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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439815
First Posted: September 23, 2011
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ORA, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by ORA, Inc.:

Primary Outcome Measures:
  • Nasal Signs and Symptoms (TNSS) [ Time Frame: approximately 3 weeks ]
    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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01439815     History of Changes
Other Study ID Numbers: 11-100-0007
First Submitted: September 19, 2011
First Posted: September 23, 2011
Last Update Posted: January 26, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Conjunctivitis
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents