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

Condition(s) targeted: Perennial Allergic Rhinitis (PAR)

Intervention: fluticasone furoate nasal spray (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

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

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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.

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: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study

Primary outcome:

Ocular safety outcome measures over a 104 week treatment period

Time to first occurrence of an event for LOCS III posterior subcapsular opacity (P). An event for P is defined as an increase of 0.3 or greater from baseline in LOCS III grade for P, in either eye.

Time to first occurrence of an event for intraocular pressure (IOP). An event for IOP is defined as an increase of 7mm Hg or greater from baseline in intraocular pressure, in either eye, using Goldmann Applanation Tonometry.

Secondary outcome:

Ocular and other safety outcome measures over a 104 week treatment period

Change from baseline in LogMAR (Logarithm of the Minimum Angle of Resolution) visual acuity using Early Treatment Diabetic Retinopathy Study (ETDRS) charts

Change from baseline in IOP

Change from baseline in horizontal cup-to-disc ratio

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:

1. 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.

2. Outpatient

•Subject is treatable on an outpatient basis.

3. Age

•12 years of age and older at Visit 2

4. 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.

5. 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.

6. 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.

7. Ability to comply with study procedures Subject understands and is willing, able and likely to comply with study procedures and restrictions.

8. 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:

1. 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

2. 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.

3. 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)

4. Use of immunosuppressive medications 8 weeks prior to screening and during the study

5. 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.

6. Use of any medications that significantly alter the pharmacokinetics of fluticasone furoate (ritonavir and ketoconazole)

7. Use of chronic treatment with agents known to promote the development of cataracts (e. g., potassium-sparing diuretics and allopurinol)

8. Allergy/Intolerance

•Known hypersensitivity to corticosteroids or any excipients

9. 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

10. Positive urine pregnancy test or female who is breastfeeding

•Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2

11. 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.

12. 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

13. 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.

14. Findings of a clinically significant, abnormal ECG

15. Findings of a clinically significant laboratory abnormality

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Oxford, Alabama 36203, United States; Recruiting

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

GSK Investigational Site, Long Beach, California 90806, United States; Withdrawn

GSK Investigational Site, Los Angeles, California 90027, United States; Withdrawn

GSK Investigational Site, Los Angeles, California 90033, United States; Withdrawn

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

GSK Investigational Site, Beverly Hills, California 90212, United States; Withdrawn

GSK Investigational Site, Orange, California 92868, United States; Withdrawn

GSK Investigational Site, Camarillo, California 93010, United States; Withdrawn

GSK Investigational Site, Santa Barbara, California 93102, United States; Withdrawn

GSK Investigational Site, Long Beach, California 90808, United States; Withdrawn

GSK Investigational Site, Granada Hills, California 91344, United States; Withdrawn

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

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

GSK Investigational Site, Sacramento, California 95823, United States; Active, not recruiting

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

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

GSK Investigational Site, Rolling Hills Estates, California 90274, United States; Active, not recruiting

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

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

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

GSK Investigational Site, Vista, California 92083, United States; Recruiting

GSK Investigational Site, Fresno, California 93720, United States; Recruiting

GSK Investigational Site, Stockton, California 95207, United States; Recruiting

GSK Investigational Site, Roseville, California 95678, United States; Recruiting

GSK Investigational Site, Loveland, Colorado 80538, United States; Withdrawn

GSK Investigational Site, Denver, Colorado 80206, United States; Withdrawn

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

GSK Investigational Site, Centennial, Colorado 80033, United States; Withdrawn

GSK Investigational Site, Colorado Springs, Colorado 80905, United States; Withdrawn

GSK Investigational Site, Englewood, Colorado 80112, United States; Recruiting

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

GSK Investigational Site, Denver, Colorado 80230, United States; Recruiting

GSK Investigational Site, Hartford, Connecticut 06106, United States; Withdrawn

GSK Investigational Site, Jacksonville, Florida 32216, United States; Withdrawn

GSK Investigational Site, Jacksonville, Florida 32207, United States; Withdrawn

GSK Investigational Site, Valrico, Florida 33594, United States; Withdrawn

GSK Investigational Site, Bay Pines, Florida 33744, United States; Withdrawn

GSK Investigational Site, Tampa, Florida 33613, United States; Withdrawn

GSK Investigational Site, Miami, Florida 33176, United States; Withdrawn

GSK Investigational Site, Tallahassee, Florida 32308, United States; Recruiting

GSK Investigational Site, Conyers, Georgia 30013, United States; Recruiting

GSK Investigational Site, Stockbridge, Georgia 30281, United States; Recruiting

GSK Investigational Site, Woodstock, Georgia 30188, United States; Withdrawn

GSK Investigational Site, Columbus, Georgia 31904, United States; Withdrawn

GSK Investigational Site, Gainesville, Georgia 30501, United States; Recruiting

GSK Investigational Site, Lawrenceville, Georgia 30045, United States; Recruiting

GSK Investigational Site, Decatur, Illinois 62526, United States; Withdrawn

GSK Investigational Site, Evansville, Indiana 47713, United States; Withdrawn

GSK Investigational Site, South Bend, Indiana 46617, United States; Active, not recruiting

