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AzTrials

AsthmaPhase 2NCT00603746

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

A Phase 2 study testing GW685698X in people with Asthma, run by GlaxoSmithKline at 154 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
GW685698X
Could I receive a placebo?
No, everyone receives an active treatment
How many people
627 participants
Where
154 sitesin 16 countries
Study dates
1 Dec 2007to 20 Sep 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 3. 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
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  • 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%-85% of the predicted normal value during the morning Visit 1 screening period or a best FEV1 of 40%-90% of the predicted normal value during the evening Visit 1 screening period.
  • 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 during the screening period.
  • Re-screening of subjects during the Visit 1 screening period: If a subject does not meet the inclusion criteria based upon FEV1 percent predicted and/or reversibility, the subject may return to the site once within 4 days and repeat the lung function tests.
  • 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 >176 ≤ 440mcg exactuator or > 200 ≤500mcg ex valve]; [fluticasone propionate DPI > 200≤500mcg]; [beclomethasone dipropionate DPI > 420 ≤ 840mcg exactuator or > 500 ≤ 1000mcg ex-valve]; [beclomethasone dipropionate HFA Qvar > 160 ≤ 480mcg exactuator or > 200 ≤ 500mcg ex-valve]; [budesonide DPI MDI >400 ≤1200mcg]; [flunisolide > 1000 ≤ 2000mcg]; [triamcinolone acetonide >1000 ≤1600mcg]; [mometasone furoate DPI >200 ≤ 440mcg]; [ciclesonide MDI HFA >160 mcg ≤ 320mcg ex-actuator dose / >200mcg ≤ 400mcg 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.
  • 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:
  • Evening pre-dose percent predicted FEV1 of between 40% and 90% of their predicted normal.
  • 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).

Who cannot join

  • 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 subject's asthma status or the subject's 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.
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  • 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.
  • 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.
  • Changes in asthma medication (excluding albuterol/salbutamol inhalation aerosol provided at Visit 1).
  • 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 subject's asthma status or the subject's ability to participate in the study.
  • 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.
  • 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).
  • 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.

Trial locations and contacts

154 sites in 16 countries.

154 sites in 16 countries

United States94 sites

  • GSK Investigational Site

    Bangor, Maine, 04401

  • GSK Investigational Site

    Bellingham, Washington, 98225

  • GSK Investigational Site

    Billings, Montana, 59101

  • GSK Investigational Site

    Bloomingdale, Illinois, 60108

  • GSK Investigational Site

    Bluffton, South Carolina, 29910

  • GSK Investigational Site

    Boca Raton, Florida, 33487

  • GSK Investigational Site

    Boerne, Texas, 78006

  • GSK Investigational Site

    Bridgeport, Connecticut, 06606

  • GSK Investigational Site

    Butte, Montana, 59701

  • GSK Investigational Site

    Canton, Ohio, 44718

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Chicago, Illinois, 60617

  • GSK Investigational Site

    Cincinnati, Ohio, 45231

  • GSK Investigational Site

    Cleveland, Ohio, 44113

  • GSK Investigational Site

    Clifton, New Jersey, 7011

  • GSK Investigational Site

    Cocoa, Florida, 32927

  • GSK Investigational Site

    Colorado Springs, Colorado, 80910

  • GSK Investigational Site

    Columbus, Ohio, 43235

  • GSK Investigational Site

    Crescent Springs, Kentucky, 41017

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Daytona Beach, Florida, 32114

  • GSK Investigational Site

    DeKalb, Illinois, 60115

  • GSK Investigational Site

    Detroit, Michigan, 48221

  • GSK Investigational Site

    Dickinson, Texas, 77539

  • GSK Investigational Site

    East Syracuse, New York, 13057

  • GSK Investigational Site

    Eugene, Oregon, 97401

  • GSK Investigational Site

    Evansville, Indiana, 47713

  • GSK Investigational Site

    Fort Smith, Arkansas, 72903

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gainesville, Georgia, 30501

  • GSK Investigational Site

    Granada Hills, California, 91344

  • GSK Investigational Site

    Greensboro, North Carolina, 27408

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Gurnee, Illinois, 60031

  • GSK Investigational Site

    Hillsborough, New Jersey, 08844

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Iowa City, Iowa, 52240

  • GSK Investigational Site

    Ithaca, New York, 14850

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Knoxville, Tennessee, 37909

  • GSK Investigational Site

    Largo, Florida, 33770

  • GSK Investigational Site

    Las Vegas, Nevada, 89107

  • GSK Investigational Site

    Lenexa, Kansas, 66215

  • GSK Investigational Site

    Little Rock, Arkansas, 72211-3733

  • GSK Investigational Site

    Little Silver, New Jersey, 07739

  • GSK Investigational Site

    Long Beach, California, 90806

  • GSK Investigational Site

    Long Beach, California, 90808

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Los Angeles, California, 90095-1752

