AzTrials
AzTrials

AsthmaPhase 2NCT00603382

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

A Phase 2 study testing GW685698X in people with Asthma, run by GlaxoSmithKline at 149 sites in 14 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?
Yes, some participants may receive a placebo
How many people
599 participants
Where
149 sitesin 14 countries
Study dates
1 Dec 2007to 2 Oct 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 enrollment 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 enrollment 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
Show all 26Show fewer
  • 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 (spacers are permitted for reversibility testing if required) or one nebulized albuterol/salbutamol solution at 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 non-corticosteroid controller or short acting beta2-agonist bronchodilators alone (with no inhaled corticosteroids use for at least 6 weeks) for ≥ 3 months preceding Visit 1.
  • 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 before 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 heart 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 hypertension1, hematological, hepatic, or renal disease, current malignancy2, cushings disease, uncontrolled diabetes mellitus, recent history of drug or alcohol abuse.
  • systolic blood pressure ≥160, or diastolic blood pressure >100
  • history of malignancy is acceptable only if subject has been in remission for one year prior to Visit 1 (remission = no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to Visit 1)
Show all 29Show fewer
  • Patients with a history of tuberculosis who have received an approved prophylactic treatment regimen or an approved active treatment regimen and who have had no evidence of active disease for a minimum of 2 years may be enrolled [American Thoracic Society, 2003; American Thoracic Society, 2005]"
  • 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.
  • Administration of inhaled corticosteroids within 6 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 an 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

149 sites in 14 countries.

149 sites in 14 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, 29406

  • GSK Investigational Site

    Charleston, South Carolina, 29414

  • 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

    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

  • GSK Investigational Site

    Manassas, Virginia, 20110

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Metairie, Louisiana, 70002

  • GSK Investigational Site

    Miami, Florida, 33126

  • GSK Investigational Site

    Miami, Florida, 33157

  • GSK Investigational Site

    Missoula, Montana, 59808

  • 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

    Red Bank, New Jersey, 07701

  • 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

Canada11 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

    Saskatoon, Saskatchewan, S7K 7H9

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • GSK Investigational Site

    Toronto, Ontario, M3H 5S4

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

Other trials in Canada

France6 sites

  • GSK Investigational Site

    Évreux, 27000

  • GSK Investigational Site

    Montbrison, 42600

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Toulon, 83000

  • GSK Investigational Site

    Toulouse, 31300

  • GSK Investigational Site

    Vieux-Condé, 59690

Other trials in France

Germany6 sites

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 10965

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Marburg, Hesse, 35037

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

  • GSK Investigational Site

    Sinsheim, Baden-Wurttemberg, 74889

Other trials in Germany

South Korea6 sites

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Cheongju, Chungcheongbuk-do, 361-711

  • GSK Investigational Site

    Gwangju, 501-757

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Russia5 sites

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Novokuznetsk, 654063

  • GSK Investigational Site

    Samara, 443079

  • GSK Investigational Site

    Smolensk, 214 019

  • GSK Investigational Site

    Yaroslavl, 150003

Other trials in Russia

Bulgaria4 sites

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Sofia, 1202

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

Mexico3 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44100

  • GSK Investigational Site

    Monterrey N.L, Nuevo León, 64988

  • GSK Investigational Site

    Zapopan, Jalisco, 45040

Other trials in Mexico

Philippines3 sites

  • GSK Investigational Site

    Cavite, 4114

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Manila, 1000

Other trials in Philippines

Slovakia3 sites

  • GSK Investigational Site

    Banská Bystrica, 975 17

  • GSK Investigational Site

    Bratislava, 841 08

  • GSK Investigational Site

    Martin, 036 59

Other trials in Slovakia

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13419

  • 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

Poland2 sites

  • GSK Investigational Site

    Lodz, 90-153

  • GSK Investigational Site

    Zawadzkie, 47-120

Other trials in Poland

Sweden2 sites

  • GSK Investigational Site

    Boden, SE-961 64

  • GSK Investigational Site

    Luleå, SE-971 89

Other trials in Sweden

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 Administered Once Daily and Fluticasone Propionate Inhalation Powder 100mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Non-Steroidal, Asthma Therapy

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 Non-Steroidal, Asthma Therapy

Conditions
Asthma
Being tested
GW685698X, Placebo
Keywords
Adults, Pharmacokinetics, Pharmacogenetics, Asthma, Adolescents, 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

  • PlaceboDrug

    placebo comparator

Study groups in NCT00603382
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
GW685698XExperimentalNot described
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 forcefully 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 through Week 8 clinic visits. Trough FEV1 is the FEV1 measured approximately 24 hours after the last administration of study drug. 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 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.

    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 PEF measurement performed at th 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.

    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 of 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 study medication up to Week 8/Early Withdrawal

  6. Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events 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 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 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).

    Measured: Baseline and Week 8

  9. Hematocrit at 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).

    Measured: Baseline and Week 8

  10. Hemoglobin at 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).

    Measured: Baseline and Week 8

  11. Platelet Count and White Blood Cell (WBC) Count at 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).

    Measured: Baseline and Week 8

  12. Red Blood Cells (RBC) Count at 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).

    Measured: Baseline and Week 8

  13. 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

    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).

    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 (BL) and Week 8 (W8). The Baseline value was the measurement taken at Screening (Visit 1).

    Measured: Baseline and Week 8

  15. 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

    Blood samples were collected for the measurement of chloride, calcium, CO2/BI, cholesterol, glucose, PI, potassium, sodium, and urea/blood urea nitrogen at Baseline (BL) and Week 8 (W8). 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/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 large, moderate (Mod), negative (Neg), small, Trace, 1+, 2+, 3+ and 4+, and for UG the result can be read as Neg, Trace, Trace or 1/10 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 (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 hr urinary cortisol excretion at the following scheduled time points: within 7 days prior to Study Visits 3 (Week 0) and Visit 8 (Week 8). The Baseline value for 24 hr 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 Oct 2008
  4. Study completion2 Oct 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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
599 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00603382
Sponsor's protocol ID
FFA109687
Status last verified
Mar 2018
First submitted
27 Dec 2007
Last updated
18 Apr 2018
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

  • Bateman ED, Bleecker ER, Lotvall J, Woodcock A, Forth R, Medley H, Davis AM, Jacques L, Haumann B, Busse WW. Dose effect of once-daily fluticasone furoate in persistent asthma: a randomized trial. Respir Med. 2012 May;106(5):642-50. doi: 10.1016/j.rmed.2012.01.004. Epub 2012 Feb 18.

    PubMed 22342538

  • Psaila B, Bussel JB, Linden MD, Babula B, Li Y, Barnard MR, Tate C, Mathur K, Frelinger AL, Michelson AD. In vivo effects of eltrombopag on platelet function in immune thrombocytopenia: no evidence of platelet activation. Blood. 2012 Apr 26;119(17):4066-72. doi: 10.1182/blood-2011-11-393900. Epub 2012 Jan 31.

    PubMed 22294727

  • 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

  • Gross AS, Goldfrad C, Hozawa S, James MH, Clifton CS, Sugiyama Y, Jacques L. Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials. BMC Pulm Med. 2015 Dec 24;15:165. doi: 10.1186/s12890-015-0159-z.

    PubMed 26704701

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW685698X in people with Asthma, run by GlaxoSmithKline at 149 sites in 14 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 26 inclusion and 29 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Canada, France, Germany, South Korea and 9 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. Some participants in this study may receive a placebo. 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 NCT00603382, which also lists 4 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 18 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in