GSK Investigational Site, Indianapolis, Indiana 46208, United States; Recruiting

GSK Investigational Site, Iowa City, Iowa 49342, United States; Withdrawn

GSK Investigational Site, Lexington, Kentucky 40536, United States; Withdrawn

GSK Investigational Site, Louisville, Kentucky 40215, United States; Withdrawn

GSK Investigational Site, Baltimore, Maryland 21236, United States; Withdrawn

GSK Investigational Site, Bethesda, Maryland 20814, United States; Recruiting

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

GSK Investigational Site, Boston, Massachusetts 02114, United States; Withdrawn

GSK Investigational Site, Minneapolis, Minnesota 55416, United States; Withdrawn

GSK Investigational Site, Rochester, Minnesota 55905, United States; Withdrawn

GSK Investigational Site, Minneapolis, Minnesota 55402, United States; Recruiting

GSK Investigational Site, Rolla, Missouri 65401, United States; Withdrawn

GSK Investigational Site, Columbia, Missouri 65203, United States; Withdrawn

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

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

GSK Investigational Site, Warrensburg, Missouri 64093, United States; Withdrawn

GSK Investigational Site, Billings, Montana 59101, United States; Withdrawn

GSK Investigational Site, Bozeman, Montana 59718, United States; Recruiting

GSK Investigational Site, Papillion, Nebraska 68046, United States; Recruiting

GSK Investigational Site, Lincoln, Nebraska 68505, United States; Withdrawn

GSK Investigational Site, Omaha, Nebraska 68130-2325, United States; Withdrawn

GSK Investigational Site, Omaha, Nebraska 68130, United States; Recruiting

GSK Investigational Site, Omaha, Nebraska 68131, United States; Recruiting

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

GSK Investigational Site, Summit, New Jersey 07091, United States; Withdrawn

GSK Investigational Site, Teaneck, New Jersey 07666, United States; Withdrawn

GSK Investigational Site, Brick, New Jersey 8724, United States; Withdrawn

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

GSK Investigational Site, Bronx, New York 10461, United States; Withdrawn

GSK Investigational Site, Rockville Center, New York 11570, United States; Withdrawn

GSK Investigational Site, Raleigh, North Carolina 27612, United States; Withdrawn

GSK Investigational Site, Charlotte, North Carolina 28262, United States; Withdrawn

GSK Investigational Site, Durham, North Carolina 27704, United States; Withdrawn

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

GSK Investigational Site, High Point, North Carolina 27262, United States; Withdrawn

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

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

GSK Investigational Site, Sylvania, Ohio 43560, United States; Recruiting

GSK Investigational Site, Centerville, Ohio 45458, United States; Withdrawn

GSK Investigational Site, Cincinnati, Ohio 45231, United States; Recruiting

GSK Investigational Site, Canton, Ohio 44718, United States; Recruiting

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

GSK Investigational Site, Tulsa, Oklahoma 74133, United States; Withdrawn

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

GSK Investigational Site, Portland, Oregon 97213, United States; Recruiting

GSK Investigational Site, Lake Oswego, Oregon 97035, United States; Withdrawn

GSK Investigational Site, Medford, Oregon 97504, United States; Withdrawn

GSK Investigational Site, Eugene, Oregon 97404, United States; Withdrawn

GSK Investigational Site, Eugene, Oregon 97401, United States; Recruiting

GSK Investigational Site, Annville, Pennsylvania 17078, United States; Withdrawn

GSK Investigational Site, Philadelphia, Pennsylvania 19107, United States; Withdrawn

GSK Investigational Site, Charleston, South Carolina 29407, United States; Withdrawn

GSK Investigational Site, Columbia, South Carolina 29201, United States; Withdrawn

GSK Investigational Site, Spartanburg, South Carolina 29303, United States; Withdrawn

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

GSK Investigational Site, Nashville, Tennessee 37208, United States; Withdrawn

GSK Investigational Site, Knoxville, Tennessee 37909, United States; Withdrawn

GSK Investigational Site, San Antonio, Texas 78229, United States; Active, not recruiting

GSK Investigational Site, Kerrville, Texas 78028, United States; Active, not recruiting

GSK Investigational Site, Austin, Texas 78750, United States; Active, not recruiting

GSK Investigational Site, El Paso, Texas 79925, United States; Withdrawn

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

GSK Investigational Site, Dallas, Texas 75231, United States; Withdrawn

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

GSK Investigational Site, Waco, Texas 76712, United States; Active, not recruiting

GSK Investigational Site, Dallas, Texas, United States; Active, not recruiting

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

GSK Investigational Site, Kirkland, Washington 98034, United States; Withdrawn

GSK Investigational Site, Spokane, Washington 99204, United States; Recruiting

GSK Investigational Site, Seattle, Washington 98105, United States; Withdrawn

GSK Investigational Site, Madison, Wisconsin 53792, United States; Withdrawn

GSK Investigational Site, Greenfield, Wisconsin 53228, United States; Recruiting

Starting date: June 2008
Ending date: April 2011
Last updated: February 12, 2009