Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS

Completed · Phase 4 · Has a placebo group

Conditions studied: Rhinitis, Allergic, Perennial

In brief

The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.

Key facts

Study ID

NCT00519636

Run by

GlaxoSmithKline

People needed

360

Starts

2007-08-01

Expected to finish

2007-11-01

Last updated by the study team

2016-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — Vista, California, United States
• GSK Investigational Site — Tallahassee, Florida, United States
• GSK Investigational Site — Lilburn, Georgia, United States
• GSK Investigational Site — Bangor, Maine, United States
• GSK Investigational Site — Bethesda, Maryland, United States
• GSK Investigational Site — Ocean City, New Jersey, United States
• GSK Investigational Site — Ithaca, New York, United States
• GSK Investigational Site — Rockville Centre, New York, United States
• GSK Investigational Site — Collegeville, Pennsylvania, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Charleston, South Carolina, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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