Исследования / № 00398645
|Краткое название||A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Persistent Asthma.|
|Полное название||See Detailed Description|
|Под контролем||United States: Food and Drug Administration|
Australia: Department of Health and Ageing Therapeutic Goods Administration
|Краткое описание||This study is designed to determine if the investigational drug is effective and safe in|
individuals with asthma.
|Дата начала||November 2006|
|Подробное описание||A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to|
Evaluate the Efficacy and Safety of GW685698X 200mcg Twice Daily, GW685698X 200mcg and
400mcg Once Daily in the Morning, and GW685698X 200mcg and 400mcg Once Daily in the Evening
Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects (12 Years of Age and
Older) with Persistent Asthma.
|Вид исследования||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment|
- Type of Subject: Outpatient
- Age: 12 years of age or older at Visit 1 (or ??18 years of age or older if local
regulations or the regulatory status of study medication permit enrollment of adults
- Gender: Male or eligible female - Females are eligible to participate only if they
are currently non-pregnant and non-lactating. 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, Double-barrier method - spermicide plus a mechanical barrier (e.g.,
spermicide plus a male condom or a spermicide and female diaphragm), The
contraceptive transdermal patch, Ortho Evra (if the subject is less than 198 pounds),
Female subjects should not be enrolled if they plan to become pregnant during the
time of study participation. A urine pregnancy test is required for all subjects at
all visits, Female subjects should not be enrolled if they plan to become pregnant
during the time of study participation. A urine pregnancy test is required for all
subjects at all visits, Female subjects should not be enrolled if they plan to
become pregnant during the time of study participation. A urine pregnancy test is
required for all subjects at all visits, 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),
- Asthma Diagnosis: Asthma as defined by the National Institutes of Health [National
Institutes of Health, 2002; GINA, 2005].
- Severity of Disease: A best AM FEV1 of 50% to 80% of the predicted value during
Visit 1 based on the "Standardization of Lung Function Tests" [European Respiratory
Society, 1993] standards for 18 years and older or Polgar [Polgar, 1971] standards
for 12 to 17 years and race adjusted for African-Americans [American Thoracic
- Reversibility of Disease: Demonstrated ??12% and 200mL reversibility of FEV1 within
30 minutes following 200 to 400mcg of albuterol/salbutamol inhalation aerosol (or one
nebulized albuterol/salbutamol treatment) at Visit 1. If a subject fails to
demonstrate an increase in FEV1 of ??12% and 200mL, the subject is not eligible for
the study and will not be allowed to re-screen.
- Concurrent Anti-Asthma Therapy: Subjects must be using an inhaled corticosteroid for
at least 3 months prior to Visit 1 and be maintained on a stable dose for four weeks
prior to Visit 1 at one of the following doses: Anti-Asthma Therapy Maximum Daily
Dose (mcg/day) Fluticasone propionate MDI CFC/HFA ?‰¤220mcg1/?‰?250mcg2 Fluticasone
propionate DPI 200mcg Beclomethasone dipropionate 420mcg1/500mcg2 Beclomethasone
dipropionate HFA 160mcg1/200mcg2 Budesonide DPI 400mcg Flunisolide 1000mcg
Triamcinolone acetonide 1000mcg Mometasone furoate 200mcg Ciclesonide 160mcg1/200mcg2
1. Ex-actuator dose: dose delivered to the lungs
2. Ex-valve dose: dose expressed from the valve
- Short-Acting Beta2-Agonist: All subjects must be able to replace short-acting
beta2-agonists with albuterol/salbutamol inhalation aerosol at Visit 1 for use
as-needed for the duration of the study. Subjects must be able to withhold all
inhaled short-acting beta-sympathomimetic bronchodilators for at least 6 hours prior
to study visits.Note: Nebulized albuterol/salbutamol will not be allowed during the
study with the exception of its use during reversibility testing at Visit 1. The use
of albuterol/salbutamol through the DISKUS/ACCUHALER device will not be allowed
during the study.
- 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 all the study requirements.
- History of Life-Threatening Asthma: History of life-threatening asthma, defined as
an asthma episode that required intubation and/or was associated with hypercapnia,
respiratory arrest or hypoxic seizures.
- Anti-Asthma Medications: Asthma medications listed below must not have been used
prior to Visit 1 for the required interval listed below, and not taken during the
study: Within 24 hours of Visit 1: Oral short-acting beta2-agonists: Within 2 weeks
of Visit 1:Combination therapy containing inhaled beta2-agonists and ICS for asthma
(e.g., fluticasone propionate/salmeterol combination, budesonide/formoterol
combination);Slow-release bronchodilators (e.g., aminophylline,
theophylline);Anticholinergics; Long-acting beta2-agonists (e.g., salmeterol);
Ketotifen; Nedocromil sodium; Sodium cromoglycate; Oral long-acting beta2-agonists.
Within 4 weeks of Visit 1: Anti-leukotrienes including suppressors of leukotriene
production and antagonists. Within 12 weeks of Visit 1: Systemic, oral, parenteral,
or depot corticosteroids; Anti-IgE (e.g., omalizumab).
- Other Medications: The medications listed below must not have been used prior to
Visit 1 for the required interval indicated below, and not taken during the study:
Within 4 weeks of Visit 1: Known potent inhibitors of CYP3A4 (e.g., ritonavir,
- Respiratory Infection: History of a respiratory tract infection within 4 weeks of
Visit 1. In addition, the subject must be excluded, if such infection occurs between
Visits 1 and 2.
- Asthma Exacerbation: History of a an asthma exacerbation within 4 weeks of Visit 1,
any asthma exacerbation requiring oral corticosteroids within 3 months of Visit 1, or
any hospitalization due to asthma exacerbation within 6 months of Visit 1.
- Investigational Medications: A subject must not have used any investigational drug
within 30 days prior to Visit 1 or within ten half-lives (t1/2) of the prior
investigational study (which ever is longer of the two) or concurrently during the
- Concurrent Diseases/Abnormalities: Historical or current evidence of clinically
significant uncontrolled disease including, but not limited to: cardiovascular
disease, malignancy, 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.
- Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she
has evidence of oropharyngeal candidiasis at Visit 1.
- Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity
to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic
- 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 it was initiated prior to Visit 1 and the subject is maintained on a stable daily
dose 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 compliance with study
medication or procedures (e.g., completion of daily diary). Neurological or
psychiatric disease or history of drug or alcohol abuse which would interfere with
the subject's proper completion of the protocol requirements excludes study
- Tobacco Use: A subject may not have used tobacco products within the past one year
(i.e., cigarettes, cigars, or pipe tobacco) and must not have historical use of >10
pack years (e.g., 20 cigarettes/day for 10 years).
- 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.
|Минимальный возраст||12 Years|
|Drug||GW685698X 200mcg,GW685698X 200mcg and 400mcg|
|Контакты и расположение|
|Donetsk , 83099||GSK Investigational Site|
|Kiev , 01601||GSK Investigational Site|
|Kiev , 01004||GSK Investigational Site|
|Kiev , 03680||GSK Investigational Site|
|Kyiv , 02091||GSK Investigational Site|
|Vinnitsa , 21021||GSK Investigational Site|