EUCTR2010-019594-14-DE进行中（未招募）不适用
A randomised, double-blind, parallel group, multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder, Fluticasone Furoate Inhalation Powder alone, and Fluticasone Propionate alone in the treatment of persistent asthma in adults and adolescents
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
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 [e.g., countries within the European Union]) with a diagnosis of asthma as defined by the National Institutes of Health [NIH, 2007] at least 12 weeks prior to Visit 1.
- •N.B. Target to randomise approximately 15% of subjects aged 12-17years.
- •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 oestrogen/progestin or progestin only)
- •Any intrauterine device (IUD) with a documented failure rate of less than 1% per year
- •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 days)
- •Female subjects should not be enrolled if they 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 10 or Early Withdrawal. In addition a urine pregnancy test will be performed on all females of childbearing potential at randomisation (Visit 3) and subjects will be given a home urine pregnancy kit at Visit 10 for use during the follow-up period.
- •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, 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 =12% and =200mL 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 the Screening Visit.
- •6. Current Anti-Asthma Therapy: All subjects must be using an ICS with or without LABA for at least 12 weeks prior to Visit 1.
- •Two populations are eligible for enrolment:
- •Subjects maintained on a stable ICS dose (FP 500mcg twice daily or equivalent) for 4 weeks prior to Visit 1.
- •Subjects maintained on a stable dose of an ICS/LABA mid-dose combination product (e.g., Seretide/Advair 250/50 twice daily or equivalent via other combination products or via separate inhalers) for at least 4 weeks prior to Visit 1. Subjects taking Symbic
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 hypercapnia, 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
- •within 12 weeks of Visit 1 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 subject at risk through study participation or
- •would confound the interpretation of the efficacy results if the condition/disease
- •exacerbated during the study for further informaiton view protocol.
- •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 DPI (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 and completion of the daily diaries.
- •11. Tobacco Use: Current smoker or a smok
研究者
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