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

Phase 4

Completed

• Conditions: Allergic Rhinitis; Allergic Conjunctivitis
• Interventions: Drug: Fluticasone Propionate Nasal Spray; Drug: Saline Nasal Spray

• Registration Number: NCT01439815
• Lead Sponsor: ORA, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2020-08-19
• Status Verified: 2020-11
• Results First Submitted QC: 2021-03-23
• Results First Posted: 2021-03-24
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone Propionate	Fluticasone Propionate 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.
Placebo Nasal Spray	Saline 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.

Primary Outcome Measures

Name	Time	Method
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)	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 Outcome Measures

Name	Time	Method
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	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.
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	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.
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	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.
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	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.

Trial Locations

Locations (1)

Ora, Inc.; 🇺🇸 Andover, Massachusetts, United States