EUCTR2016-004086-87-LT进行中（未招募）1 期
A randomized, double-blind, parallel group, multicenter, stratified, study evaluating the efficacy and safety of once daily fluticasone furoate/vilanterol inhalation powder compared to once daily fluticasone furoate inhalation powder in the treatment of asthma in participants aged 5 to 17 years old (inclusive) currently uncontrolled on inhaled corticosteroids.
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
- 870
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.Participants must be between 5 and 17 years of age inclusive, at the time of screening.
- •2.A history of symptoms consistent with a diagnosis of asthma for at least 6 months.
- •3.Pre-bronchodilator FEV1>50% to =100% predicted normal. A minimum of 2 efforts that are considered acceptable (not necessarily repeatable) are required to be eligible (see Section 11.1.1).
- •NOTE: These FEV1measurements must be acceptable and must meet the FEV1 inclusion limits (as stated above) and the reversibility requirements (below) to be eligible for the study. Participants who are unable to perform the pre-bronchodilator FEV1 manoeuvre (provide at least 2 acceptable [not necessarily repeatable]) at Visit 1 can, at the discretion of the investigator, attend the clinic once more after Visit 1 to attempt to perform the pre-bronchodilator and post-bronchodilator FEV1 manoeuvres. This should be within 14 days of Visit 1. Patients who provide an acceptable spirometry measure, but who do not meet the spirometry related criteria (Inclusion criteria 3 and 4) are considered screen failures but can be re-screened (see Section 8.3).
- •4.Lung function reversibility defined as an increase of=12% in FEV1 within 15 to 40 minutes following 2 to 4 inhalations of albuterol/salbutamol inhalation aerosol (or 1 nebulised treatment with albuterol/salbutamol solution). Use of a spacer is permitted.
- •NOTE:Participants who meet inclusion criteria 3 with a technically acceptable pre-bronchodilator FEV1 manoeuvre at Visit 1,but are then unable to perform the technically acceptable post-bronchodilator FEV1 needed for reversibility can, at the discretion of the investigator, attend the clinic once more after Visit 1 to attempt to perform both the pre-bronchodilator and post-bronchodilator FEV1 manoeuvres again. This should be within 14 days of Visit1. These FEV1 measurements must be acceptable and must meet the FEV1 inclusion limits and the reversibility requirements to be eligible for the study. Patients who provide an acceptable spirometry measure, but who do not meet the spirometry related criteria (3 and 4)can be re-screened(see Section 8.3).
- •5.Uncontrolled asthma, with a cACT/ACT score=19.
- •6.Receiving stable asthma therapy (SABA or SAMA inhaler plus ICS [total daily dose=FP 250mcg or equivalent]) for at least 4 weeks prior to Visit1 (ie, screening).
- •7.Able to replace their current SABA/SAMA treatment with salbutamol/albuterol aerosol inhaler at Visit 1 for use as needed for the duration of the study. Salbutamol/albuterol metered dose inhaler (MDI) will be administered with or without a spacer, to be used as determined by the investigator. The use or non-use of the spacer should be consistent for an individual participant throughout the study.
- •8.Male or female participants. Females of reproductive potential must agree to follow 1 of the options listed (which include abstinence) in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (see Section14.4) from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up call. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. Note: Any female participant who is lactating (breastfeeding) will not be included in the study.
排除标准
- •1. A 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. Any asthma exacerbation requiring the use of oral steroids within 6 weeks of Visit 1, systemic or depot corticosteroids within 12 weeks of Visit 1, OR ER attendance within 3 months of Visit 1 OR hospitalisation within 6 months of Visit 1.
- •3. A culture documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that has not resolved within 4 weeks of Visit 1 and which led to a change in asthma management or, in the opinion of the investigator, is expected to affect the participant’s asthma status or the participant’s ability to participate in the study.
- •4. Clinical visual evidence of oropharyngeal candidiasis.
- •5. Fasting blood glucose at screening >100 mg/dl (5.6mmol/L). NOTE: Participants who have a value that is above >100 mg/dl can have a repeat test before Visit 2.
- •6. Severe obesity (BMI above the 99th centile based on the CDC charts).
- •7. Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) that in the investigator’s opinion, preclude entry into the study due to risk to the participant or that may interfere with the conduct and/or outcome of the study.
- •8. QT interval corrected using Fridericia’s formula (QTcF) >450 msec or QTcF >480 msec in participants with bundle branch block or any other clinically significant abnormality in the Screening 12-lead ECG.
- •For purposes of data analysis, QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF).
- •Another QT correction formula, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
- •Prior/Concomitant Therapy
- •9. Use of any prohibited medications listed in Section 7.7.1. of Protocol.
- •10. Present use of any tobacco products including e-cigarettes and vaping.
- •11. Drug allergies: any adverse reaction including immediate or delayed hypersensitivity to any beta 2-agonists, sympathomimetic drug or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the ELLIPTA Inhaler (i.e. lactose or magnesium stearate).
- •12. Milk Protein Allergy: history of severe milk protein allergy.
- •13. Participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the study treatment (whichever is longer).
- •14. Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
- •15. An affiliation with the investigator site: the parents/guardians or child is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
- •16. The parent or guardian has a history of psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect:
- •validity of consent to participate in the study
- •adequate supervision of the participant during the study
- •compliance of participant with study medication and study procedures (e.g. completion of daily diary, attending sch
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