This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain
clinic visits will include a physical examination, medical history review, and lung function
tests. All study related medications and medical examinations will be provided at no cost to
the subject. The drugs used in this study are approved for the age group under study.
INCLUSION CRITERIA:
A subject will be considered eligible for inclusion in this study only if all of the
following criteria apply:
- Consent: A signed and dated written informed consent must be obtained from the
subject or subject's legally acceptable representative prior to study participation.
An informed consent must be signed prior to any change in the subject's medication
regimen, including withholding medications prior to Visit 1.
- Gender: Male or female. Females are eligible to participate only if they are
currently not pregnant and not lactating. Females of child-bearing potential will be
required to use a highly effective method for avoiding pregnancy (i. e., contraception
with a failure rate of <1% per year). Female subjects of child-bearing potential will
undergo a urine pregnancy test at Visits 1, 2, 3, and 4. Any female who becomes
pregnant during the study will be withdrawn. Female subjects should not be enrolled
if they plan to become pregnant during the time of study participation.
- Age: 15 years and older.
- Asthma Diagnosis: A diagnosis of persistent asthma, for at least three months, as
defined by the following American Thoracic Society definition:
Asthma is a clinical syndrome characterized by increased responsiveness of the
tracheobronchial tree to a variety of stimuli. The major symptoms of asthma are paroxysms
of dyspnea, wheezing, and cough, which may vary from mild and almost undetectable to severe
and unremitting (status asthmaticus). The primary physiological manifestation of this
hyperresponsiveness is variable airway obstruction. This can take the form of spontaneous
fluctuations in the severity of obstruction, substantial improvements in the severity of
obstruction following bronchodilators or corticosteroids, or increased obstruction caused
by drugs or other stimuli [American Thoracic Society, 1987a].
NOTE: Intermittent and seasonal asthma, as well as exercise-induced bronchospasm alone,
are excluded.
- Asthma Therapy: 3 months' prior and current use of one of the following asthma
therapies, with no change in regimen during the month prior to Visit 1:
- Scheduled or as-needed inhaled or oral short-acting beta2-agonist (SABA).
Subjects must be able to replace their current short-acting beta2-agonist with
albuterol/salbutamol, to be used only on an as-needed basis for the duration of
the study.
- Allowed non-corticosteroid controller therapy (e. g., anticholinergics and
cromolyn).
- One of the following inhaled corticosteroids taken at the corresponding daily
dose:
criteria.
Inhaled Corticosteroid (Total Daily Dose) Beclomethasone dipropionate (≤420mcg)
Beclomethasone dipropionate HFA (≤240mcg) Budesonide (≤400mcg) Flunisolide (≤1000mcg)
Fluticasone propionate inhalation aerosol (≤220mcg) Fluticasone propionate inhalation
powder (≤250mcg) Mometasone furoate (≤220mcg) Triamcinolone acetonide (≤1000mcg) Subjects
taking ADVAIR 100/50mcg BID are eligible to replace ADVAIR with FLOVENT HFA 110mcg BID for
14 days prior to Visit 1. This change will be at the Investigator's clinical discretion,
taking each individual's current and past asthma stability into account. The subject must
be aware of the risks and benefits of switching their medication and acknowledge this by
signing an informed consent prior to any change in the subject's medication regimen.
- Asthma Severity: An FEV1 between 65% - 95% of predicted value at Visit 1 after
withholding asthma medications as detailed in the protocol.
At Visit 2, subjects must also be experiencing minimum asthma symptoms as defined in
Section 5. 2.3, "Randomization Criteria", and in Section 6. 2 of the protocol.
Predicted FEV1 will be based on the National Health and Nutrition Examination Survey
(NHANES III) predicted normal values [Hankinson, 1999].
- Rhinitis Diagnosis: A diagnosis of seasonal allergic rhinitis defined as follows:
- A clinical history (written or verbal confirmation) of allergic rhinitis with the
seasonal onset and offset of nasal allergy symptoms during each of the previous 2
relevant allergy seasons (captured in source documents only).
AND •A positive skin test reaction to a geographically relevant seasonal allergen, as
determined by the skin prick method, within 24 months prior to or at Visit 1.
