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A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00603278
First received: December 27, 2007
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Condition Intervention Phase
Asthma
Drug: GW685698X
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 250mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Low-Dose ICS Therapy

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 [ Time Frame: Baseline and Week 8 ]
    Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.


Secondary Outcome Measures:
  • Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period [ Time Frame: From Baseline up to Week 8 ]
    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily evening PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough evening PEF, country, sex, age, and treatment group.

  • Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period [ Time Frame: From Baseline up to Week 8 ]
    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the PEF measurement performed at the end of the dosing interval. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three attempts was recorded by the participants in a daily diary. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily morning PEF over the 8-week treatment period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline trough morning PEF, country, sex, age, and treatment group.

  • Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period [ Time Frame: From Baseline up to Week 8 ]
    Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of Baseline, country, sex, age, and treatment group.

  • Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period [ Time Frame: From Baseline up to Week 8 ]
    The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily diary. A 24-hr period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue-free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 8-week Treatment Period minus the value at Baseline. The analysis was performed using an ANCOVA model with covariates of baseline, country, sex, age, and treatment group.

  • Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period [ Time Frame: From the first dose of study medication up to Week 8/Early Withdrawal ]
    The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.

  • Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period [ Time Frame: From the first dose of study medication up to Week 8/Early Withdrawal ]
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=3%) and SAEs.

  • Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis [ Time Frame: From Baseline up to Week 8/Early Withdrawal ]
    A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed for the entire Treatment Period.

  • Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

  • Hematocrit at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of Hematocrit at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

  • Hemoglobin at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of hemoglobin at Baseline (BL)and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

  • Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of platelet count and WBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

  • Red Blood Cells (RBC) Count at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of RBC count at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

  • Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of ALP, ALT, AST, LD and GGT at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).

  • Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of albumin and total protein at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).

  • Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen (BUN) at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

  • Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    Blood samples were collected for the measurement of DBIL, TBIL, uric acid and creatinine at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

  • Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal [ Time Frame: Baseline and Week 8/Early Withdrawal ]
    Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 grams per deciliter (G/dL), 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, Trace, 1+, 2+, 3+ and 4+ levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (WD). The Baseline value was the measurement taken at screening (Visit 1).

  • Urine Specific Gravity at Baseline and Week 8/Early Withdrawal [ Time Frame: Urine specific gravity at Baseline and Week 8/Early Withdrawal ]
    Urine samples were collected for the measurement of urine specific gravity by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.

  • Urine pH at Baseline and Week 8/Early Withdrawal [ Time Frame: Baseline and Week 8/Early Withdrawal ]
    Urine samples were collected for the measurement of urine pH by dipstick method at Baseline and at Week 8/Early Withdrawal. The Baseline value was the measurement taken at screening (Visit 1). Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

  • 24-hour Urinary Cortisol Excretion at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    A 24-hour urine sample was collected for the measurement of 24-hour urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visit 3 (Baseline; Week 0) and Study Visit 8 (Week 8). The Baseline value for 24-hour urinary cortisol was taken from Visit 3.

  • Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8 [ Time Frame: Baseline and Week 8 ]
    Change from Baseline was calculated as the Week 8 value minus the Baseline value.

  • Change From Baseline in Heart Rate at Week 8 [ Time Frame: Baseline and Week 8 ]
    Change from Baseline was calculated as the Week 8 value minus the Baseline value.


Enrollment: 622
Study Start Date: December 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1 Drug: placebo
placebo
Experimental: Arm 2 Drug: GW685698X
GW685698X

Detailed Description:
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Low-Dose ICS Therapy
  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Subjects eligible for enrolment in the study must meet all of the following criteria:

