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

NCT00845195 | Completed Phase 4 Results

• 1 other identifier: SMA-08-23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Rhinitis; Allergy; Nasal Spray; Antihistamine; Intranasal Corticosteroid

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Olopatadine HCl Nasal Spray, 0.6%

EXPERIMENTAL

Drug: Olopatadine HCl Nasal Spray, 0.6%

Azelastine HCl Nasal Spray, 0.1%

ACTIVE COMPARATOR

Drug: Azelastine HCl Nasal Spray, 0.1%

Interventions

Olopatadine HCl Nasal Spray, 0.6% DRUG

2 sprays/nostril, twice daily (in addition to Fluticasone Propionate Nasal Spray 50 mcg 2 sprays/nostril once daily) for 14 +/- 3 days

Olopatadine HCl Nasal Spray, 0.6%

Azelastine HCl Nasal Spray, 0.1% DRUG

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%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Respiratory Tract Infections; Infections

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Research Ltd.

medinfo@alconlabs.com

888.451.3937; 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 18, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Last Updated: April 27, 2010
• Results First Posted: April 21, 2010

Record last verified: 2010-04

Locations

US (1)