PER-052-16已完成未知
A multi-center, randomized, 12-week treatment, doubleblind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 64 人开始时间: 2017年3月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1 Written informed consent.
- •2 Male and female adolescents aged ≥ 12 and ≤ 75 years old.
- •3 Documented diagnosis of asthma for a period of at least 3 months prior to Screening (Visit 1)
- •4 Use of low dose ICS, with or without controller at stable dose for at least 1 month prior to Screening (Visit 1)
- •5 Symptomatic at screening despite treatment with existing therapy. CQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (ie inadequately controlled).
- •6 Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102.
- •7 Demonstrate an increase in FEV1 of ≥12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol at Visit 101.
排除标准
- •1Smoked or inhaled tobacco products.
- •2 Asthma attack/exacerbation.
- •3Intubation for a severe asthma attack/exacerbation.
- •4Clinical condition to be worsened by ICS.
- •5Respiratory tract infection or asthma worsening.
- •6Clinically significant oropharyngeal candidiasis.
- •7Chronic conditions affecting the upper respiratory tract.
- •8Chronic lung diseases other than asthma.
- •9Type I or II diabetes.
- •10Clinically significant laboratory abnormality.
- •11Use of investigational drugs.
- •12Clinically significant condition.
- •13History of myocardial infarction.
- •14Use of agents known to prolong the QTc interval.
- •15Long QT syndrome.
- •16Clinically significant ECG abnormality.
- •17Malignancy of any organ system.
- •18Hypersensitivity or intolerance to any of the study drugs.
- •19Rare hereditary problems of intolerance to milk products.
- •20Not achieved an acceptable spirometry results.
- •21Prohibited asthma-related.
- •22Prohibited medications.
- •23Narcolepsy and/or insomnia.
- •24Immunotherapy.
- •25Do not have a fixed residence or are detained.
- •26Directly associated with study team or their family.
- •27Unable to use Concept1, Twisthaler®, Accuhaler® or MDI.
- •28Alcohol or other substance abuse.
- •29Non-compliance to medication
- •30Do not maintain regular day/night cycles.
- •31 Pregnant or nursing women.
- •32 Women of child-bearing potential unless use of contraception.
研究者
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