For the purposes of this study, a positive skin test reaction is defined as a wheal
diameter that is at least 3mm greater than diluent control using 1: 20 W: V glycerinated
solution.
•At Visit 2, subjects must also be experiencing minimum rhinitis symptoms as defined in
Section 5. 2.3, "Randomization Criteria", and in Section 6. 2 of the protocol.
- Geographical Location: Active residence within a geographical region where exposure to
a relevant seasonal allergen is expected to be significant during the entire study
period.
Note: The principal investigator is responsible for tracking and recording pollen counts
for geographically relevant seasonal allergens throughout the entire study. Alternatively,
this information may be obtained from a reputable source from within the same geographical
area.
EXCLUSION CRITERIA:
A subject will not be eligible for inclusion in this study if any of the following criteria
apply:
- Currently Diagnosed with Life-Threatening Asthma: An episode or episodes of asthma
requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic
seizures.
- Asthma Instability: Hospitalization for asthma within 6 months of Visit 1.
- Concurrent Respiratory Disease: Current evidence of pneumonia, pneumothorax,
atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, or any other
respiratory abnormalities other than asthma.
- Nasal Obstruction: Severe physical obstruction of the nose (e. g., deviated septum)
that could affect the deposition of double-blind intranasal study drug.
- Nasal History: History of nasal septal perforation or recent nasal septal surgery.
- Other Concurrent Conditions/Diseases: Any evidence of rhinitis medicamentosa, history
of glaucoma and/or cataracts or ocular herpes simplex, or any clinically significant,
uncontrolled condition or disease state that, in the opinion of the investigator,
would put the safety of the subject at risk through study participation or would
confound the interpretation of the results if the condition/disease exacerbated during
the study.
The list of additional excluded conditions/diseases includes, but is not limited to:
cardiac arrhythmias; congestive heart failure; coronary artery disease; poorly controlled
diabetes, poorly controlled hypertension, poorly controlled peptic ulcer, hematologic,
hepatic, or renal disease; immunologic compromise; current malignancy; current or quiescent
tuberculosis, and Cushing's or Addison's disease.
- Drug Allergy: Any immediate or delayed hypersensitivity to any beta2-agonist,
sympathomimetic drug, leukotriene modifier, or any intranasal, inhaled, or systemic
corticosteroid therapy, or sensitivity to aspirin or other NSAIDS. Subjects with
severe milk protein allergies are also excluded from participation.
- Respiratory Tract Infections: Any sinus, middle ear, oropharyngeal, upper or lower
respiratory tract infection that has not resolved at least 14 days immediately
preceding Visit 1, or for which antibiotic therapy has not been completed at least 14
days prior to Visit 1.
- Concurrent Medications: Concurrent use of any of the following medications that may
affect the course of asthma, rhinitis, or interact with sympathomimetic amines or
montelukast.
- Beta-blockers
- tricyclic antidepressants
- monoamine oxidase inhibitors
- phenobarbital
- rifampin
- ritonavir
- ketoconazole
- Systemic Corticosteroids: Use of oral or parenteral systemic corticosteroids within
28 days of Visit 1, or requirement for more than two courses of parenteral systemic
corticosteroids for asthma within 6 months of Visit 1.
NOTE: Topical hydrocortisone cream or ointment (1% or less) is permitted during the
study.
- Excluded Rhinitis Medications: The following rhinitis medications must be withheld
during the corresponding "exclusion period" prior to Visit 1 and are not allowed any
time during the study, unless dispensed as double-blind study drug:
Medication (Exclusion Period Prior to Visit 1) Intranasal and ocular corticosteroids (28
days) Leukotriene modifiers (e. g., Singulair, Accolate, Zyflo) (28 days) Intranasal and
ocular cromolyn (14 days) Long-acting antihistamines (e. g., loratadine, cetirizine) (10
days) Short-acting antihistamines (includes prescription and OTC) (72 hours) Oral and
intranasal decongestants (72 hours) Intranasal anticholinergics (e. g., Atrovent) (24
hours)
- Excluded Asthma Medications: The following asthma medications must be withheld during
the corresponding "exclusion period" prior to Visit 1.
These asthma medications, with the exception of an inhaled corticosteroid/long-acting
beta2-agonist combination product and Xolair, may be continued during the run-in period of
the study (between Visits 1 and 2), but must be withheld prior to Visit 2 for the
appropriate "exclusion period" as shown below.