  • Type of Subject: Outpatient
  • Age: 12 years of age or older at Visit 1. For sites in the following countries, subjects recruited will be ≥18 years of age: Bulgaria, Czech Republic, Germany, Greece, Lithuania, New Zealand, Russian Federation, Turkey and any other countries where local regulations or the regulatory status of study medication permit enrolment of adults only.
  • Gender: Male or Eligible Female
  • To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control, as defined by the following:
  • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
  • Implants of levonorgestrel
  • Injectable progestogen
  • Oral contraceptive (either combined estrogen/progestin or progestin only)
  • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
  • Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days).
  • Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm).
  • NB: For German sites, female subjects must use a method of birth control other than the double barrier method.
  • The contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds)
  • Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required of all females. This test will be performed at the initial screening visit (Visit 1) and Visit 8. In addition, a urine pregnancy test will be performed on the evening of the double-blind treatment visit, prior to randomization (Visit 3) and at Visits 4 through 7.
  • Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National Institutes of Health, 2007].
  • Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value during Visit 1. NHANES III predicted values will be used for subjects aged ≥ 12 years and adjustments to predicted values will be made for African American subjects. [Hankinson, 1999].
  • Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1 within approximately 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) or one nebulized albuterol/salbutamol solution at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥12% and ≥200mL, then the subject is not eligible for the study and will not be allowed to re-screen.
  • Current Anti-Asthma Therapy: Subjects must have been using a inhaled corticosteroid for at least 8 weeks prior to Visit 1 and maintained on a stable dose of inhaled corticosteroids for four weeks prior to Visit 1 at one of the following doses: [fluticasone propionate MDI CFC/HFA >220mcg exactuator or ≤250mcg ex valve]; [fluticasone propionate DPI ≤200mcg]; [beclomethasone dipropionate DPI ≤ 420mcg exactuator or ≤ 500mcg ex-valve]; [beclomethasone dipropionate HFA (Qvar) ≤ 160mcg exactuator or ≤ 200mcg ex-valve]; [budesonide DPI MDI ≤400mcg]; [flunisolide ≤ 1000mcg]; [triamcinolone acetonide ≤1000mcg]; [mometasone furoate DPI >200mcg or ≤ 220mcg]; [ciclesonide MDI HFA ≤ 160mcg ex-actuator dose / ≤ 200mcg ex-valve dose].
  • Short- Acting Beta2-Agonists: All subjects must be able to replace their current short-acting beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use as needed for the duration of the study. The use of spacer devices with metered dose inhaler (MDI) or nebulized albuterol/salbutamol will not be allowed during the study with the exception of their use during reversibility testing at Visit 1. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits.
  • Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study.
  • Compliance: Subjects must be able to comply with completion of the Daily Diary (includes paper medical conditions diary).
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Inclusion Criteria for Randomization

At the end of the run-in period, a subject will be eligible to enter the treatment period of the study if he/she meets the following criteria at Visit 3:

  1. Evening pre-dose percent predicted FEV1 of between 40% and 90% of their predicted normal.
  2. Any combination of the daily asthma symptom scores (day-time plus night-time) of ≥1 or albuterol/salbutamol use on at least 4 of the last 7 consecutive days of the run-in period (immediately preceding Visit 3).

EXCLUSION CRITERIA:

  • History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
  • Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
  • Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1. A subject must not have had any hospitalization for asthma within 6 months prior to Visit 1.
  • Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease including, but not limited to: cardiovascular disease, hepatic disease, renal disease, hematological disease, neurological disease, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. The list of additional excluded conditions/diseases includes, but is not limited to the following: congestive heart failure, clinically significant coronary artery disease, stroke within 3 months of Visit 1, poorly controlled peptic ulcer, immunologic compromise, tuberculosis (current or untreated), Addison's disease, uncontrolled thyroid disorder, known aortic aneurysm, clinically significant cardiac arrhythmia, uncontrolled hypertension, hematological, hepatic, or renal disease, current malignancy, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse.
  • Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of oral candidiasis at Visit 1.
  • Investigational Medications: A subject must not have participated in a study or used any investigational drug within 30 days prior to Visit 1.
  • Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the novel dry powder inhaler or DISKUS/ACCUHALER (i.e., lactose or magnesium stearate).
  • Milk Protein Allergy: History of severe milk protein allergy.
  • Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study.

NOTE: Immunotherapy for the treatment of allergies is allowed during the study provided that the treatment was initiated prior to Visit 1 and the subject is maintained on a stable regimen throughout the study period.

  • Attendance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol or scheduled visits to the study center and non-compliant with study medication or procedures (e.g. completion of daily diary). Neurological or psychiatric disease or history of drug or alcohol abuse which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements excludes study participation.
  • Tobacco Use : Current smoker or a smoking history of 10 pack years or more (e.g. 20 cigarettes/day for 10 years). A subject may not have used tobacco products within the past one year (i.e., cigarettes, cigars, or pipe tobacco).
  • Affiliation with Investigator's Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub‑Investigator, study coordinator, or employee of the participating Investigator.
  • Corticosteroid Use: Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1.
  • Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: Patients who are receiving potent CYP3A4 inhibitors within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).

Exclusion Criteria for Randomization At the end of the run-in period, a subject will not be eligible to enter the treatment period of the study if they meet any of the following criteria.

