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

NCT ID: NCT01076439

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Olopatadine Nasal Spray (Patanase)

Group Type: ACTIVE_COMPARATOR

Olopatadine Nasal Spray

Intervention Type: DRUG

Olopatadine Nasal Spray: 2660mcg BID

Fluticasone Furoate Nasal Spray (Veramyst)

Group Type: ACTIVE_COMPARATOR

Fluticasone Furoate Nasal Spray

Intervention Type: DRUG

Fluticasone Furoate Nasal Spray: 110mcg QD

Saline Nasal Spray (Placebo)

Group Type: PLACEBO_COMPARATOR

Saline Nasal Spray

Intervention Type: DRUG

Placebo

Interventions

Fluticasone Furoate Nasal Spray

Fluticasone Furoate Nasal Spray: 110mcg QD

Intervention Type: DRUG

Olopatadine Nasal Spray

Olopatadine Nasal Spray: 2660mcg BID

Intervention Type: DRUG

Saline Nasal Spray

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H. J. Crampton, MD

Role: PRINCIPAL_INVESTIGATOR

ORA, Inc.

Other Identifiers

10-270-0006

Identifier Type: -

Identifier Source: org_study_id