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 and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy.

GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 1,175 人开始时间: 2007年12月6日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 1,175

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

入选标准

•Subjects eligible for enrolment in the study must meet all of the following criteria:
•1. Type of Subject: Outpatient
•2. 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
•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 – spermacide plus a mechanical barrier (e.g., spermacide plus a male condom or a spermacide 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.
•4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health
•[National Institutes of Health (NIH), 2007].
•5. Severity of Disease: A best FEV1 of 40%-90% of the predicted normal value during
•Visit 1. NHANES III predicted values will be used for subjects aged = 12 years and
•adjustments to predicted values will be made for African American subjects.
•[Hankinson, 1999].
•6. Reversibility of Disease: Demonstrated a = 12% and =200mL reversibility of FEV1
•within 30-minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol
•(if required, spacers are permitted for reversibility testing only) or one nebulized
•albuterol/salbutamol solution at the Screening Visit. If a subject fails to demonstrate
•an increase in FEV1 =12% and =200mL, then the subject is not eligible for the study
•and will not be

排除标准

•1. History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
•2. 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. In addition, the subject must be excluded if such infection occurs between Visits 1 and 3.
•3. 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.
•4.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. Further excluded conditions/diseases are listed in section 4.3 of the protocol.
•5. 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.
•6.Investigational Medications: A subject must not have used any investigational drug within 30 days prior to Visit 1.
•7. 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).
•8. Milk Protein Allergy: History of severe milk protein allergy.
•9. Immunosuppressive Medications: A subject must not be using, or require use, of immunosuppressive medications during the study. (Note: Immunotherapy for asthma allowed provided initiated prior to visit 1 and the subject is maintained on a stable regimen throughout the study period).
•10. 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.
•11. Tobacco Use. Current smoker or a smoking history of 10 pack years or mor

研究者

发起方

GlaxoSmithKline Research and Development Ltd

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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 and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy.-J45J45

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