An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Allergic Conjunctivitis
• Intervention / Treatment: Drug: Saline Nasal Spray; Drug: Fluticasone Propionate Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • ORA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;
• use disallowed medications during the study or appropriate pre-study washout period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Saline Nasal Spray; two sprays in each nostril once daily
Active Comparator: 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.	Drug: Fluticasone Propionate Nasal Spray; two sprays in each nostril once daily; Other Names: Flonase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (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.	pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16	Nasal Itching was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal itching score between Day 0 and Day 16 was analyzed.	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	Sneezing was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average sneezing score between Day 0 and Day 16 was analyzed.	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	Rhinorrhea was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average rhinorrhea score between Day 0 and Day 16 was analyzed.	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	Nasal Congestion was assessed by the participants pre-ABC exposure and approximately every 15 minutes while in the ABC on Day 0 and Day 16 on a 0-4 scale (0 = none to 4 = severe). The change in average nasal congestion score between Day 0 and Day 16 was analyzed.	pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16

Collaborators and Investigators

• Sponsor: ORA, Inc.
• Investigators: Principal Investigator: Tarek Shazly, MD, ORA, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 22, 2011
• First Posted (Estimate): September 23, 2011

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: 11-100-0007