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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00845195
First received: February 13, 2009
Last updated: April 22, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: Olopatadine HCl Nasal Spray, 0.6%
Drug: Azelastine HCl Nasal Spray, 0.1%
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline [ Time Frame: 14 days minus baseline ] [ Designated as safety issue: No ]
    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.

  • Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline [ Time Frame: 14 days minus baseline ] [ Designated as safety issue: No ]
    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.

  • Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline [ Time Frame: 14 days minus baseline ] [ Designated as safety issue: No ]
    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.

  • Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline [ Time Frame: 14 days minus baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: March 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olopatadine HCl Nasal Spray, 0.6% 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
Active Comparator: Azelastine HCl Nasal Spray, 0.1% Drug: 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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845195

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Michael Edwards, PhD\Global Medical Affairs- Allergy, Alcon Research
ClinicalTrials.gov Identifier: NCT00845195     History of Changes
Other Study ID Numbers: SMA-08-23
Study First Received: February 13, 2009
Results First Received: March 25, 2010
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Rhinitis
Allergy
Nasal Spray
Antihistamine
Intranasal Corticosteroid

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Histamine Antagonists
Azelastine
Olopatadine
Histamine H1 Antagonists
Histamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on May 23, 2013