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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:
Information provided by (Responsible Party):
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01439815
First received: September 19, 2011
Last updated: January 25, 2012
Last verified: January 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014