EUCTR2012-001483-29-GB进行中（未招募）不适用
A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-WAY CROSSOVER STUDY TO EVALUATE THE EFFICACY AFTER ALLERGEN CHALLENGE, SAFETY, AND TOLERABILITY OF TWO DOSES OF INHALED CHF6001 DPI AFTER 9 DAYS OF TREATMENT IN ADULT PATIENTS WITH ASTHMA.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1.Written informed consent (IC) prior to any studyrelated
- •procedures;
- •2.Non or exsmokers
- •3.Male or female aged between 18 and 60 years;
- •4.Body mass index between 18 and 32 kg/m2 inclusively;
- •5.A cooperative attitude and ability to be trained about the proper use of the Aerolizer® DPI and to perform spirometry;
- •6.Diagnosis of intermittent or persistent mild to moderate allergic asthma, steroidnaïve and generally in good health;
- •7.Predisposition to an allergic reaction (atopy) to at least one common
- •aeroallergen
- •8.At the time of randomisation, a confirmed dualresponder”
- •having demonstrated both a late asthmatic response and an early asthmatic response.
- •9.Sputum producer cohort only: able to produce an adequate induced sputum sample,
- •10 hours after the allergen challenge at screening.
- •10.No regular antiasthmatic medication except salbutamol inhaler on an as needed basis” starting from the first screening visit;
- •11.Willing to use an approved method of contraception from the time of dose administration and until 90 days after the last dose of study drug.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Worsening of asthma or a respiratory tract infection within 4 weeks of any screening procedure requiring a change in asthma therapy or is deemed clinically significant by the investigator;
- •2.History of lifethreatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures or hospitalisation (including emergency room visits) for the treatment of asthma within 3 months of any screening procedure, or have been hospitalized for asthma more than twice in last 12 months;
- •3.Pregnant or lactating women.
- •4.History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness;
- •5.History or symptoms of significant neurologic disease, including transient
- •ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances;
- •6.Symptomatic with hay fever at screening or predicted to have symptomatic hay fever during the study;
- •7.Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease, uncontrolled gastrointestinal disease; neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study.
- •8.Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
- •9.History of serious adverse reaction, severe hypersensitivity or allergy to any drug or in any other circumstance (e.g. anaphylaxis);
- •10.Use of systemic corticosteroids, nebulised bronchodilators, oral beta2agonists 6 weeks prior to study entry;
- •11.Use of leukotrienes modifiers, roflumilast, cromoglycate 4 weeks prior to study entry;
- •12.Use of long acting 2agonists and/or inhaled corticosteroids (ICS) within 6 months prior to study entry;
- •13.Use of short or longacting nonsedative
- •antihistamines within 2 or 7 days, respectively, prior to screening until the end of the study;
- •14.Chronic use of any other medication for treatment of allergic lung disease other than shortacting bronchodilators taken as needed during the study;
- •15.Receipt of an investigational drug treatment within the preceding 30 days, or a longer and more appropriate time as determined by the Investigator
- •16.Blood draws of 250 millilitres (mL) or more within 45 days prior to enrolment in the study;
- •17.Ongoing use of tobacco products or previous usage within the past 12 months or past history greater than or equal to 5 packyears.
- •18.Lung disease other than intermittent or mild to moderate allergic asthma;
- •19.Recent (less than 1 year) history of alcohol dependency;
- •20.Unwillingness or inability to comply with the study protocol for any other reason;
研究者
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