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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439815
• Other study ID #: 11-100-0007
• Status: Completed
• Phase: Phase 4
• Start date: September 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2020
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Allergic Rhinitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Fluticasone Propionate Nasal Spray
two sprays in each nostril once daily
• Saline Nasal Spray
two sprays in each nostril once daily

Locations

Country	Name	City	State
United States	Ora, Inc.	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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