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临床试验/EUCTR2010-020144-34-DE
EUCTR2010-020144-34-DE进行中（未招募）不适用

A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of fluticasone furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 330 人开始时间: 2010年12月14日最近更新:
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适应症
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
330
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

性别
All

入选标准

  • •1. Informed consent: Subjects must give their signed and dated written informed consent to participate
  • •2. Type of Subject: Outpatients 12 years of age or older at Visit 1 (or =18 years of age if local regulations or the regulatory status of study medication permit enrolment of adults only; in Germany: =18 years of age) with a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2007] at least 12 weeks prior to Visit 1.
  • •3. Gender: Male or Eligible Female, defined as non-childbearing potential or
  • •childbearing potential using an acceptable method of birth control consistently and
  • •correctly, 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, etonogestrel
  • •Injectable progestogen
  • •Oral contraceptive (either combined estrogen/progestin or progestin only)
  • •Any intrauterine device (IUD) with a documented failure rate of less than 1%
  • •Double barrier method – spermicide plus a mechanical barrier (e.g., spermicide
  • •plus a male condom or a spermicide and female diaphragm).
  • •Estrogenic vaginal ring
  • •Percutaneous contraceptive patches
  • •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
  • •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 for females of childbearing potential at the initial screening visit
  • •(Visit 1) and Visit 9 or Early Withdrawal. In addition a urine pregnancy test
  • •will be performed on all females of childbearing potential at Visits 2 and 6 and a
  • •take-home test will be performed at Visit 10 (Follow up Visit/Contact).
  • •4. Severity of Disease: A best pre-bronchodilator FEV1 of 40%-90% of the predicted
  • •normal value at the Visit 1 screening visit. Predicted values will be based upon
  • •NHANES III [Hankinson, 2010]. If a subject is recorded as having Hispanic or
  • •Latino ethnicity, then the Mexican-American equations will be used (irrespective of
  • •race). If a subject is recorded as being of African-American/African heritage race,
  • •then the African-American equations will be used. If a subject is recorded as being of
  • •Asian race, then the Asian adjustment will be used. Otherwise, the Caucasian
  • •equations will be used.
  • •5. Reversibility of Disease: Demonstrated =12% and =200mL evening reversibility of
  • •FEV1 within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol
  • •inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol
  • •solution) at screening (Visit 1).
  • •6. Current Anti-Asthma Therapy: Subjects must be taking a stable doses of ICS for at least 4
  • •weeks prior to Visit 1.
  • •See Table 1 Page 18 of the protocol for examples of doses of commonly prescribed ICS medication.
  • •7. Short-Acting Beta2-Agonists (SABAs): All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit1 for use as
  • •needed for the duration of the study. Subjects must be able to withhold
  • •albuterol/salbutamol for at least 6 hours prior to study visits.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjec

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 within the last 10 years.
  • •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 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.
  • •3. Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids or
  • •that resulted in overnight hospitalization requiring additional treatment for asthma
  • •within 6 months prior to Visit 1.
  • •4. Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease,
  • •bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive
  • •pulmonary disease, or other respiratory abnormalities other than asthma.
  • •5. Other Concurrent Diseases/Abnormalities: A subject must not have any clinically
  • •significant, uncontrolled condition or disease state that, in the opinion of the
  • •investigator, would put the safety of the patient at risk through study participation or
  • •would confound the interpretation of the efficacy results if the condition/disease
  • •exacerbated during the study. View protocol for further information.
  • •6. Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she
  • •has clinical visual evidence of candidiasis at Visit 1.
  • •7. Investigational Medications: A subject must not have used any investigational
  • •drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior
  • •investigational study (whichever is the longer of the two).
  • •8. Allergies:
  • •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 new powder inhaler (i.e., lactose).
  • •Milk Protein Allergy: History of severe milk protein allergy.
  • •9. Concomitant Medication:
  • •Administration of prescription or over the counter medication that would
  • •significantly affect the course of asthma, or interact with study drug.
  • •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 it was initiated 4 weeks prior to Visit 1 and subjects remain in the
  • •maintenance phase for the duration of the study.
  • •Cytochrome P450 3A4 (CYP3A4) inhibitors: Subjects who have received a
  • •potent CYP3A4 inhibitor within 4 weeks of Visit 1(e.g., ritonavir, ketoconazole,
  • •itraconzole).
  • •10. Compliance: A subject will not be eligible if he/she or his/her parent or legal
  • •guardian has any infirmity, disability, disease, or geographical location which seems
  • •likely (in the opinion of the Investigator) to impair compliance with any aspect of
  • •this study protocol, including visit schedule and completion of the daily diaries.
  • •11. Tobacco Use: Current smoker or a smoking history of 10 pack years (e.g., 20
  • •cigarettes/day for 10 years). A subject may not have used inhaled tobacco products
  • •within the past 3 months (i.e., cigarettes, cigar

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