer EO, Blaiss M, Fairchild CJ. Comprehensive report of olopatadine 0.6% nasal spray as treatment for children with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 May-Jun;32(3):213-20. doi: 10.2500/aap.2011.32.3448. Epub 2011 Apr 8.
Results Reference
derived

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

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