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

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis Allergic Conjunctivitis	Drug: Fluticasone Propionate Nasal Spray Drug: Saline Nasal Spray	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	A Single-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy of Flonase (Fluticasone Propionate Nasal Spray) Compared to Placebo Nasal Spray in the Allergen BioCube (ABC) Model

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by ORA, Inc.:

Primary Outcome Measures:

Nasal Signs and Symptoms (TNSS) [ Time Frame: approximately 3 weeks ] [ Designated as safety issue: No ]
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 at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks

Secondary Outcome Measures:

Nasal Itching [ Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks ] [ Designated as safety issue: No ]
Sneezing [ Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks ] [ Designated as safety issue: No ]
Rhinorrhea [ Time Frame: Evaluated by the subject pre-ABC exposure, every 15 minutes during all ragweed exposures in the ABC, and post-ABC exposure at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks ] [ Designated as safety issue: No ]
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 at Visits 2, 3, 4, and 5 which will occur over approximately 3 weeks ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	September 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Nasal Spray	Drug: Saline Nasal Spray two sprays in each nostril once daily
Active Comparator: Fluticasone Propionate	Drug: Fluticasone Propionate Nasal Spray 50 mcg QD Other Name: Flonase

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439815

Locations

United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

ORA, Inc.

Investigators

Principal Investigator:

Tarek Shazly, MD

ORA, Inc.

More Information

No publications provided

Responsible Party:	ORA, Inc.
ClinicalTrials.gov Identifier:	NCT01439815 History of Changes
Other Study ID Numbers:	11-100-0007
Study First Received:	September 19, 2011
Last Updated:	January 25, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

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

Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013