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Study Of Allergic Rhinitis In Patients Who Also Have Asthma

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

Condition(s) targeted: Asthma

Intervention: fluticasone propionate/salmeterol (FSC) (Drug); montelukast (MON) (Drug); fluticasone propionate (FP) (Drug); placebo nasal (Drug); ADVAIR DISKUS (Drug); placebo capsule (Drug); placebo DISKUS (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

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.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD Versus Montelukast 10mg QD in Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Who Are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

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

Primary outcome:

Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population

Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population

Secondary outcome:

Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).

Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)

Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population

Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population

Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population

Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population

Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population

Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population

Detailed description: A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Eligibility

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

GSK Investigational Site, Tallinn 13419, Estonia

GSK Investigational Site, Tartu 51014, Estonia

GSK Investigational Site, Bialystok 15-025, Poland

GSK Investigational Site, Bialystok 15-274, Poland

GSK Investigational Site, Krakow 31-023, Poland

GSK Investigational Site, Lodz 93-513, Poland

GSK Investigational Site, Birmingham, Alabama 35209, United States

GSK Investigational Site, Glendale, Arizona 85304, United States

GSK Investigational Site, Scottsdale, Arizona 85251, United States

GSK Investigational Site, Tucson, Arizona 85712, United States

GSK Investigational Site, Hot Springs, Arkansas 71913, United States

GSK Investigational Site, Berkeley, California 94705, United States

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

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

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

GSK Investigational Site, Rancho Mirage, California 92270, United States

GSK Investigational Site, Riverside, California 92506, United States

GSK Investigational Site, Roseville, California 95678, United States

GSK Investigational Site, San Diego, California 92103, United States

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

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

GSK Investigational Site, San Jose, California 95128, United States

GSK Investigational Site, Stockton, California 95207, United States

GSK Investigational Site, Vista, California 92083, United States

GSK Investigational Site, Boulder, Colorado 80304, United States

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

GSK Investigational Site, Fort Collins, Colorado 80526, United States

GSK Investigational Site, Lakewood, Colorado 80401, United States

GSK Investigational Site, Brandon, Florida 33511, United States

GSK Investigational Site, Coral Gables, Florida 33134, United States

GSK Investigational Site, Ocala, Florida 34471, United States

GSK Investigational Site, Pensacola, Florida 32504, United States

GSK Investigational Site, Tallahassee, Florida 32308, United States

GSK Investigational Site, Albany, Georgia 31707, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Columbus, Georgia 31904, United States

GSK Investigational Site, Gainesville, Georgia 30501, United States

GSK Investigational Site, Lawrenceville, Georgia 30045, United States

GSK Investigational Site, Savannah, Georgia 31405, United States

GSK Investigational Site, Savannah, Georgia 31406, United States

GSK Investigational Site, Chicago, Illinois 60612, United States

GSK Investigational Site, Springfield, Illinois 62704, United States

GSK Investigational Site, Indianapolis, Indiana 46208, United States

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

GSK Investigational Site, Iowa City, Iowa 52242, United States

GSK Investigational Site, Overland Park, Kansas 66210, United States

GSK Investigational Site, Lexington, Kentucky 40536, United States

GSK Investigational Site, Louisville, Kentucky 40215, United States

GSK Investigational Site, Owensboro, Kentucky 42301, United States

GSK Investigational Site, Baton Rouge, Louisiana 70808, United States

GSK Investigational Site, Covington, Louisiana 70433, United States

GSK Investigational Site, Lafayette, Louisiana 70503, United States

GSK Investigational Site, Shreveport, Louisiana 71105, United States

GSK Investigational Site, Sunset, Louisiana 70584, United States

GSK Investigational Site, Winnipeg, Manitoba R3C 0N2, Canada

GSK Investigational Site, Baltimore, Maryland 21236, United States

GSK Investigational Site, North Andover, Massachusetts 01845, United States

GSK Investigational Site, Minneapolis, Minnesota 55402, United States

GSK Investigational Site, Jackson, Mississippi 39202, United States

GSK Investigational Site, Jefferson City, Missouri 65101, United States

GSK Investigational Site, Rolla, Missouri 65401, United States

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

GSK Investigational Site, Warrensburg, Missouri 64093, United States

GSK Investigational Site, Lincoln, Nebraska 68505, United States

GSK Investigational Site, Omaha, Nebraska 68124, United States

GSK Investigational Site, Omaha, Nebraska 68130, United States

GSK Investigational Site, Omaha, Nebraska 68131, United States

GSK Investigational Site, Papillion, Nebraska 68046, United States

GSK Investigational Site, Forked River, New Jersey 08731, United States

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

GSK Investigational Site, Rochester, New York 14618, 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 45242, United States

GSK Investigational Site, Parma, Ohio 44129, United States

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

GSK Investigational Site, Ajax, Ontario L1S 2J5, Canada

GSK Investigational Site, Brampton, Ontario L6T 3T1, Canada

GSK Investigational Site, Kanata, Ontario K2L 3C8, Canada

GSK Investigational Site, Mississauga, Ontario L5A 3V4, Canada

GSK Investigational Site, Niagara Falls, Ontario L2G 1J4, Canada

GSK Investigational Site, Ottawa, Ontario K1N 6N5, Canada

GSK Investigational Site, Ottawa, Ontario K2C 3R2, Canada

GSK Investigational Site, Sudbury, Ontario P3E 1H5, Canada

GSK Investigational Site, Bend, Oregon 97701, United States

GSK Investigational Site, Portland, Oregon 97213, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15241, United States

GSK Investigational Site, Upland, Pennsylvania 19013, United States

GSK Investigational Site, Quebec City, Quebec G1V 4M6, Canada

GSK Investigational Site, Trois Rivières, Quebec G8T 7A1, Canada

GSK Investigational Site, Providence, Rhode Island 02906, United States

GSK Investigational Site, Charleston, South Carolina 29414, United States

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

GSK Investigational Site, Greenville, South Carolina 29607, United States

GSK Investigational Site, Orangeburg, South Carolina 29118, United States

GSK Investigational Site, Simpsonville, South Carolina 29681, United States

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

GSK Investigational Site, Chattanooga, Tennessee 37421, United States

GSK Investigational Site, Germantown, Tennessee 38138, United States

GSK Investigational Site, Knoxville, Tennessee 37909, United States

GSK Investigational Site, Savannah, Tennessee 38372, United States

GSK Investigational Site, Austin, Texas 78750, United States

GSK Investigational Site, Dallas, Texas 75240, United States

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

GSK Investigational Site, Dallas, Texas 75246, United States

GSK Investigational Site, Dallas, Texas 75230, United States

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

GSK Investigational Site, El Paso, Texas 79902, United States

GSK Investigational Site, Houston, Texas 77070, United States

GSK Investigational Site, Houston, Texas 77054, United States

GSK Investigational Site, Kerrville, Texas 78028, United States

GSK Investigational Site, San Antonio, Texas 78205, United States

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

GSK Investigational Site, San Antonio, Texas 78233, United States

GSK Investigational Site, Waco, Texas 76708, United States

GSK Investigational Site, Salt Lake City, Utah 84121, United States

GSK Investigational Site, West Jordan, Utah 84084, United States

GSK Investigational Site, Danville, Virginia 24541, United States

GSK Investigational Site, Richmond, Virginia 23298, United States

GSK Investigational Site, Kirkland, Washington 98034, United States

Additional Information

Starting date: September 2005
Last updated: June 11, 2015

Page last updated: August 23, 2015

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