  1. Clinical Laboratory Abnormalities: Clinically significant abnormal laboratory tests during Visit 1 which are still abnormal upon repeat analysis and are not believed to be due to disease(s) present. Each Investigator will use his/her own discretion in determining the clinical significance of the abnormality. When in doubt, GlaxoSmithKline, or designee, should be notified so that a joint decision can be made.
  2. Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1).
  3. Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
  4. Asthma exacerbation, defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol or regular inhaled corticosteroid use. This includes requiring the use of systemic corticosteroids and / or emergency room visit or hospitalization or a change in subject's regular inhaled corticosteroid dose.
  5. A subject will not be eligible for randomization if he/she has an abnormal visual oropharyngeal exam at the randomization Visit 3 (visual clinical evidence of oral candidiasis).
  6. Non-compliance with completion of the Daily Diary, defined as: -Completion of AM and PM symptom scores on less than 4 days out of the last 7 days immediately preceding Visit 3.

    • Completion of AM and PM rescue use on less than 4 days out of the last 7 days immediately preceding Visit 3.
    • Completion of AM and PM PEF measurements on less than 4 days out of the last 7 days immediately preceding Visit 3.
    • Recording run-in asthma medication use on less than 4 days out of the last 7 days immediately preceding Visit 3.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603278

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85028
United States, Arkansas
GSK Investigational Site
Fort Smith, Arkansas, United States, 72903
GSK Investigational Site
Little Rock, Arkansas, United States, 72211-3733
United States, California
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Granada Hills, California, United States, 91344
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
Los Angeles, California, United States, 90095-1752
GSK Investigational Site
Palmdale, California, United States, 93551
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
Roseville, California, United States, 95678
GSK Investigational Site
San Diego, California, United States, 92120
GSK Investigational Site
Torrance, California, United States, 90505
GSK Investigational Site
Walnut Creek, California, United States, 94598
GSK Investigational Site
West Covina, California, United States, 91790
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80910
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
GSK Investigational Site
Bridgeport, Connecticut, United States, 06606
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33487
GSK Investigational Site
Cocoa, Florida, United States, 32927
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
GSK Investigational Site
Largo, Florida, United States, 33770
GSK Investigational Site
Miami, Florida, United States, 33126
GSK Investigational Site
Miami, Florida, United States, 33157
GSK Investigational Site
Ocala, Florida, United States, 34471
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
GSK Investigational Site
Winter Park, Florida, United States, 32789
United States, Georgia
GSK Investigational Site
Gainesville, Georgia, United States, 30501
United States, Illinois
GSK Investigational Site
Bloomingdale/Illinois, Illinois, United States, 60108
GSK Investigational Site
Chicago, Illinois, United States, 60617
GSK Investigational Site
DeKalb, Illinois, United States, 60115
GSK Investigational Site
Gurnee, Illinois, United States, 60031
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47713
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52240
United States, Kansas
GSK Investigational Site
Lenexa, Kansas, United States, 66215
United States, Kentucky
GSK Investigational Site
Crescent Springs, Kentucky, United States, 41017
GSK Investigational Site
Lexington, Kentucky, United States, 40536
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70002
United States, Maine
GSK Investigational Site
Bangor, Maine, United States, 04401
United States, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48221
GSK Investigational Site
Taylor, Michigan, United States, 48180
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Rolla, Missouri, United States, 65401
GSK Investigational Site
St. Louis, Missouri, United States, 63141
GSK Investigational Site
St. Louis, Missouri, United States, 63143
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
United States, Montana
GSK Investigational Site
Billings, Montana, United States, 59101
GSK Investigational Site
Butte, Montana, United States, 59701
GSK Investigational Site
Missoula, Montana, United States, 59808
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89107
United States, New Jersey
GSK Investigational Site
Clifton/New Jersey, New Jersey, United States, 7011
GSK Investigational Site
Hillsborough, New Jersey, United States, 08844
GSK Investigational Site
Red Bank, New Jersey, United States, 07701
GSK Investigational Site
Skillman, New Jersey, United States, 08558
United States, New York
GSK Investigational Site
Bronx, New York, United States, 10461
GSK Investigational Site
East Syracuse, New York, United States, 13057
GSK Investigational Site
Ithaca, New York, United States, 14850
GSK Investigational Site
