Study Of Allergic Rhinitis In Patients Who Also Have Asthma
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
1 other identifier
interventional
725
4 countries
121
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Sep 2005
Typical duration for phase_4 asthma
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 27, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
May 13, 2009
CompletedDecember 16, 2016
November 1, 2016
2.1 years
February 23, 2006
October 31, 2008
November 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
Baseline to Endpoint (weeks 3-4)
Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
Baseline to Endpoint (weeks 3-4)
Secondary Outcomes (8)
Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).
Baseline to 1-2 Weeks
Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)
Baseline To 1-2 Weeks
Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population
Baseline to Endpoint (weeks 3-4)
Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population
Baseline to Endpoint (weeks 3-4)
Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population
Baseline to Endpoint (weeks 3-4)
- +3 more secondary outcomes
Study Arms (4)
Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)
ACTIVE COMPARATORFluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD
Fluticasone Propionate/Salmeterol (FSC)
ACTIVE COMPARATORFSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD
Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)
ACTIVE COMPARATORFluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD
Montelukast (MON)
ACTIVE COMPARATORPlacebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Interventions
fluticasone propionate/salmeterol DISKUS combination
montelukast capsule
fluticasone propionate aqueous nasal spray
vehicle placebo nasal spray
ADVAIR DISKUS
placebo capsule
Eligibility Criteria
You may qualify if:
- 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 \[Hankinson, 1999\].
- +7 more criteria
You may not qualify if:
- 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
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (121)
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
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
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
Providence, Rhode Island, 02906, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Charleston, South Carolina, 29414, 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, 75230, United States
GSK Investigational Site
Dallas, Texas, 75231-4307, United States
GSK Investigational Site
Dallas, Texas, 75240, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
El Paso, Texas, 79902, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
Houston, Texas, 77054, United States
GSK Investigational Site
Houston, Texas, 77070, 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
GSK Investigational Site
Winnipeg, Manitoba, R3C 0N2, Canada
GSK Investigational Site
Ajax, Ontario, L1S 2J5, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, 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
Québec, Quebec, G1V 4M6, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
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
Related Publications (1)
Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, Ortega HG. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy Asthma Proc. 2010 Jan-Feb;31(1):68-75. doi: 10.2500/aap.2010.31.3306.
PMID: 20167147DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 27, 2006
Study Start
September 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
December 16, 2016
Results First Posted
May 13, 2009
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.