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Metairie, Louisiana, 70002

  • GSK Investigational Site

    Miami, Florida, 33157

  • GSK Investigational Site

    Miami, Florida, 33175

  • GSK Investigational Site

    Missoula, Montana, 59808

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120

  • GSK Investigational Site

    Palmdale, California, 93551

  • GSK Investigational Site

    Phoenix, Arizona, 85028

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • GSK Investigational Site

    Plano, Texas, 75093

  • GSK Investigational Site

    Raleigh, North Carolina, 27607

  • GSK Investigational Site

    Riverside, California, 92506

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    Rockville Centre, New York, 11570

  • GSK Investigational Site

    Rolla, Missouri, 65401

  • GSK Investigational Site

    Roseville, California, 95678

  • GSK Investigational Site

    San Antonio, Texas, 78205

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78233

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    Skillman, New Jersey, 08558

  • GSK Investigational Site

    South Burlington, Vermont, 05403

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    Spokane, Washington, 99207

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    St Louis, Missouri, 63143

  • GSK Investigational Site

    Tampa, Florida, 33613

  • GSK Investigational Site

    Taylor, Michigan, 48180

  • GSK Investigational Site

    Torrance, California, 90505

  • GSK Investigational Site

    Waco, Texas, 76712

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Warrensburg, Missouri, 64093

  • GSK Investigational Site

    Waterbury, Connecticut, 06708

  • GSK Investigational Site

    West Covina, California, 91790

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Winter Park, Florida, 32789

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada9 sites

  • GSK Investigational Site

    Ajax, Ontario, L1S 2J5

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Brampton, Ontario, L6T 3T1

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4G2

  • GSK Investigational Site

    Québec, Quebec, G1V 4M6

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

Other trials in Canada

Germany5 sites

  • GSK Investigational Site

    Berlin, 10367

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 13597

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Hanover, Lower Saxony, 30167

Other trials in Germany

Mexico5 sites

  • GSK Investigational Site

    Distrito Federal, 06760

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    México, 04530

  • GSK Investigational Site

    México, 11550

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

Netherlands5 sites

  • GSK Investigational Site

    Amsterdam, 1034 CS

  • GSK Investigational Site

    Eindhoven, 5623 EJ

  • GSK Investigational Site

    Hengelo, 7555 DL

  • GSK Investigational Site

    Schiedam, 3116 BA

  • GSK Investigational Site

    Utrecht, 3584 EA

Other trials in Netherlands

Russia5 sites

  • GSK Investigational Site

    Irkutsk, 664005

  • GSK Investigational Site

    Kazan', 420015

  • GSK Investigational Site

    Moscow, 115 280

  • GSK Investigational Site

    Moscow, 123367

  • GSK Investigational Site

    Tomsk, 634001

Other trials in Russia

Chile4 sites

  • GSK Investigational Site

    Puente Alto - Santiago, Región Metro de Santiago, 8207257

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500551

  • GSK Investigational Site

    Santiago, 8380453

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

Czechia4 sites

  • GSK Investigational Site

    Beroun, 266 01

  • GSK Investigational Site

    Brno, 639 00

  • GSK Investigational Site

    Kutná Hora, 284 01

  • GSK Investigational Site

    Tábor

Other trials in Czechia

France4 sites

  • GSK Investigational Site

    Grenoble, 38000

  • GSK Investigational Site

    Marseille, 13009

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nantes, 44093

Other trials in France

South Africa4 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    eManzimtoti, 4126

  • GSK Investigational Site

    Mowbray, 7700

Other trials in South Africa

Australia3 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Clayton, Victoria, 3168

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

Other trials in Australia

Bulgaria3 sites

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sofia, 1431

Other trials in Bulgaria

Poland3 sites

  • GSK Investigational Site

    Bialystok, 15-276

  • GSK Investigational Site

    Warsaw, 02-097

  • GSK Investigational Site

    Wroclaw, 50-434

Other trials in Poland

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13619

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Peru2 sites

  • GSK Investigational Site

    Lima, Lima 1

  • GSK Investigational Site

    Lima, Lima 27

Other trials in Peru

Thailand2 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

Other trials in Thailand

About this study

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 500mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent an

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

Read the 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 Moderate-Dose ICS Therapy

Conditions
Asthma
Being tested
GW685698X
Keywords
Adolescents, Adults, Asthma, Pharmacokinetics, Pharmacogenetics, GW685698X
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW685698XDrug

    GW685698X

Study groups in NCT00603746
Study groupRoleWhat they receive
GW685698XExperimentalGW685698X
Receives: Drug: GW685698X

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8

    Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs 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.