These asthma medications are not allowed any time after randomization at Visit 2 (with the
exception of as as-needed rescue albuterol/salbutamol), unless dispensed as double-blind
study drug:
Medicationª (Exclusion Period Prior to Visit 1 and/or Visit 2) Inhaled
corticosteroid/long-acting beta2-agonist combination product (e. g., ADVAIR) (14 days)
Inhaled anticholinergics (e. g., Atrovent, Combivent, Spiriva) (24 hours) Theophylline
products (48 hours) Inhaled cromolyn or nedocromil (24 hours) Inhaled corticosteroids (12
hours) Long-acting beta2-agonists (e. g., Foradil, SEREVENT™) (14 days) Oral
beta2-agonists (12 hours) Inhaled short-acting beta2-agonists^b (e. g., Proventil) (6
hours) Xolair (12 months)
1. For the leukotriene modifier "exclusion period" prior to Visit 1, refer to Exclusion
Criterion 11.
2. Replaced at Visit 1 with albuterol/salbutamol.
- Ophthalmic preparations: Use of artificial tears, eyewashes, homeopathic
preparations, irrigation solutions, lubricants, sympathomimetic preparations,
vasoconstrictors, or combinations of any of the aforementioned products during
the study.
- Immunosuppressive Medications: Use of immunosuppressive medications during the
study.
NOTE: Immunotherapy for the treatment of allergies is allowed during the study, provided
that it was not initiated within 30 days of Visit 1, 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.
- Positive Pregnancy Test: A positive pregnancy test at Visit 1.
- Tobacco Use: Greater than a 10 pack-year history of cigarette smoking or use of any
tobacco products within 1 year of Visit 1. This includes cigarettes, cigars, pipe,
chewing tobacco, and snuff.
Note: Pack years = number of cigarettes smoked per day divided by 20, multiplied by the
number of years of smoking.
- Questionable Validity of Consent: Any infirmity or disability that would limit the
subject's consent or geographic location that would limit the compliance for scheduled
visits.
- Investigational Medications: Use of any investigational drug within 30 days of Visit
1.
- 3rd shift/Nighttime employment: Any employment during the nighttime hours (10 p. m. -
6 a. m.) or 3rd shift.
- Site affiliation: Participation of anyone associated with the administration of the
study or their immediate family members
GSK Clinical Trials Call Center, Birmingham, Alabama 35209, United States
GSK Clinical Trials Call Center, Scottsdale, Arizona 85251, United States
GSK Clinical Trials Call Center, Glendale, Arizona 85304, United States
GSK Clinical Trials Call Center, Tucson, Arizona 85712, United States
GSK Clinical Trials Call Center, Hot Springs, Arkansas 71913, United States
GSK Clinical Trials Call Center, Berkeley, California 94705, United States
GSK Clinical Trials Call Center, San Jose, California 95117, United States
GSK Clinical Trials Call Center, Mission Viejo, California 92691, United States
GSK Clinical Trials Call Center, Rancho, California 92270, United States
GSK Clinical Trials Call Center, San Diego, California 92120, United States
GSK Clinical Trials Call Center, San Diego, California 92120, United States
GSK Clinical Trials Call Center, Long Beach, California 90806, United States
GSK Clinical Trials Call Center, Los Angeles, California 90025, United States
GSK Clinical Trials Call Center, San Diego, California 92103-8415, United States
GSK Clinical Trials Call Center, Roseville, California 95678, United States
GSK Clinical Trials Call Center, Berkeley, California 94705, United States
GSK Clinical Trials Call Center, Riverside, California 92506, United States
GSK Clinical Trials Call Center, Riverside, California 92506, United States
GSK Clinical Trials Call Center, Stockton, California 95207, United States
GSK Clinical Call Center, Vista, California 92083, United States
GSK Clinical Trials Call Center, Los Angeles, California 90095, United States
GSK Clinical Trial Call Center, San Jose, California 95128, United States
GSK Clinical Trials Call Center, Colorado Springs, Colorado 80905, United States