Rockville Center, New York, United States, 11570
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
GSK Investigational Site
Greenville, North Carolina, United States, 27834
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
GSK Investigational Site
Cleveland, Ohio, United States, 44113
GSK Investigational Site
Columbus, Ohio, United States, 43235
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
GSK Investigational Site
Bluffton, South Carolina, United States, 29910
GSK Investigational Site
Charleston, South Carolina, United States, 29406
GSK Investigational Site
Charleston, South Carolina, United States, 29414
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37909
United States, Texas
GSK Investigational Site
Boerne, Texas, United States, 78006
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Dickinson, Texas, United States, 77539
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Plano, Texas, United States, 75093
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78233
GSK Investigational Site
Waco, Texas, United States, 76712
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
United States, Virginia
GSK Investigational Site
Manassas, Virginia, United States, 22015
United States, Washington
GSK Investigational Site
Bellingham, Washington, United States, 98225
GSK Investigational Site
Spokane, Washington, United States, 99204
GSK Investigational Site
Spokane, Washington, United States, 99207
Canada, Newfoundland and Labrador
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Canada, Ontario
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3T1
GSK Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4G2
GSK Investigational Site
Toronto, Ontario, Canada, M3H 5S4
Canada, Quebec
GSK Investigational Site
Quebec City, Quebec, Canada, G1V 4M6
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G5
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tallinn, Estonia, 13619
GSK Investigational Site
Tartu, Estonia, 51014
Germany
GSK Investigational Site
Schwetzingen, Baden-Wuerttemberg, Germany, 68723
GSK Investigational Site
Sinsheim, Baden-Wuerttemberg, Germany, 74889
GSK Investigational Site
Potsdam, Brandenburg, Germany, 14469
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 10717
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 10965
GSK Investigational Site
Berlin, Germany, 12165
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Berlin, Germany, 13187
Greece
GSK Investigational Site
Kavala, Greece, 65403
GSK Investigational Site
Larissa, Greece, 41110
GSK Investigational Site
N. Efkarpia, Thessaloniki, Greece, 564 29
GSK Investigational Site
Papagos, Athens, Greece, 156 69
GSK Investigational Site
Rethymnon, Crete, Greece, 74100
GSK Investigational Site
Thessaloniki, Greece, 57010
Korea, Republic of
GSK Investigational Site
Bucheon-Si,, Korea, Republic of
GSK Investigational Site
Cheongju, Chungcheongbuk-do, Korea, Republic of, 361-711
GSK Investigational Site
Gwangju, Korea, Republic of, 501-757
GSK Investigational Site
Seoul,, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Suwon, Kyonggi-do, Korea, Republic of, 443-721
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44100
GSK Investigational Site
Zapopan, Jalisco, Mexico, 45040
Philippines
GSK Investigational Site
Quezon City, Philippines, 1100
GSK Investigational Site
Quezon City, Philippines, 1101
GSK Investigational Site
Quezon City, Philippines, 1109
GSK Investigational Site
Quezon City, Philippines
Poland
GSK Investigational Site
Gdansk, Poland, 80-952
GSK Investigational Site
Warszawa, Poland, 01-184
GSK Investigational Site
Wroclaw, Poland, 50-445
Romania
GSK Investigational Site
Bucharest, Romania, 011607
GSK Investigational Site
Bucuresti, Romania
GSK Investigational Site
Deva, Romania, 330084
GSK Investigational Site
Targu Mures, Romania, 540143
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105 077
GSK Investigational Site
Moscow, Russian Federation, 109240
GSK Investigational Site
Moscow, Russian Federation, 115 280
GSK Investigational Site
Moscow, Russian Federation, 129010
GSK Investigational Site
Smolensk, Russian Federation, 214001
GSK Investigational Site
Tomsk, Russian Federation, 634001
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 826 06
GSK Investigational Site
Trencin, Slovakia, 911 08
South Africa
GSK Investigational Site
Amanzimtoti, South Africa, 4126
GSK Investigational Site
Bloemfontein, South Africa, 9300
GSK Investigational Site
Cape Town, South Africa, 7500
GSK Investigational Site
Claremont, South Africa, 7708
GSK Investigational Site
Mowbray, South Africa, 7700
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFA109685
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFA109685
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFA109685
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFA109685
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFA109685
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFA109685
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFA109685
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00603278     History of Changes
Other Study ID Numbers: FFA109685 
Study First Received: December 27, 2007
Results First Received: June 6, 2013
Last Updated: November 4, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Adolescents
Adults
Pharmacokinetics
Asthma
GW685698X
Pharmacogenetics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 20, 2017