Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS

October 27, 2016 updated by: GlaxoSmithKline

A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects With Seasonal Allergic Rhinitis

The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.

Study Overview

Detailed Description

A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105924)

Study Type

Interventional

Enrollment (Actual)

377

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • GSK Investigational Site
    • California
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Huntington Beach, California, United States, 92647
        • GSK Investigational Site
      • Long Beach, California, United States, 90808
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
    • Florida
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • GSK Investigational Site
    • Massachusetts
      • North Andover, Massachusetts, United States, 01845
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • New Jersey
      • Brick, New Jersey, United States, 8724
        • GSK Investigational Site
      • Skillman, New Jersey, United States, 08558
        • GSK Investigational Site
    • New York
      • Rochester, New York, United States, 14618
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
      • Charleston, South Carolina, United States, 29414
        • GSK Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • GSK Investigational Site
      • El Paso, Texas, United States, 79902
        • GSK Investigational Site
      • Houston, Texas, United States, 77070
        • GSK Investigational Site
      • Kerrville, Texas, United States, 78028
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Subject has provided an appropriately signed and dated informed consent.
  • Otherwise healthy outpatient with fall allergy
  • Subject is treatable on an outpatient basis.
  • Age
  • 18 years or age or older at time of Visit 2
  • Male or eligible female
  • Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be required of all females at all visits to determine if the subject is pregnant.
  • To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
  • Abstinence
  • Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
  • Oral contraceptive (either combined estrogen/progestin or progestin only)
  • Injectable progestogen
  • Implants of levonorgestrel
  • Percutaneous contraceptive patches
  • Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
  • Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject
  • Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide
  • Estrogenic vaginal ring
  • Diagnosis of SAR
  • SAR is defined as follows:
  • A clinical history (written or verbal) of SAR with seasonal allergy symptoms (nasal symptoms) during each of the last two fall allergy seasons, and
  • A positive skin test (by prick method) to fall allergen prevalent to the geographic area during the conduct of the study, within 12 months prior to Visit 1 or at Visit 1.
  • A positive skin test is defined as a wheal 3 mm larger than the diluent control for prick testing.
  • In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed as a diagnosis of SAR.
  • Subjects who meet the above criteria and who may also have perennial allergic rhinitis or vasomotor rhinitis are eligible for randomization.
  • Adequate exposure to seasonal pollen
  • Subject resides within a geographical region where exposure to fall seasonal allergen is expected to be significant during the entire study period.
  • Subject does not plan to travel outside this area for more than 48 hours of the study period.
  • Ability to comply with study procedures
  • Subject understands and is willing, able and likely to comply with study procedures and restrictions.
  • Literate
  • Subject must be able to read, comprehend, and record information in English

Exclusion Criteria:

  • Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST).
  • Significant concomitant medical conditions, defined as but not limited to:
  • A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
  • A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug
  • Nasal (eg, nasal septum) injury or surgery in the last 3 months
  • Asthma, with the exception of mild intermittent asthma [National Asthma Education and Prevention Program (NARPP) Guidelines, 2002].
  • Rhinitis medicamentosa
  • Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period
  • Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
  • Current or history of glaucoma and/or cataracts or ocular herpes simplex
  • Physical impairment that would affect subject's ability to participate safely and fully in the study
  • Clinical evidence of a Candida infection of the nose
  • History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
  • History of adrenal insufficiency
  • History of shingles
  • Chickenpox or measles: A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last 3 weeks and is non-immune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease.
  • Use of other corticosteroids, defined as:
  • Intranasal corticosteroid within four weeks prior to Visit 1.
  • Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
  • Use of other allergy medications within the timeframe indicated relative to Visit 1
  • Intranasal cromolyn within 14 days prior to Visit 1
  • Short-acting prescription and OTC antihistamines, including antihistamines contained in insomnia and 'nighttime' pain formulations taken for insomnia, within 3 days prior to Visit 1
  • Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine
  • Oral or intranasal decongestants within 3 days prior to Visit 1
  • Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1
  • Oral antileukotrienes within 3 days prior to Visit 1
  • Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
  • Intranasal antihistamines (e.g. Astelin) within 2 weeks prior to Visit 1
  • Use of other medications that may affect allergic rhinitis or its symptoms
  • Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug
  • Chronic use of long-acting beta-agonists (e.g., salmeterol)
  • Chronic use of other intranasally administered medications (e.g., calcitonin-salmon)
  • Nasal irrigation solutions
  • Use of immunosuppressive medications 8 weeks prior to screening and during the study
  • Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
  • Immunotherapy
  • Subjects may be enrolled into the study if the immunotherapy was not initiated within 30 days of Visit 1, if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
  • Allergy/Intolerance
  • Known hypersensitivity to corticosteroids or any excipients in the product
  • Clinical trial/experimental medication experience
  • Has recent exposure to an investigational study drug within 30 days of Visit 1
  • Participation in a previous or current GSK FFNS study
  • Positive or inconclusive pregnancy test or female who is breastfeeding
  • Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
  • Affiliation with investigational site
  • Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
  • Current tobacco use
  • Subject currently uses smoking products including cigarettes, cigars, and pipe or chewing tobacco.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FFNS, FPNS
active compound
fluticasone propionate nasal spray
Other Names:
  • fluticasone propionate
  • fluticasone furoate
fluticasone furoate nasal spray
Active Comparator: FPNS, FFNS
active compound
fluticasone propionate nasal spray
Other Names:
  • fluticasone propionate
  • fluticasone furoate
fluticasone furoate nasal spray
Placebo Comparator: placebo FFNS, placebo FPNS
placebo arm
placebo nasal spray matching fluticasone propionate nasal spray
placebo nasal spray matching fluticasone furoate nasal spray
Placebo Comparator: placebo FPNS, placebo FFNS
placebo arm
placebo nasal spray matching fluticasone propionate nasal spray
placebo nasal spray matching fluticasone furoate nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Time Frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Time Frame: End of Crossover Period (Day 22)
Participants assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Participant could also choose "I have no preference."
End of Crossover Period (Day 22)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Time Frame: End of Crossover Period (Day 22)
Participants assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Participant could also choose "I have no preference."
End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
Time Frame: End of Crossover Period (Day 22)
Participants assessed preference over ease of use for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Participant could also choose "I have no preference."
End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Time Frame: End of Crossover Period (Day 22)
Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods
End of Crossover Period (Day 22)
Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos
Time Frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos
Time Frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (Estimate)

October 3, 2007

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: FFU105924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: FFU105924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: FFU105924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: FFU105924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: FFU105924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: FFU105924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: FFU105924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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