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Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FPNS
FFNS
placebo FPNS
placebo FFNS
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring fluticasone propionate, seasonal allergic rhinitis, fluticasone furoate, experience, GW685698X, preference

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

FFNS, FPNS

FPNS, FFNS

placebo FFNS, placebo FPNS

placebo FPNS, placebo FFNS

Arm Description

active compound

active compound

placebo arm

placebo arm

Outcomes

Primary Outcome Measures

Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
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.
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
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."

Secondary Outcome Measures

Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
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."
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
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."
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods
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
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.
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
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.

Full Information

First Posted
October 2, 2007
Last Updated
October 27, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00539006
Brief Title
Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
fluticasone propionate, seasonal allergic rhinitis, fluticasone furoate, experience, GW685698X, preference

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FFNS, FPNS
Arm Type
Active Comparator
Arm Description
active compound
Arm Title
FPNS, FFNS
Arm Type
Active Comparator
Arm Description
active compound
Arm Title
placebo FFNS, placebo FPNS
Arm Type
Placebo Comparator
Arm Description
placebo arm
Arm Title
placebo FPNS, placebo FFNS
Arm Type
Placebo Comparator
Arm Description
placebo arm
Intervention Type
Drug
Intervention Name(s)
FPNS
Other Intervention Name(s)
fluticasone propionate, fluticasone furoate
Intervention Description
fluticasone propionate nasal spray
Intervention Type
Drug
Intervention Name(s)
FFNS
Intervention Description
fluticasone furoate nasal spray
Intervention Type
Drug
Intervention Name(s)
placebo FPNS
Intervention Description
placebo nasal spray matching fluticasone propionate nasal spray
Intervention Type
Drug
Intervention Name(s)
placebo FFNS
Intervention Description
placebo nasal spray matching fluticasone furoate nasal spray
Primary Outcome Measure Information:
Title
Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Description
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.
Time Frame
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Title
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Description
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."
Time Frame
End of Crossover Period (Day 22)
Secondary Outcome Measure Information:
Title
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Description
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."
Time Frame
End of Crossover Period (Day 22)
Title
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
Description
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."
Time Frame
End of Crossover Period (Day 22)
Title
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Description
Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods
Time Frame
End of Crossover Period (Day 22)
Title
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
Description
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.
Time Frame
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Title
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
Description
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.
Time Frame
Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
GSK Investigational Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
GSK Investigational Site
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
Facility Name
GSK Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
GSK Investigational Site
City
Brick
State/Province
New Jersey
ZIP/Postal Code
8724
Country
United States
Facility Name
GSK Investigational Site
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
GSK Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
GSK Investigational Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
GSK Investigational Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
GSK Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
GSK Investigational Site
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
20408344
Citation
Meltzer EO, Andrews C, Journeay GE, Lim J, Prillaman BA, Garris C, Philpot E. Comparison of patient preference for sensory attributes of fluticasone furoate or fluticasone propionate in adults with seasonal allergic rhinitis: a randomized, placebo-controlled, double-blind study. Ann Allergy Asthma Immunol. 2010 Apr;104(4):331-8. doi: 10.1016/j.anai.2010.02.010.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFU105924
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFU105924
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFU105924
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFU105924
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFU105924
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFU105924
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
FFU105924
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS

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