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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00578929
• Other study ID #: C-07-01
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2007
• Last updated: February 23, 2010
• Start date: September 2007

Study information

• Verified date: February 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2388
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Olopatadine Hydrochloride Nasal Spray 0.6%
Olopatadine HCl 1 or 2 sprays per nostril twice daily
• Vehicle
Vehicle 1 or 2 sprays per nostril twice daily

Locations

Country	Name	City	State
United States	Kenilworth/IL	Kenilworth	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through 2 weeks after randomization	No
Secondary	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.	Baseline through 2 weeks after randomization	No