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

NCT ID: NCT01439815

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-10-31

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.

Conditions

Allergic Rhinitis; Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo Nasal Spray

Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.

Group Type: PLACEBO_COMPARATOR

Saline Nasal Spray

Intervention Type: DRUG

two sprays in each nostril once daily

Fluticasone Propionate

Two sprays in each nostril daily starting the day in office on Day 0 for up to a 17 day period until Day 16.

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate Nasal Spray

Intervention Type: DRUG

two sprays in each nostril once daily

Interventions

Fluticasone Propionate Nasal Spray

two sprays in each nostril once daily

Intervention Type: DRUG

Saline Nasal Spray

two sprays in each nostril once daily

Intervention Type: DRUG

Other Intervention Names

Flonase

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

• 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

Tarek Shazly, MD

Role: PRINCIPAL_INVESTIGATOR

ORA, Inc.

Locations

Ora, Inc.

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

11-100-0007

Identifier Type: -

Identifier Source: org_study_id