Clinical trial NCT01439815: An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Allergic Conjunctivitis
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


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:

* 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

Primary outcomes:
measure: Change in Total Nasal Signs and Symptoms Score From Baseline (Day 0) to Visit 5 (Day 16)
timeFrame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Secondary outcomes:
measure: Change in Baseline Nasal Itching Score on Day 0 to Average Nasal Itching Score on Day 16
timeFrame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
measure: Change in Baseline Sneezing Score on Day 0 to Average Sneezing Score on Day 16
timeFrame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
measure: Change in Baseline Rhinorrhea Score on Day 0 to Average Rhinorrhea Score on Day 16
timeFrame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
measure: Change in Baseline Nasal Congestion Score on Day 0 to Average Nasal Congestion Score on Day 16
timeFrame: pre-ABC exposure and approximately every 15 minutes, up to 180 minutes, while in the ABC on Day 0 and Day 16
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora, Inc.
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: Tarek Shazly, MD
role: PRINCIPAL_INVESTIGATOR
References: