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An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo

Primary Purpose

Allergic Rhinitis

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Fluticasone Furoate Nasal Spray

Olopatadine Nasal Spray

Saline Nasal Spray

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2;
known intolerance or allergy to antihistamines or corticosteroids;
have a compromised lung function at 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 planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter;
use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Olopatadine Nasal Spray (Patanase)

Fluticasone Furoate Nasal Spray (Veramyst)

Saline Nasal Spray (Placebo)

Arm Description

Outcomes

Primary Outcome Measures

Nasal Signs and Symptoms (TNSS)

TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion.

Secondary Outcome Measures

Peak Expiratory Flow Rate (PEFR)

Peak Nasal Inspiratory Flow (PNIF)

Headaches

Full Information

NCT ID

NCT01076439

First Posted

February 24, 2010

Last Updated

February 21, 2012

Sponsor

ORA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01076439

Brief Title

An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo

Official Title

A Pilot Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo Nasal Spray in Reducing Nasal Allergic Symptoms Following Ragweed Exposure in the Allergen BioCube (ABC)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Withdrawn

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ORA, Inc.

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the onset of action of fluticasone furoate nasal spray compared to olopatadine nasal spray and placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the Allergen BioCube (ABC) after single dose administration and six consecutive days of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olopatadine Nasal Spray (Patanase)

Arm Type

Active Comparator

Arm Title

Fluticasone Furoate Nasal Spray (Veramyst)

Arm Type

Active Comparator

Arm Title

Saline Nasal Spray (Placebo)

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Fluticasone Furoate Nasal Spray

Intervention Description

Fluticasone Furoate Nasal Spray: 110mcg QD

Intervention Type

Drug

Intervention Name(s)

Olopatadine Nasal Spray

Intervention Description

Olopatadine Nasal Spray: 2660mcg BID

Intervention Type

Drug

Intervention Name(s)

Saline Nasal Spray

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Nasal Signs and Symptoms (TNSS)

Description

TNSS (0-12 unit scale) is defined as the sum of the four nasal symptom scores recorded for nasal itching, sneezing, rhinorrhea and nasal congestion.

Time Frame

Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure

Secondary Outcome Measure Information:

Title

Peak Expiratory Flow Rate (PEFR)

Time Frame

Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure

Title

Peak Nasal Inspiratory Flow (PNIF)

Time Frame

Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure

Title

Headaches

Time Frame

Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: manifest symptoms of clinically active allergic rhinitis at the start of Visit 1 or Visit 2; known intolerance or allergy to antihistamines or corticosteroids; have a compromised lung function at 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 planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter; use disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies including prescription, over the counter or homeopathy, and over the counter sleeping aids) during the study or appropriate pre-study washout period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. J. Crampton, MD

Organizational Affiliation

ORA, Inc.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

An Allergen BioCube (ABC) Study Evaluating the Onset of Action of Fluticasone Furoate Nasal Spray and Olopatadine Nasal Spray Compared to Placebo

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