NCT01197482终止不适用
Inhaled Steroids and Control of Severe Asthma: Comparison of the AKITA Technology Versus Conventional MDI (INHALE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Asthma control
研究概览
简要总结
Investigational device: AKITA 2 device versus conventional metered-dose inhaler (MDI)
Objectives: To explore if inhalative fluticasone application by means of the AKITA technology would result in a better symptom control in patients with severe persistent asthma as compared to inhalative application of fluticasone by a conventional MDI.
Study design: open label, cross-over (one AKITA, one MDI arm)
Patients: 20 Patients with severe persistent asthma
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe persistent asthma bronchiale with diagnosis according to the criteria of the Global Initiative for Asthma (GINA) executive summary
- •Treatment with at least inhaled corticosteroids (ICS) and long acting b agonists (LABA)
- •Evidence of inflammatory triggered form of asthma with at least one of the following:
- •sensitization to typical aerogenous allergens
- •increased Serum IgE levels
- •Eosinophilia in peripheral blood
- •Proven Eosinophilia in sputum differential (> 3%) in the previous 2 years
- •at least 2 exacerbations of asthma within the previous 24 months leading to unscheduled presentation at a health care provider and/or systemic corticosteroid
- •Signed informed consent
- •Requirements of the local ethics committee are met
排除标准
- •Acute exacerbation of asthma within the last 6 weeks Rtot > 350% predicted capillary pO2 < 60mmHG, pCo2 > 50mmHG near fatal asthma or anaphylaxis in history
- •Age ≤ 18 and > 80 years
- •Active smoking or > 15 pack-years former smoking
- •Oral steroid treatment with a prednisolon-equivalent dose exceeding 10 mg per day
- •Pregnancy, nursing females
- •Female without use of effective contraceptive method
- •Treatment with investigational drugs over the past 30 days or during the course of the trial
- •Severe and uncontrolled gastroesophageal reflux disease
- •Ongoing psychiatric disorder
- •Treatment with systemic corticosteroids for any reason other than asthma
- •Other active lung diseases
- •Medical history of other uncontrolled diseases 3 months prior randomization (e.g. infections, coronary heart diseases and metabolic diseases)
- •Any history of malignancy requiring ongoing treatment and/or limiting life-expectancy
- •Clinically significant abnormalities in electrocardiogram (ECG) or laboratory exams
- •Asthma related to non-steroidal anti-inflammatory drug (NSAID)
- •Insulin dependent diabetes mellitus
结局指标
主要结局
Asthma control
时间窗: 38 weeks
Changes in asthma control, measured by Juniper Asthma Control Questionnaire during the 16 week treatment period in AKITA versus MDI based steroid application. Physician will assess level of asthma control in accordance with criteria from Gaining Optimal Asthma Control (GOAL) study.
次要结局
- Standardized asthma related quality of life questionnaire (AQLQs)(38 weeks)
- Steroid, fluticasone and reliever medication use(38 weeks)
- Measurement of Fractional Concentration of Nitric Oxide in Exhaled Air (feNO)(38 weeks)
- Cell differential in induced sputa(1 day)
- Lung function(38 weeks)
- Capillary blood gas analysis(38 weeks)
- Adrenal function(38 weeks)
- Diffusing capacity for carbon monoxide(38 weeks)
研究者
Carmen Brittinger
KKS Sponsor representative
Philipps University Marburg Medical Center
研究点 (3)
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