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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Olopatadine Hydrochloride Nasal Spray 0.6%; Drug: Vehicle

• Registration Number: NCT00578929
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-21
• Primary Completion: 2008-11
• Results First Submitted: 2010-01-14
• Results First Submitted QC: 2010-01-14
• Status Verified: 2010-02
• Results First Posted: 2010-02-09
• Last Update Submitted: 2010-02-23
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2388

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olopatadine 0.6% 1 Spray	Olopatadine Hydrochloride Nasal Spray 0.6%	Olopatadine HCl 0.6% 1 spray per nostril twice daily
Vehicle 1 spray	Vehicle	Vehicle 1 spray per nostril twice daily
Olopatadine 0.6% 2 sprays	Olopatadine Hydrochloride Nasal Spray 0.6%	Olopatadine HCl 0.6% 2 sprays per nostril twice daily
Vehicle 2 sprays	Vehicle	Vehicle 2 sprays per nostril twice daily

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in the Reflective Total Nasal Symptom Score (TNSS)	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

Name	Time	Method
Percent Change From Baseline in the Reflective Total Ocular Symptom Score (TOSS)	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.

Trial Locations

Locations (1)

Kenilworth/IL; 🇺🇸 Kenilworth, Illinois, United States