    Measured: Baseline and Week 8

Secondary outcomes (22)

  1. 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

    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. 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.

    Measured: From Baseline up to Week 8

  2. Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period

    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough PEF is defined as the maximal rate (speed) that a person can exhale during a short maximal expiratory effort after a full inspiration. 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.

    Measured: From Baseline up to Week 8

  3. Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period

    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.

    Measured: From Baseline up to Week 8

  4. Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 8-week Treatment Period

    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-hour 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.

    Measured: From Baseline up to Week 8

  5. Number Participants Who Withdrew Due to Lack of Efficacy During the 8-week Treatment Period

    The number of participants whose primary reason for withdrawal was lack of efficacy was analyzed.

    Measured: From the first dose of the study medication up to Week 8/Early Withdrawal

  6. Number of Participants With Any On-treatment Adverse Event or Serious Adverse Event Throughout the 8-week Treatment Period

    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.

    Measured: From the first dose of the study medication up to Week 8/Early Withdrawal

  7. Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis

    A detailed oropharyngeal examination for visual evidence of oral candidiasis was performed.

    Measured: From Baseline up to Week 8/Early Withdrawal

  8. Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8

    Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in the blood at Baseline (BL) and Week 8 (W8). The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  9. Hematocrit at Baseline and Week 8

    Blood samples were collected for the measurement of hematocrit at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  10. Hemoglobin at Baseline and Week 8

    Blood samples were collected for the measurement of hemoglobin at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  11. Platelet Count and White Blood Cell Count at Baseline and Week 8

    Blood samples were collected for determining the platelet count and white blood cell (WBC) count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  12. Red Blood Cell Count at Baseline and Week 8

    Blood samples were collected for determining the red blood cell count at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit1).

    Measured: Baseline and Week 8

  13. Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LDH) at Baseline and Week 8

    Blood samples were collected for the measurement of ALT, ALP, AST, GGT, and LDH at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  14. Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8

    Blood samples were collected for the measurement of albumin and total protein at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  15. Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Phosphorus Inorganic, Potassium, Sodium, and Urea at Baseline and Week 8

    Blood samples were collected for the measurement of calcium, carbon dioxide content/bicarbonate (CO2/BI), chloride, cholesterol, glucose, phosphorus inorganic (PI), potassium, sodium, and urea at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  16. Clinical Chemistry Parameters of Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid at Baseline and Week 8

    Blood samples were collected for the measurement of creatinine, direct bilirubin (DBIL), total bilirubin (TBIL), and uric acid at Baseline and Week 8. The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8

  17. Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/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 Cells (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; results for urinalysis parameters can be read as 1+, 2+, 3+, Large, Moderate, Negative (Neg), Small, and Trace. 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, 2+ or 1/2 G/dL, 3+ or 1 G/dL, 4+ or 2 or more G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had 1+, 2+, 3+, Large, Moderate, Neg, Small, or Trace levels at Baseline (BL) and Week 8 (W8)/Early Withdrawal (EW). The Baseline value was the measurement taken at screening (Visit 1).

    Measured: Baseline and Week 8/Early Withdrawal

  18. 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.

    Measured: Baseline and Week 8/Early Withdrawal

  19. Urine pH at 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).

    Measured: Baseline and Week 8/Early Withdrawal

  20. 24-hour Urinary Cortisol Excretion at 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.

    Measured: Baseline and Week 8

  21. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8

    Change from Baseline was calculated as the Week 8 value minus the Baseline value.

    Measured: Baseline and Week 8

  22. Change From Baseline in Heart Rate at Week 8

    Change from Baseline was calculated as the Week 8 value minus the Baseline value.

    Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2008 (estimated)
  2. Study start1 Dec 2007
  3. Primary completion1 Sep 2008
  4. Study completion20 Sep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
627 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00603746
Sponsor's protocol ID
FFA109684
Status last verified
Aug 2017
First submitted
27 Dec 2007
Last updated
15 Sep 2017
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Busse WW, Bleecker ER, Bateman ED, Lotvall J, Forth R, Davis AM, Jacques L, Haumann B, Woodcock A. Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trial. Thorax. 2012 Jan;67(1):35-41. doi: 10.1136/thoraxjnl-2011-200308. Epub 2011 Aug 9.

    PubMed 21828231

  • O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.

    PubMed 27881132

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW685698X in people with Asthma, run by GlaxoSmithKline at 154 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, Canada, Germany, Mexico, Netherlands and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603746, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.

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Clinical Trial NCT00603746 | AzTrials