EUCTR2011-003337-34-SK进行中（未招募）1 期
HZA106853: A dose-ranging study of vilanterol (VI) inhalation powder in children aged 5-11 years with asthma on a background of inhaled corticosteroid therapy.
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 465 人开始时间: 2013年6月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 465
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: Written informed consent from at least one parent/ legal guardian to take part in the study.
- •If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement. The study investigator is accountable for determining a child's capacity to assent to participation in a research study, taking into consideration any standards set by the responsible IEC/IRB.
- •Subject and their legal guardian understand that the study requires them to be treated on an outpatient basis.
- •Subject and their legal guardian understand that they must comply with study medication and study assessments including recording of symptom scores and rescue albuterol/salbutamol use, attending scheduled study visits, and being accessible by a lephone call.
- •2. Age: 5-11 years at visit 1.
- •3. Gender: Male and pre-menarchial female. Pre-menarchial females are defined as any female who has yet to begin menses.
- •4. Diagnosis of asthma: Subjects must have a history of symptoms consistent with a diagnosis of asthma for at least 6 months prior to Visit 1.
- •5. Reversibility component for subjects able to perform acceptable pre and post bro-nchodilator FEV1 during the screening visit: Subjects must attempt lung function reversibility in FEV1 within 10-40 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol (or equivalent nebulized treatment with albuterol/salbutamol solution). No specific reversibility is requir- ed however the percent reversibility will be documented. Subjects unable to perform acceptable pre and post bronchodilator FEV can still be enrolled provided they meet all other subject selection criteria.
- •6. Asthma Severity: Subjects must have a pre-bronchodilator PEF between =50% to =90% of their best post-bronchodilator value (calculated from Visit 1 reversibility testing using spirometry generated PEF values).
- •7. Current asthma therapy: Subjects must be receiving stable asthma therapy (short acting beta-agonist (SABA) plus ICS (total daily dose FP 250mcg or equivalent) for at least 4 weeks prior to screening:
- •Please see table in study Protocol page 19)
- •8. Ability to use Dry Powder Inhalers: Subjects must demonstrate the ability to use the Novel Dry Powder Inhaler (NDPI) and the DISKUS/ACCUHALER under the supervision of their parents/carers.
- •9. Short-Acting Beta2-Agonists (SABA): All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 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. Albuterol/salbutamol 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 subject throughout the study.
- •10. Peak Flow Meter/Daily Diary: A subject must be able to use the study-provided peak flow meter and the subject/caregiver must be able to maintain the electronic diary record.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 465
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Life Threatening Asthma: Subjects with a history of life-threatening asthma.
- •Defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s).
- •2. Asthma Exacerbation: Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening.
- •3. Concomitant medications: Potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g. Clarithromycin, atazanavir, indinavir, itraconazole, ketoconazole, nefazadone, nelfinavir; ritonavir; saquinavir; telithr omycin, troleandomycin, voriconazole, mibefradil, cyclosporine)
- •(Please see table on page 21 of study protocol)
- •4. Infections: 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.
- •5. Oropharyngeal Examination: A subject will not be eligible for the run-in if he/she has clinical visual evidence of candidiasis at Visit 1.
- •6. Concurrent Diseases/ Abnormalities: Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) likely to interfere with the conduct of the study.
- •7. Allergies:
- •Drug allergies: Any adverse reaction including immediate or delayed
- •hypersensitivity to any beta2-agonist, sympathomimetic drug. Known or suspected sensitivity to the constituents of the NDPI (including lactose and magnesium stearate).
- •Milk Protein Allergy: History of severe milk protein allergy.
- •8. Tobacco use: Present use of any tobacco products.
- •9. Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
- •10. Previous Exposure to Investigational Product: Subjects who have previously been exposed to VI including in clinical studies HZA112776 or HZA112777.
- •11. Parental/Guardian Factors: Parent or Guardian with 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 subject during the study
- •compliance of subject with study medication and study procedures (e.g. completion of daily diary, attending scheduled clinic visits)
- •subject safety and well-being
- •12. Children in Care: Children who are wards of the government or state are not eligible for participation in this study.
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