Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid

Seasonal Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845195
• Other study ID #: SMA-08-23
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2009
• Last updated: April 22, 2010
• Start date: March 2009

Study information

• Verified date: April 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Able to provide consent/assent

• History of spring/summer allergic rhinitis

• Positive skin prick and/or intradermal test

• Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations

• Non-pregnant (where applicable)

• Able to complete daily diary

Exclusion Criteria:

• Smoker

• Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps

• History of current chronic sinusitis

• Asthma

• Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines

• History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses

• History or evidence of nasolacrimal drainage system malfunction

Study Design

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Olopatadine HCl Nasal Spray, 0.6%
2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days
• Azelastine HCl Nasal Spray, 0.1%
2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline	Responses to patient-completed diaries for reflective Total Nasal Symptom Scores (rTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Reflective scores were assessed from the hour since the last dose of study medication.	14 days minus baseline	No
Primary	Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline	Responses to patient-completed diaries for reflective Total Ocular Symptom Scores (rTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Reflective scores were assessed from the hour since the last dose of study medication.	14 days minus baseline	No
Primary	Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline	Responses to patient-completed diaries for instantaneous Total Nasal Symptom Scores (iTNSS). TNSS is composed of 4 individual assessments, which included runny nose, itchy nose, stuffy nose, and sneezing; each of the 4 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 4 assessments are then added together for a composite score (TNSS score), the maximum of which could be 12 . Instantaneous scores were assessed at the time of daily dosing.	14 days minus baseline	No
Primary	Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline	Responses to patient-completed diaries for instantaneous Total Ocular Symptom Scores (iTOSS). TOSS is composed of 3 individual assessments of ocular symptoms (itching/burning, tearing/watering, redness) each of the 3 assessments were rated using a 4 point scale that ranged in whole units from 0 (none) to 3 (severe). All 3 assessments are then added together for a composite score (TOSS score), the maximum of which could be 9 . Instantaneous scores were assessed at the time of daily dosing.	14 days minus baseline	No