NL-OMON52410已完成4 期
A Phase 4, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of the effect of dupilumab on sleep disturbance in patients with uncontrolled persistent asthma - LPS16677 Morpheo
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
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
- 18 至 99（—）
入选标准
- •-Physician diagnosis of asthma based on the Global Initiative for Asthma (GINA)
- •2020 Guidelines
- •for >=12 months treated with medium to high dose inhaled corticosteroid (ICS)
- •and a second
- •controller (ie, long-acting beta agonist, leukotriene receptor antagonist). A
- •third controller is allowed
- •but not mandatory. The dose regimen should be stable for at least 1 month
- •before the study and
- •during the screening period
- •-History of at least one severe asthma exacerbation within 1 year prior to
- •screening. Severe exacerbation is
- •defined as deterioration of asthma that results in emergency treatment,
- •hospitalization due to
- •asthma, or treatment with systemic steroids (oral or injectable)
- •-Eosinophils >=150 cells/µL and fractional exhaled nitric oxide (FeNO) >=25 ppb
- •during screening, prior to randomization
- •* Historical values of blood eosinophil count meeting the eligibility criterion
- •within 6 months prior to screening Visit 1 in the absence of oral
- •corticosteroid (OCS)
- •treatment are allowed.
- •* FeNO value to be checked for eligibility at Visit 2 as well.
- •-Asthma control questionnaire (ACQ)-5 >=2.5 at screening Visit 1 and Visit 2,
- •prior to randomization
- •-Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) <= 80% of
- •predicted normal
- •during screening, and at Visit 2, prior to randomization
- •-Exhibit bronchodilator reversibility (>=12% and 200 mL improvement in FEV1 post
- •short-acting beta
- •agonist administration) during screening period, prior to randomization, unless
- •reversibility test
- •meeting the inclusion criteria was done within 6 months prior to screening
- •-Weekly average nocturnal awakenings due to asthma symptoms in the week prior
- •to screening
- •Visit 1 is >=1
排除标准
- •-Current smoker
- •-Former smoker for 10 years with a smoking history of >10 pack-years
- •-Severe asthma exacerbation during screening, prior to randomization
- •-History or clinical evidence of chronic obstructive pulmonary disease (COPD)
- •including Asthma-
- •COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung
- •sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis,
- •Churg-Strauss
- •-History of or current evidence of clinically significant non-respiratory
- •diseases that in the opinion of
- •the investigator may interfere with the aims of the study or put the
- •participant at undue risk
- •-Active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a
- •history of incompletely
- •treated TB will be excluded unless it is well documented by a specialist that
- •the participant has
- •been adequately treated and can now start treatment with a biologic agent, in
- •the medical judgment
- •of the Investigator and/or infectious disease specialist. Tuberculosis testing
- •would be performed on
- •a country by country basis, according to local guidelines if required by
- •Regulatory Authorities or
- •ethics boards
- •-Diagnosed active endoparasitic infection; suspected or high risk of
- •endoparasitic infection, unless
- •clinical and (if necessary) laboratory assessment have ruled out active
- •infection before randomization
- •-History of human immunodeficiency (HIV) infection or positive HIV test at
- •screening Visit 1
- •-Active chronic or acute infection requiring treatment with systemic
- •antibiotics, antivirals,
- •antiprotozoals, or antifungals within 2 weeks before screening
- •-Known or suspected immunodeficiency including history of invasive
- •opportunistic infections,
- •despite infection resolution
- •-Current evidence of clinically significant oncological disease
- •-History of systemic hypersensitivity or anaphylaxis to any biologic therapy
- •-Severe uncontrolled depression
- •-Sleep disturbances not related to asthma, including sleep apnea, hypersomnia,
- •or insomnia
- •secondary to chronic pain, atopic dermatitis (AD), COPD or other conditions
- •-Participant who works night shift (ie, any work between 8 pm and 6 am)
- •-Erratic sleep habits, as determined by the Investigator
- •-Restless leg syndrome or periodic limb movement disorder
- •-Chronic treatment with OCS for more than 2 weeks before screening Visit 1
- •- Participant taking sedative, anxiolytic, or hypnotic treatments, including
- •melatonin, within 3 months
- •before randomization
- •-Participant taking systemic sedative antihistamines (excluding newer
- •generations of
- 另有 13 项未显示
研究者
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