EUCTR2016-005164-34-NL进行中（未招募）1 期
A randomized, double-blind, double dummy, active-controlled, 3-period complete cross-over study to assess the bronchodilator effect and safety of two doses of QVM149 compared to a fixed dose combination of salmeterol/fluticasone in patients with asthma
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
- 114
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
- •Male and female adult patients = 18 years old and = 75 years.
- •Patients with a documented physician diagnosis of asthma for a period of at least 12 months prior to Visit 1 (Screening).
- •Patients who have used ICS and LABA combinations for asthma for at least 3 months and at a stable medium or high dose of ICS for at least 1 month prior to Visit 1 (Screening).
- •Pre-bronchodilator FEV1 of < 80 % of the predicted normal value at screening Visit 1
- •(spirometry will not be repeated at baseline prior to randomization).
- •Patients who demonstrate an increase in FEV1 of = 12 % and 200 mL after administration of 400 µg salbutamol/360 µg albuterol (or equivalent do se) at
- •Visit 1 (Screening). All patients must perform a reversibility test at Visit 1 (Screening). If reversibility is not demonstrated at Visit 1 (Screening), then, reversibility testing may be repeated once during the screening period.
- •If reversibility is not demonstrated at Visit 1 (retesting allowed once), patients must be screen failed. Spacer devices are not permitted during reversibility testing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Patients who have smoked or inhaled tobacco
- •products within the 6 month period prior to Visit 1
- •Patients who have had an asthma
- •attack/exacerbation requiring systemic steroids or
- •hospitalization or emergency room visit within 6
- •weeks of Visit 1
- •Patients with narrow-angle glaucoma,
- •symptomatic benign prostatic hyperplasia (BPH) or
- •bladder-neck obstruction or severe renal impairment
- •or urinary retention
- •Patients who have had a respiratory tract
- •infection or asthma worsening within 4 weeks prior to
- •Patients with any chronic conditions affecting the
- •upper respiratory tract
- •Patients with a history of chronic lung diseases
- •other than asthma, including (but not limited to)
- •COPD, sarcoidosis, interstitial lung disease, cystic
- •fibrosis, clinically significant bronchiectasis and active
- •tuberculosis.
- •Patients with Type I diabetes or uncontrolled
- •Type II diabetes (HbA1c >9% at screening).
- •Patients who have a clinically significant ECG abnormality at Visit 1
- •Patients with a history of hypersensitivity or
- •intolerance to any of the study drugs (including
- •excipients)
- •Patients with narcolepsy and/or insomnia.
- •Patients on Maintenance Immunotherapy
- •(desensitization) for allergies for less than 3 months
- •prior to Visit 2 or patients on Maintenance
- •Immunotherapy for more than 3 months prior to Visit 2
- •but expected to change throughout the course of the
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential must use
- •Highly effective contraception methods
- •Patients who have discontinued LAMA therapy in
- •the past for any safety, tolerability or perceived lack of
- •efficacy reason.
- •History of paradoxical bronchospasm in
- •response to inhaled medicines.
- •Patients with a history of clinically relevant
- •bronchoconstriction upon repeated forced expiratory
- •Patient with a serum potassium level below the
- •laboratory limit of normal at screening.
研究者
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