Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS

Seasonal Allergic Rhinitis Clinical Trial

Official title:

R, DB, PC, AC, One-Week, Cross-Over, MC Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg FFNS and 200mcg FPNS in Adult Subjects With SAR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539006
• Other study ID #: FFU105924
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2007
• Last updated: December 15, 2011
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: December 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• FPNS
fluticasone propionate nasal spray
• FFNS
fluticasone furoate nasal spray
• placebo FPNS
placebo nasal spray matching fluticasone propionate nasal spray
• placebo FFNS
placebo nasal spray matching fluticasone furoate nasal spray

Locations

Country	Name	City	State
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Brick	New Jersey
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	El Paso	Texas
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Johnson City	Tennessee
United States	GSK Investigational Site	Kerrville	Texas
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	North Andover	Massachusetts
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Scottsdale	Arizona
United States	GSK Investigational Site	Skillman	New Jersey
United States	GSK Investigational Site	South Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)	No
Primary	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."	End of Crossover Period (Day 22)	No
Secondary	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."	End of Crossover Period (Day 22)	No
Secondary	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."	End of Crossover Period (Day 22)	No
Secondary	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	End of Crossover Period (Day 22)	No
Secondary	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.	Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)	No
Secondary	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.	Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)	No