A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of Flonase (Fluticasone Propionate Nasal Spray) Compared to Placebo Nasal Spray in the Allergen BioCube (ABC) Model

ORA, Inc.1 site in 1 country22 target enrollmentSeptember 2011

ConditionsAllergic Rhinitis Allergic Conjunctivitis

InterventionsSaline Nasal Spray Fluticasone Propionate Nasal Spray

DrugsFluticasone Propionate Nasal Spray Saline Nasal Spray

Overview

Phase: Phase 4
Intervention: Saline Nasal Spray
Conditions: Allergic Rhinitis
Sponsor: ORA, Inc.
Enrollment: 22
Locations: 1
Primary Endpoint: Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after up to 14 days of at home dosing.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

October 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ORA, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•provide written informed consent and signed HIPAA form;
•be able and willing to follow all instructions and attend the study visits;
•if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at Visit 1 and at exit visit, and to use adequate method of birth control
•have a positive history of seasonal allergic rhinitis to ragweed;
•have a positive skin test reaction to ragweed of within the past 24 months;
•manifest sufficient allergic rhinitis symptoms during ragweed exposure in the ABC

Exclusion Criteria

•known intolerance or allergy to antihistamines or corticosteroids;
•have a compromised lung function at Visit 1;
•develop a compromised lung function at Visits 2-6
•have any presence of active sinus or nasal infection at any visit;
•have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1;
•have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa)
•have had any nasal surgical intervention in the past;
•have a known history of glaucoma
•have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
•inability or refusal to discontinue contact lens wear during all visits;

Arms & Interventions

Placebo Nasal Spray

Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.

Intervention: Saline Nasal Spray

Fluticasone Propionate

Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.

Intervention: Fluticasone Propionate Nasal Spray

Outcomes

Primary Outcomes

Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)

Time Frame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16

The change in the total sum of the four symptoms (total nasal symptom scores - TNSS) ranging from 0 to 16 with higher score indicating a more severe reaction. The change in the TNSS score between Day 0 and Day 16 was analyzed.

Secondary Outcomes

Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16(pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16)