Study Of Allergic Rhinitis In Patients Who Also Have Asthma

Overview[ - collapse ][ - ]

Purpose 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.
ConditionAsthma
Allergic Rhinitis
InterventionDrug: montelukast
Drug: fluticasone propionate
Drug: fluticasone propionate/salmeterol
PhasePhase 4
SponsorGlaxoSmithKline
Responsible PartyGlaxoSmithKline
ClinicalTrials.gov IdentifierNCT00296491
First ReceivedFebruary 23, 2006
Last UpdatedJune 18, 2009
Last verifiedJune 2009

Tracking Information[ + expand ][ + ]

First Received DateFebruary 23, 2006
Last Updated DateJune 18, 2009
Start DateSeptember 2005
Estimated Primary Completion DateOctober 2007
Current Primary Outcome Measures
  • Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]
  • Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS). [Time Frame: Baseline to 1-2 Weeks] [Designated as safety issue: No]
  • Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS) [Time Frame: Baseline To 1-2 Weeks] [Designated as safety issue: No]
  • Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]
  • Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]
  • Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]
  • Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]
  • Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]
  • Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population [Time Frame: Baseline to Endpoint (weeks 3-4)] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleStudy Of Allergic Rhinitis In Patients Who Also Have Asthma
Official TitleSee Detailed Description
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.
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
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition
  • Asthma
  • Allergic Rhinitis
InterventionDrug: montelukast
montelukast
Drug: fluticasone propionate
fluticasone propionate
Other Names:
  • fluticasone propionate
  • montelukast
  • fluticasone propionate/salmeterol
Drug: fluticasone propionate/salmeterol
fluticasone propionate/salmeterol
Study Arm (s)
  • Active Comparator: fluticasone propionate/salmeterol
  • Active Comparator: fluticasone propionate
  • Active Comparator: montelukast

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment725
Estimated Completion DateOctober 2007
Estimated Primary Completion DateOctober 2007
Eligibility 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
GenderBoth
Ages15 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Canada, Estonia, Poland

Administrative Information[ + expand ][ + ]

NCT Number NCT00296491
Other Study ID NumbersADA103575
Has Data Monitoring CommitteeNot Provided
Information Provided ByGlaxoSmithKline
Study SponsorGlaxoSmithKline
CollaboratorsNot Provided
Investigators Study Director: GSK Clinical Trials GlaxoSmithKline
Verification DateJune 2009

Locations[ + expand ][ + ]

GSK Investigational Site
Birmingham, Alabama, United States, 35209
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
GSK Investigational Site
Tucson, Arizona, United States, 85712
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
GSK Investigational Site
Berkeley, California, United States, 94705
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Los Angeles, California, United States, 90025
GSK Investigational Site
Rancho Mirage, California, United States, 92270
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
Roseville, California, United States, 95678
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
San Jose, California, United States, 95128
GSK Investigational Site
San Jose, California, United States, 95117
GSK Investigational Site
Stockton, California, United States, 95207
GSK Investigational Site
Vista, California, United States, 92083
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Lakewood, Colorado, United States, 80401
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Pensacola, Florida, United States, 32504
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Albany, Georgia, United States, 31707
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Columbus, Georgia, United States, 31904
GSK Investigational Site
Gainesville, Georgia, United States, 30501
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Savannah, Georgia, United States, 31405
GSK Investigational Site
Savannah, Georgia, United States, 31406
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Springfield, Illinois, United States, 62704
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
GSK Investigational Site
South Bend, Indiana, United States, 46617
GSK Investigational Site
Iowa City, Iowa, United States, 52242
GSK Investigational Site
Overland Park, Kansas, United States, 66210
GSK Investigational Site
Lexington, Kentucky, United States, 40536
GSK Investigational Site
Louisville, Kentucky, United States, 40215
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
GSK Investigational Site
Covington, Louisiana, United States, 70433
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
GSK Investigational Site
Shreveport, Louisiana, United States, 71105
GSK Investigational Site
Sunset, Louisiana, United States, 70584
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
North Andover, Massachusetts, United States, 01845
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
GSK Investigational Site
Jackson, Mississippi, United States, 39202
GSK Investigational Site
Jefferson City, Missouri, United States, 65101
GSK Investigational Site
Rolla, Missouri, United States, 65401
GSK Investigational Site
St. Louis, Missouri, United States, 63141
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
GSK Investigational Site
Omaha, Nebraska, United States, 68124
GSK Investigational Site
Omaha, Nebraska, United States, 68130
GSK Investigational Site
Omaha, Nebraska, United States, 68131
GSK Investigational Site
Papillion, Nebraska, United States, 68046
GSK Investigational Site
Forked River, New Jersey, United States, 08731
GSK Investigational Site
Summit, New Jersey, United States, 07091
GSK Investigational Site
Rochester, New York, United States, 14618
GSK Investigational Site
Asheville, North Carolina, United States, 28801
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
GSK Investigational Site
Parma, Ohio, United States, 44129
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
GSK Investigational Site
Bend, Oregon, United States, 97701
GSK Investigational Site
Portland, Oregon, United States, 97213
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
GSK Investigational Site
Providence, Rhode Island, United States, 02906
GSK Investigational Site
Charleston, South Carolina, United States, 29407
GSK Investigational Site
Charleston, South Carolina, United States, 29414
GSK Investigational Site
Greenville, South Carolina, United States, 29607
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
GSK Investigational Site
Germantown, Tennessee, United States, 38138
GSK Investigational Site
Knoxville, Tennessee, United States, 37909
GSK Investigational Site
Savannah, Tennessee, United States, 38372
GSK Investigational Site
Austin, Texas, United States, 78750
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Dallas, Texas, United States, 75231-4307
GSK Investigational Site
Dallas, Texas, United States, 75240
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
El Paso, Texas, United States, 79902
GSK Investigational Site
El Paso, Texas, United States, 79925
GSK Investigational Site
Houston, Texas, United States, 77070
GSK Investigational Site
Houston, Texas, United States, 77054
GSK Investigational Site
Kerrville, Texas, United States, 78028
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
San Antonio, Texas, United States, 78233
GSK Investigational Site
Waco, Texas, United States, 76708
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
West Jordan, Utah, United States, 84084
GSK Investigational Site
Danville, Virginia, United States, 24541
GSK Investigational Site
Richmond, Virginia, United States, 23298
GSK Investigational Site
Kirkland, Washington, United States, 98034
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
GSK Investigational Site
Ajax, Ontario, Canada, L1S 2J5
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3T1
GSK Investigational Site
Kanata, Ontario, Canada, K2L 3C8
GSK Investigational Site
Mississauga, Ontario, Canada, L5A 3V4
GSK Investigational Site
Ottawa, Ontario, Canada, K1N 6N5
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
GSK Investigational Site
Quebec City, Quebec, Canada, G1V 4M6
GSK Investigational Site
Trois Rivières, Quebec, Canada, G8T 7A1
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
GSK Investigational Site
Bialystok, Poland, 15-025
GSK Investigational Site
Bialystok, Poland, 15-274
GSK Investigational Site
Krakow, Poland, 31-023
GSK Investigational Site
Lodz, Poland, 93-513