GSK Clinical Trials Call Center, Boulder, Colorado 80304, United States
GSK Clinical Trials Call Center, Loveland, Colorado 80536, United States
GSK Clinical Trials Call Center, Pueblo, Colorado 81001, United States
GSK Clinical Trials Call Center, Ocala, Florida 34471, United States
GSK Clinical Trials Call Center, Tallahassee, Florida 32308, United States
GSK Clinical Trials Call Center, Brandon, Florida 33511, United States
GSK Clinical Trials Call Center, Pensacola, Florida 32504, United States
GSK Clinical Call Center, Coral Gables, Florida 33134, United States
GSK Clinical Trials Call Center, Gainesville, Georgia 30506, United States
GSK Clinical Trials Call Center, Albany, Georgia 31707, United States
GSK Clinical Trials Call Center, Savannah, Georgia 31406, United States
GSK Clinical Trials Call Center, Lawrenceville, Georgia 30045, United States
GSK Clinical Trials Call Center, Savannah, Georgia 31405, United States
GSK Clinical Trials Call Center, Atlanta, Georgia 30342, United States
GSK Clinical Trials Call Center, Columbus, Georgia 31904, United States
GSK Clinical Trials Call Center, Atlanta, Georgia 30342, United States
GSK Clinical Trials Call Center, Atlanta, Georgia 30342, United States
GSK Clinical Trials Call Center, Lawrenceville, Georgia 30045, United States
GSK Clinical Trials Call Center, Highland Park, Illinois 60035, United States
GSK Clinical Trials Call Center, Chicago, Illinois 60612, United States
GSK Clinical Trials Call Center, Springfield, Illinois 62704, United States
GSK Clinical Trials Call Center, Indianapolis, Indiana 46208, United States
GSK Clinical Trials Call Center, South Bend, Indiana 46617, United States
GSK Clinical Trials Call Center, Iowa City, Iowa 52242, United States
GSK Clinical Trials Call Center, Overland Park, Kansas 66210, United States
GSK Clinical Trials Call Center, Louisville, Kentucky 40215, United States
GSK Clinical Trials Call Center, Owensboro, Kentucky 42301, United States
GSK Clinical Trials Call Center, Lexington, Kentucky 40536, United States
GSK Clinical Trials Call Center, Sunset, Louisiana 70584, United States
GSK Clinical Trials Call Center, Shreveport, Louisiana 71105, United States
GSK Clinical Trials Call Center, Baton Rouge, Louisiana 70808, United States
GSK Clinical Trials Call Center, Covington, Louisiana 70433, United States
GSK Clinical Trials Call Center, Lafayette, Louisiana 70503, United States
GSK Clinical Trials Call Centre, Winnipeg, Manitoba R3C 0N2, Canada
GSK Clinical Trials Call Center, Baltimore, Maryland 21236, United States
GSK Clinical Trials Call Center, N. Andover, Massachusetts 01845, United States
GSK Clinical Trials Call Center, Minneapolis, Minnesota 55402, United States
GSK Clinical Trials Call Center, Jackson, Mississippi 39202, United States
GSK Clinical Trials Call Center, St. Louis, Missouri 63141, United States
GSK Clinical Trials Call Center, Jefferson City, Missouri 65101, United States
GSK Clinical Trials Call Center, Rolla, Missouri 65401, United States
GSK Clinical Trials Call Center, Papillion, Nebraska 68046, United States
GSK Clinical Trials Call Center, Omaha, Nebraska 68124, United States
GSK Clinical Trials Call Center, Lincoln, Nebraska 68505, United States
GSK Clinical Trials Call Center, Omaha, Nebraska 68131, United States
GSK Clinical Call Center, Omaha, Nebraska 68130, United States
GSK Clinical Trials Call Center, Las Vegas, Nevada 89106, United States
GSK Clinical Trials Call Center, Forked River, New Jersey 08731, United States
GSK Clinical Trials Call Center, Summit, New Jersey 07901, United States
GSK Clinical Trials Call Center, Rochester, New York 14618, United States
GSK Clinical Trials Call Center, Jacksonville, North Carolina 32207, United States
GSK Clinical Trials Call Center, Asheville, North Carolina 28801, United States
GSK Clinical Trials Call Center, Raleigh, North Carolina 27607, United States
GSK Clinical Trials Call Center, Canton, Ohio 44718, United States
GSK Clinical Trials Call Center, Parma, Ohio 44129, United States
