EUCTR2010-019589-10-NL进行中（未招募）1 期
A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,564
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: Outsubjects 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) 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.
- •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, etonogestrel
- •Injectable progestogen
- •Oral contraceptive (either combined oestrogen/progestin or progestin only)
- •Any intrauterine device (IUD) with a documented failure rate of less than 1%
- •Double barrier method–spermacide plus a mechanical barrier (e.g.,
- •spermacide plus a male condom or a spermacide and female diaphragm).
- •Oestrogenic vaginal ring
- •Percutaneous contraceptive patches
- •Females of childbearing potential who are not sexually active must commit to
- •complete abstinence from intercourse throughout the clinical study and for a
- •period after the study 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 6 or early withdrawal. In addition, a urine pregnancy test will
- •be performed on all females of childbearing potential at Visit 2
- •(Randomisation). Subjects will be given a home urine pregnancy kit for use
- •during the follow-up period.
- •4. Severity of Disease: A best evening pre-bronchodilator FEV1 of =40%- and =85%
- •of the predicted normal value. Predicted values will be based upon NHANES III
- •[Hankinson, 1999]. 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 [Hankinson, 2010]. Otherwise, the
- •Caucasian equations will be used.
- •5. Reversibility of Disease: Demonstrated a =12% and =200ml reversibility of FEV1
- •within 10-40-minutes following 2-4 inhalations of salbutamol/albuterol inhalation
- •aerosol or equivalent dose of nebulised salbutamol/albuterol at the Screening Visit.
- •6. Current Anti-Asthma Therapy: Subjects must have been using an inhaled
- •corticosteroid for at least 12 weeks prior to Visit 1 and be maintained on a medium
- •dose (e.g. FP 250 mcg twice daily) for at least 4 weeks prior to Visit 1view protocol for further information.
- •7. Short-Acting Beta2-Agonists: All subjects must be able to replace their current
- •short-acting beta2-agonists with salbutamol/albuterol inhaler at Visit 1 for use as
- •needed for the duration of the study. Subjects must be able to withhold
- •salbutamol/albuterol for at least 6 hours prior to lung function assessments.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Numbe
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 hypercapnoea, respiratory arrest or hypoxic seizures within the last 5 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 prior to 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 hospitalisation requiring additional treatment for asthma within 12 weeks 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 subjects must not have any
- •clinically significant, uncontrolled condition or disease state that, in the opinion of
- •the investigator, would put the safety of the subject at risk through study
- •participation or would confound the interpretation of the efficacy results if the
- •condition/disease exacerbated during the study view page 18 of the protocol for futher 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 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 novel dry powder inhaler or
- •ACCUHALER™/DISKUS™ (i.e., lactose or magnesium stearate).
- •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, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants; beta-adrenergic blocking agents; phenothiazines and monoamine oxidase (MAO) inhibitors.
- •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.
- •11. Tobacco Use: Current smoker or with a sm
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