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A Clinical Study With Fluticasone Furoate Nasal Spray And Vehicle Placebo For The Treatment Of Perennial (Year-round) Allergic Rhinitis

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Perennial

Intervention: fluticasone furoate nasal spray (Drug); vehicle placebo nasal spray (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two-Year Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray 110mcg in Adults and Adolescents 12 Years of Age and Older With Perennial Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Cumulative Proportion (CU) of Participants (Par.) With an Event, as Measured as a Percentage, for Posterior Subcapsular Opacity (P)

Cumulative Proportion of Participants, as Measured as a Percentage, With an Intraocular Pressure (IOP) Event

Secondary outcome:

Change From Baseline in LOCS III Posterior Subcapsular Opacity at Week 52 and Week 104

Number of Participants With the Indicated Change From Baseline in LOCS III Posterior Subcapsular Opacity by Increments of 0.1 at Weeks 52 and 104

Change From Baseline in LOCS III Cortical Opacity (C) at Week 52 and Week 104

Number of Participants With the Indicated Change From Baseline in Cortical Opacity by Increment Categories of >=0.3, >=0.5, and >=1.0 at Weeks 52 and 104

Change From Baseline in LOCS III Nuclear Opacity (NO) at Week 52 and Week 104

Change From Baseline in Nuclear Color (NC) at Week 52 and Week 104

Change From Baseline in Intraocular Pressure (IOP) at Weeks 52 and 104

Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 52

Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) by Increments of 1 mm Hg at Week 104

Change From Baseline in Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts at Week 52 and Week 104

Percent Change From Baseline in the Funduscopic Horizontal Cup-to-disc Ratio at Week 104

Change From Baseline in the Daily Reflective Total Nasal Symptom Score (rTNSS) for the Indicated Study Periods

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Subjects eligible for enrollment in the study must meet all of the following criteria:

- Informed consent

- Subject has provided an appropriately signed and dated informed consent. An

appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.

- Outpatient

- Subject is treatable on an outpatient basis.

- Age

- 12 years of age and older at Visit 2

- Male or eligible female Female subjects should not be enrolled if they plan to

become pregnant during the time of study participation. 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, or

- Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps)

plus Spermicide,

- Estrogenic vaginal ring. A urine pregnancy test will be done at the screening visit

to confirm females of childbearing potential are not pregnant upon entry into the study. In addition, urine pregnancy tests will be done for all females of childbearing potential at each clinic visit.

- Diagnosis of PAR to include:

A positive skin test (by prick method) response to appropriate perennial allergen (house dust mites, animal dander, mold, or cockroach) within last 12 months prior to Visit 1 or at Visit 1. A positive skin test is defined as a wheal ³3mm larger than the diluent control for prick testing. •Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i. e., year-round, symptoms. PAR symptoms could include nasal congestion, rhinorrhea, nasal itching and sneezing. In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR. NOTE: Subjects who meet the above criteria and who also may have seasonal allergic rhinitis (SAR) and/or perennial non-allergic rhinitis (PNAR) are eligible for randomization.

- Environment

•Subject must be symptomatic to appropriate perennial allergen (animal dander, house dust mites, cockroach, mold) and willing to maintain, as much as possible, the same environment throughout the study.

- 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: Subjects meeting any of the following criteria must not be enrolled in the study:

- 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.

- History or current diagnosis of diabetes mellitus

- Uncontrolled hypertension (i. e., systolic blood pressure ³ 140mm Hg or diastolic

blood pressure ³ 90mm Hg)

- A severe physical obstruction of the nose (e. g., deviated septum or nasal polyp)

or nasal septal perforation that could affect the deposition of double blind intranasal study drug

- Nasal (e. g., nasal septum) or ocular injury/surgery in the last 6 months

(including LASIK eye surgery)

- Asthma, with the exception of mild intermittent asthma [National Asthma

Education and Prevention Program (NAEPP) Guidelines for the Diagnosis and

Management of Asthma - Expert Panel Report 3, National Institutes of Health,

August 28, 2007. NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.

- 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 ocular herpes simplex

- Current cataract and/or previous history of cataract surgery

- 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 Hepatitis B or C

- Use of corticosteroids, defined as:

- Intranasal corticosteroid within 4 weeks prior to Visit 1 (e. g., VERAMYST, FLONASE™,

Nasonex, Rhinocort).

- Inhaled, oral, intramuscular, intravenous, ocular, and/or topical corticosteroids

(with the exception of topical hydrocortisone, 1% or less, or equivalent) within 8 weeks prior to Visit 1.

- Use of other allergy medications within the timeframe indicated relative to

Visit 1

- Intranasal or ocular cromolyn within 14 days prior to Visit 1 (e. g., Nasalcrom,

Crolom)

- Short-acting prescription and non-prescription antihistamines, including ocular

preparations and antihistamines contained in insomnia and "night time" pain formulations, within 3 days prior to Visit 1 (e. g., Benadryl, Chlortrimeton, Dimetane, Tavist)

- Long-acting antihistamines within 10 days prior to Visit 1 (e. g., Allegra, Claritin,

Clarinex, Zyrtec).

