Back to resultsAn Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
Primary Purpose
Allergic Rhinitis, Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluticasone Propionate Nasal Spray
Saline Nasal Spray
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Rhinitis
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;
- use disallowed medications during the study or appropriate pre-study washout period
Sites / Locations
- Ora, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo Nasal Spray
Fluticasone Propionate
Arm Description
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01439815
Brief Title
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ORA, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Conjunctivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Nasal Spray
Arm Type
Placebo Comparator
Arm Description
Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.
Arm Title
Fluticasone Propionate
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Fluticasone Propionate Nasal Spray
Other Intervention Name(s)
Flonase
Intervention Description
two sprays in each nostril once daily
Intervention Type
Drug
Intervention Name(s)
Saline Nasal Spray
Intervention Description
two sprays in each nostril once daily
Primary Outcome Measure Information:
Title
Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
Description
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.
Time Frame
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Secondary Outcome Measure Information:
Title
Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
Description
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.
Time Frame
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Title
Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
Description
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.
Time Frame
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Title
Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
Description
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.
Time Frame
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Title
Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
Description
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.
Time Frame
pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
use disallowed medications during the study or appropriate pre-study washout period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Shazly, MD
Organizational Affiliation
ORA, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
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