CTIS2022-501899-26-00招募中1 期
Double-blind, randomized, active-controlled, two-way cross-over study, with 12-week treatment duration per period, to evaluate the efficacy and safety of QMF149 (indacaterol acetate / mometasone furoate) compared to budesonide in children from 6 to less than 12 years of age with asthma - CQMF149G2301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 189
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
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Male and female children from 6 to less than 12 years of age with asthma for at least 1 year prior to study enrolment, inadequately controlled on low dose inhaled steroids.Or formerly adequately controlled on a combination therapy of low-dose steroids and add on medication but showing inadequate control after the initial, run in’ period of the trial when treated with a low dose inhaled steroid (fluticasone propionate) and qualifying for treatment with low dose inhaled corticosteroids plus a long-acting beta agonist.
排除标准
- •Prior intubation for asthma, Patients with severe asthma exacerbation requiring in the previous months either systemic steroids or hospitalization due to asthma or emergency room visit., Subjects receiving pre-defined medications unless they undergo the required washout period prior to Treatment visit (Day 1) and follow the adjustment through the treatment period., Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Screening visit or between Screening and End of Run-In. Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.
研究者
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