- Intranasal antihistamines (e. g., Astelin) within 2 weeks prior to Visit 1

- Oral or intranasal decongestants within 3 days prior to Visit 1 (e. g., Sudafed)

- Long-acting beta-agonists within 3 days prior to Visit 1 (e. g., SEREVENT™, Foradil)

- Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1 (e. g.,

Atrovent)

- Oral antileukotrienes within 3 days of Visit 1 (e. g., Singulair)

- Subcutaneous omalizumab (Xolair) within 5 months of 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

- Use of other intranasally administered medications (e. g., Miacalcin)

- Use of immunosuppressive medications 8 weeks prior to screening and during the

study

- Immunotherapy Immunotherapy patients may be enrolled in 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.

- Use of any medications that significantly alter the pharmacokinetics of

fluticasone furoate (ritonavir and ketoconazole)

- Use of chronic treatment with agents known to promote the development of

cataracts (e. g., potassium-sparing diuretics and allopurinol)

- Allergy/Intolerance

- Known hypersensitivity to corticosteroids or any excipients

- 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 FFNS (GW685698X) clinical study

- Positive urine 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.

- Tobacco use

- Subject currently uses smoking products including cigarettes, cigars, and pipe or

chewing tobacco, or has used these products in the last 6 months

- 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 three 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.

- Findings of a clinically significant, abnormal ECG

- Findings of a clinically significant laboratory abnormality

Locations and Contacts

GSK Investigational Site, Oxford, Alabama 36203, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Fresno, California 93720, United States

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, Los Angeles, California 90025, United States

GSK Investigational Site, Mission Viejo, California 92691, United States

GSK Investigational Site, Rolling Hills Estates, California 90274, United States

GSK Investigational Site, Roseville, California 95678, United States

GSK Investigational Site, Sacramento, California 95823, United States

GSK Investigational Site, San Diego, California 92120, United States

GSK Investigational Site, San Diego, California 92123, United States

GSK Investigational Site, San Jose, California 95117, United States

GSK Investigational Site, Stockton, California 95207, United States

GSK Investigational Site, Vista, California 92083, United States

GSK Investigational Site, Walnut Creek, California 94598, United States

GSK Investigational Site, Colorado Springs, Colorado 80907, United States

GSK Investigational Site, Denver, Colorado 80230, United States

GSK Investigational Site, Englewood, Colorado 80112, United States

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States

GSK Investigational Site, Tallahassee, Florida 32308, United States

GSK Investigational Site, Conyers, Georgia 30013, United States

GSK Investigational Site, Gainesville, Georgia 30501, United States

GSK Investigational Site, Lawrenceville, Georgia 30045, United States

GSK Investigational Site, Stockbridge, Georgia 30281, United States

GSK Investigational Site, Indianapolis, Indiana 46208, United States

GSK Investigational Site, South Bend, Indiana 46617, United States

GSK Investigational Site, Bethesda, Maryland 20814, United States

GSK Investigational Site, North Dartmouth, Massachusetts 02747, United States

GSK Investigational Site, Minneapolis, Minnesota 55402, United States

GSK Investigational Site, St. Louis, Missouri 63141, United States

GSK Investigational Site, Bozeman, Montana 59718, United States

GSK Investigational Site, Bellevue, Nebraska 68123-4303, United States

GSK Investigational Site, Omaha, Nebraska 68131, United States

GSK Investigational Site, Omaha, Nebraska 68130, United States

GSK Investigational Site, Ocean, New Jersey 07712, United States

GSK Investigational Site, Skillman, New Jersey 08558, United States

GSK Investigational Site, Asheville, North Carolina 28801, United States

GSK Investigational Site, Raleigh, North Carolina 27607, United States

GSK Investigational Site, Canton, Ohio 44718, United States

GSK Investigational Site, Cincinnati, Ohio 45231, United States

GSK Investigational Site, Sylvania, Ohio 43560, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73104, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73120, United States

GSK Investigational Site, Eugene, Oregon 97401, United States

GSK Investigational Site, Portland, Oregon 97213, United States

GSK Investigational Site, Summerville, South Carolina 29485, United States

GSK Investigational Site, Austin, Texas 78750, United States

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Dallas, Texas 75231-4307, United States

GSK Investigational Site, El Paso, Texas 79903, United States

GSK Investigational Site, Kerrville, Texas 78028, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Waco, Texas 76712, United States

GSK Investigational Site, South Burlington, Vermont 05403, United States

GSK Investigational Site, Spokane, Washington 99204, United States

GSK Investigational Site, Greenfield, Wisconsin 53228, United States

Additional Information

Related publications:

LaForce C, Journeay GE, Miller SD, Silvey MJ, Wu W, Lee LA, Chylack LT Jr. Ocular safety of fluticasone furoate nasal spray in patients with perennial allergic rhinitis: a 2-year study. Ann Allergy Asthma Immunol. 2013 Jul;111(1):45-50. doi: 10.1016/j.anai.2013.04.013. Epub 2013 May 12.

Starting date: June 2008
Last updated: August 18, 2014

Page last updated: August 23, 2015

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