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

NCT01076439 | Withdrawn Phase 4

• 1 other identifier: 10-270-0006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Peak Expiratory Flow Rate (PEFR)

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

• Peak Nasal Inspiratory Flow (PNIF)

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

• Headaches

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

Study Arms (3)

Olopatadine Nasal Spray (Patanase)

ACTIVE COMPARATOR

Drug: Olopatadine Nasal Spray

Fluticasone Furoate Nasal Spray (Veramyst)

ACTIVE COMPARATOR

Drug: Fluticasone Furoate Nasal Spray

Saline Nasal Spray (Placebo)

PLACEBO COMPARATOR

Drug: Saline Nasal Spray

Interventions

Fluticasone Furoate Nasal Spray DRUG

Fluticasone Furoate Nasal Spray: 110mcg QD

Fluticasone Furoate Nasal Spray (Veramyst)

Olopatadine Nasal Spray DRUG

Olopatadine Nasal Spray: 2660mcg BID

Olopatadine Nasal Spray (Patanase)

Saline Nasal Spray DRUG

Placebo

Saline Nasal Spray (Placebo)

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:

• 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

Sponsors & Collaborators

• ORA, Inc.: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• H. J. Crampton, MD

  ORA, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Last Updated: February 22, 2012

Record last verified: 2012-02