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临床试验/CTRI/2017/01/007711
CTRI/2017/01/007711尚未招募未知

Open, multicenter, randomized, comparative study of efficacy and safety ofpharmaceutical products Formair metered-dose inhaler, 12 μgand Atimos, aerosol in the metered-dose inhaler, 12 μg in patients with partlycontrolled bronchial asthma. - FormoterolMDI

Rus Biopharm0 个研究点目标入组 150 人开始时间: 待定最近更新:
相关药物

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
150

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

入选标准

  • The diagnosis of persistent bronchial asthma (BA) is determined according to the Guidelines GINA (2015) not less than 6 months before the screening visit
  • The need for combined broncholytic therapy with long-acting β-agonist (LABA) together with inhaled glucocorticosteroids (IGCS)
  • The results of the questionnaire ACQ-5 >= 0.75 and <1.5 points

排除标准

  • Patients in need of the selected starting supporting therapy of asthma.
  • Contraindications to IGCS therapy, hypersensitivity to Formoterol, Salbutamol, or any component of the study drug, reference drug and Salbutamol.
  • Body mass index (BMI) > 35 kg/m 2.
  • Chronic obstructive pulmonary disease (COPD), according to the version of the GOLD Guidelines (2015) has been diagnosed.

研究者

发起方
Rus Biopharm

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