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

Allergic Rhinitis Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01076439
• Other study ID #: 10-270-0006
• Status: Withdrawn
• Phase: Phase 4
• First received: February 24, 2010
• Last updated: February 21, 2012

Study information

• Verified date: February 2012
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• 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:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• Fluticasone Furoate Nasal Spray
Fluticasone Furoate Nasal Spray: 110mcg QD
• Olopatadine Nasal Spray
Olopatadine Nasal Spray: 2660mcg BID
• Saline Nasal Spray
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Peak Expiratory Flow Rate (PEFR)		Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure	Yes
Secondary	Peak Nasal Inspiratory Flow (PNIF)		Measured pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure	No
Secondary	Headaches		Evaluated by the subject pre-ABC exposure, every 30 minutes during all ragweed exposures in the ABC, and post-ABC exposure	No