GSK Clinical Trials Call Center, Cincinnati, Ohio 45241, United States
GSK Clinical Trials Call Center, Akron, Ohio 44333, United States
GSK Clinical Trials Call Center, Oklahoma City, Oklahoma 73120, United States
GSK Clinical Trials Call Center, Sudbury, Ontario P3E 1H5, Canada
GSK Clinical Trials Call Center, Brampton, Ontario L6T 3T1, Canada
GSK Clinical Trials Call Center, Mississauga, Ontario L5A 3V4, Canada
GSK Clinical Trials Call Center, Kanata, Ontario K2L 3C8, Canada
GSK Clinical Trials Call Center, Ottawa, Ontario K2C 3R2, Canada
GSK Clinical Trials Call Center, Ottawa, Ontario K1N 6N5, Canada
GSK Clinical Trials Call Center, Niagra Falls, Ontario L2G 1J4, Canada
GSK Clinical Trials Call Center, Ajax, Ontario L1S 2J5, Canada
GSK Clinical Trials Call Center, Bend, Oregon 97701, United States
GSK Clinical Trials Call Center, Portland, Oregon 97213, United States
GSK Clinical Trials Call Center, Upland, Pennsylvania 19013, United States
GSK Clinical Trials Call Center, Lemoyne, Pennsylvania 17043, United States
GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15241-1080, United States
GSK Clinical Trials Call Center, Quebec City, Quebec G1M 3L7, Canada
GSK Clinical Trials Call Center, Trois-Rivieres, Quebec G8T 7A1, Canada
GSK Clinical Trials Call Center, Quebec City, Quebec G1V 4M6, Canada
GSK Clinical Trials Call Center, Providence, Rhode Island 02906, United States
GSK Clinical Trials Call Center, Orangeburg, South Carolina 29118, United States
GSK Clinical Trials Call Center, Charleston, South Carolina 29407, United States
GSK Clinical Trials Call Center, Spartanburg, South Carolina 29303, United States
GSK Clinical Trials Call Center, Simpsonville, South Carolina 29681, United States
GSK Clinical Trials Call Center, Charleston, South Carolina 29414, United States
GSK Clinical Trials Call Center, Greenville, South Carolina 29604, United States
GSK Clinical Trials Call Center, Mt. Pleasant, South Carolina 29464, United States
GSK Clinical Trials Call Center, Savannah, Tennessee 38372, United States
GSK Clinical Trials Call Center, Knoxville, Tennessee 37992, United States
GSK Clinical Trials Call Center, Germantown, Tennessee 38138, United States
GSK Clinical Trials Call Center, Knoxville, Tennessee 37909, United States
GSK Clinical Trials Call Center, Chattanooga, Tennessee 37421, United States
GSK Clinical Trials Call Center, Waco, Texas 76708, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, Dallas, Texas 75246, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78217, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78233, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, Galveston, Texas 77555, United States
GSK Clinical Trials Call Center, Dallas, Texas 75246, United States
GSK Clinical Trials Call Center, Kerrville, Texas 78028, United States
GSK Clinical Trials Call Center, Dallas, Texas 75240, United States
GSK Clinical Trials Call Center, Austin, Texas 78704, United States
GSK Clinical Trials Call Center, Dallas, Texas 75230, United States
GSK Clinical Trials Call Center, Austin, Texas 78750, United States
GSK Clinical Trials Call Center, El Paso, Texas 79902, United States
GSK Clinical Trials Call Center, Houston, Texas 77054, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78205, United States
GSK Clinical Trials Call Center, El Paso, Texas 79925, United States
GSK Clinical Trials Call Center, Dallas, Texas 75231, United States
GSK Clinical Trials Call Center, Houston, Texas 77070, United States
GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States
GSK Clinical Trials Call Center, Jordan, Utah 84084, United States
GSK Clinical Trials Call Center, Salt Lake City, Utah 84121, United States
GSK Clinical Trials Call Center, Danville, Virginia 24541, United States
GSK Clinical Trials Call Center, Richmond, Virginia 23219, United States
GSK Clinical Trials Call Center, Kirkland, Washington 98034, United States
GSK Clinical Trials Call Center, Spokane, Washington 99224, United States
