Last updated: 11/04/2018 04:29:54
Study Of Allergic Rhinitis In Patients Who Also Have Asthma
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean Change from Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population
Timeframe: Baseline to Endpoint (weeks 3-4)
Mean Change from Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population
Timeframe: Baseline to Endpoint (weeks 3-4)
Secondary outcomes:
Rhinitis: Mean Change from Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).
Timeframe: Baseline to 1-2 Weeks
Rhinitis: Mean Change from Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)
Timeframe: Baseline To 1-2 Weeks
Asthma: Mean Change from Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population
Timeframe: Baseline to Endpoint (weeks 3-4)
Asthma: Mean Change from Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population
Timeframe: 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
Timeframe: Baseline to Endpoint (weeks 3-4)
Asthma: Mean Change from Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population
Timeframe: Baseline to Endpoint (weeks 3-4)
Asthma: Mean Change from Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population
Timeframe: Baseline to Endpoint (weeks 3-4)
Asthma: Mean Change from Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population
Timeframe: Baseline to Endpoint (weeks 3-4)
Interventions:
Drug: fluticasone propionate/salmeterol (FSC)
Drug: montelukast (MON)
Drug: fluticasone propionate (FP)
Drug: placebo nasal
Drug: ADVAIR DISKUS
Drug: placebo capsule
Drug: placebo DISKUS
Enrollment:
725
Observational study model:
Not applicable
Primary completion date:
2007-31-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
September 2005 to October 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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 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].
- 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.
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.
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.
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.
- 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) a.For the leukotriene modifier "exclusion period" prior to Visit 1, refer to Exclusion Criterion 11. b.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
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
Trial location(s)
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77070
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boulder, Colorado, United States, 80304
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37909
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Ocala, Florida, United States, 34471
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ottawa, Ontario, Canada, K2C 3R2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Study Complete
Location
GSK Investigational Site
Stockton, California, United States, 95207
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Forked River, New Jersey, United States, 08731
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84084
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536
Status
Study Complete
Location
GSK Investigational Site
Berkeley, California, United States, 94705
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31405
Status
Study Complete
Location
GSK Investigational Site
North Andover, Massachusetts, United States, 01845
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Study Complete
Location
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
Status
Study Complete
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95117
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29607
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Vista, California, United States, 92083
Status
Study Complete
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Kirkland, Washington, United States, 98034
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90025
Status
Study Complete
Location
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95678
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29414
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95128
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02906
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Papillion, Nebraska, United States, 68046
Status
Study Complete
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65101
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21236
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66210
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23298
Status
Study Complete
Location
GSK Investigational Site
Kerrville, Texas, United States, 78028
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85304
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tucson, Arizona, United States, 85712
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pensacola, Florida, United States, 32504
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
Status
Study Complete
Location
GSK Investigational Site
Summit, New Jersey, United States, 07091
Status
Study Complete
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Study Complete
Location
GSK Investigational Site
Iowa City, Iowa, United States, 52242
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Springfield, Illinois, United States, 62704
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Study Complete
Location
GSK Investigational Site
Niagara Falls, Ontario, Canada, L2G 1J4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80526
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Savannah, Tennessee, United States, 38372
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Danville, Virginia, United States, 24541
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ottawa, Ontario, Canada, K1N 6N5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78233
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-31-10
Actual study completion date
2007-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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