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

NCT01439815 | Completed Phase 4 Results DMC

• 1 other identifier: 11-100-0007
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis; Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Placebo Nasal Spray

PLACEBO COMPARATOR

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

Fluticasone Propionate

ACTIVE COMPARATOR

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

Interventions

Fluticasone Propionate Nasal Spray DRUG

two sprays in each nostril once daily

Also known as: Flonase

Fluticasone Propionate

Saline Nasal Spray DRUG

two sprays in each nostril once daily

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ORA, Inc.: lead

Study Sites (1)

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Caitlin Pearson
• Organization: Ora

cpearson@oraclinical.com

978-685-8900

Study Officials

• Tarek Shazly, MD

  ORA, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 23, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 14, 2021
• Results First Posted: March 24, 2021

Record last verified: 2020-11

Locations

US (1)