Dose Response Evaluation of CHF 1535 HFA pMDI in Asthmatic Patients Using Lung Function, Adenosine Monophosphate Bronchial Challenge and Fractional Exhaled Nitric Oxide (FENO)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Lung function
研究概览
简要总结
The aim of this exploratory investigation is to evaluate if the Forced Expiratory Volume in the 1st second (FEV1) measurements, fractional exhaled nitric oxide (FENO) and Provocative Concentration 20 (PC20) after Adenosine Monophosphate (AMP) bronchial challenge evaluated after administration of a fixed combination of a Long-acting Beta-2-agonist (LABA) and an Inhaled Corticosteroid (ICS) at increasing doses may be suitable to demonstrate a dose response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18-50 years of age, who have signed an informed consent form.
- •Clinical evidence of asthma
- •Steroid naïve asthmatic patients
- •FEV1 at Screening Visit is >70 % of the predicted value and at least 2.0 L.
- •Body Mass Index between 18 and
- •Sensitivity to AMP at Screening Visit.
- •FENO levels >25 ppb at the Screening Visit
排除标准
- •Having received an investigational product within 2 months of Screening Visit.
- •Inability to comply with study procedures or with study treatment intake.
- •Any significant lung disease which is considered by the investigator to be clinically significant.
- •Patients who suffer from Chronic Obstructive Pulmonary Disease (COPD)
- •Previous or current smokers who have a smoking history greater than 5 pack years.
- •Patients with any uncontrolled disease that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
- •Patients with QTc >450msec at the Screening Visit.
- •Patients with serum potassium <3.5 mEq/L or >6 mEq/L.
- •Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- •Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
- •Patients who have undergone major surgery in the previous 3 months.
- •Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit.
- •Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
- •Patients currently treated with anti-IgE Antibodies.
- •Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit.
- •Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD).
- •Females who are pregnant, lactating or planning to become pregnant
研究组 & 干预措施
Placebo
Placebo pMDI
干预措施: Placebo (Drug)
Low dose
BDP/formoterol pMDI low dose
干预措施: BDP/formoterol (Drug)
High dose
BDP/Formoterol pMDI high dose
干预措施: BDP/formoterol (Drug)
结局指标
主要结局
Lung function
时间窗: from 0 to 4 h post dose
FEV1 area under the curve from 0 to 4 hour post dose (AUC0-4h)
Fractional Exhaled Nitric Oxide (FeNO)
时间窗: 4 h post dose
Fractional exhaled nitric oxide (ppb). FeNO is a biomarker measured in a breath test and it is a validated method for measuring the airway inflammation in asthma.
PC20 after AMP challenge
时间窗: 4 h post dose
Provocative Concentration of AMP causing a 20% fall in FEV1.
次要结局
- FENO(2 h post dose)