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

NCT ID: NCT00845195

Last Updated: 2010-04-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Olopatadine HCl Nasal Spray, 0.6%

Group Type EXPERIMENTAL

Olopatadine HCl Nasal Spray, 0.6%

Intervention Type 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%

Group Type ACTIVE_COMPARATOR

Azelastine HCl Nasal Spray, 0.1%

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon Research

Locations

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Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SMA-08-23

Identifier Type: -

Identifier Source: org_study_id

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