EUCTR2007-004345-14-GB进行中（未招募）不适用
Dose response evaluation of CHF 1535 HFA pMDI in asthmatic patients using lung function, adenosine monophosphate bronchial challenge and fractional exhaled nitric oxide (FENO). Randomized, double-blind, double-dummy, placebo controlled, multiple doses, 3-way cross-over design.
Chiesi Farmaceutici SpA0 个研究点开始时间: 2007年10月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Male and female patients 18-50 years of age, who have signed an informed consent form.
- •2. Clinical evidence of asthma, associated with one of the following:
- •a) Demonstration of =12% reversibility and 200-mL improvement of FEV1 using a standard dose of salbutamol (up to 400µg) within 30 minutes.
- •b) Historical bronchial hyper-reactivity to (=8 mg/mL) methacholine
- •3. Steroid naïve asthmatic patients
- •4. Patients whose FEV1 at Screening Visit is >70 % of the predicted value (after appropriate wash-out from bronchodilators) and at least 2.0 L.
- •5. Body Mass Index between 18 and 35.
- •6. Sensitivity to AMP causing a 20% drop in FEV1 (PC20 = 20 mg/ml) at the Screening Visit
- •7. FENO levels >25 ppb at the Screening Visit
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Having received an investigational product within 2 months of Screening Visit.
- •2. Inability to comply with study procedures or with study treatment intake.
- •3. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which is considered by the investigator to be clinically significant.
- •4. Patients who suffer from COPD as diagnosed by the GOLD guidelines (2006).
- •5. Previous or current smokers who have a smoking history greater than 5 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- •6. Patients with an uncontrolled cardiovascular, respiratory, haematologic, immunologic, renal, neurologic, hepatic, endocrine disease, or any condition that might, in the judgment of the investigator, place the patients at undue risk or potentially compromise the results or interpretation of the study.
- •7. Patients with QTc >450msec at the Screening Visit.
- •8. Patients with serum potassium <3.5 mEq/L or >6 mEq/L.
- •9. Intolerance/hypersensitivity or any contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
- •10. Patients who have a history of alcohol or substance abuse that in the opinion of the Investigator may be of clinical significance.
- •11. Patients who have undergone major surgery in the previous 3 months.
- •12. Patients who have had an exacerbation of asthma, requiring treatment with oral steroids during the last month prior to Screening Visit.
- •13. Patients treated with slow-release corticosteroids 2 months prior to Screening Visit.
- •14. Patients currently treated with anti-IgE Antibodies.
- •15. Patients who have had a respiratory tract infection within 4-weeks prior to Screening Visit.
- •16. Females not willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device (IUD).
- •17. Females who are pregnant, lactating or planning to become pregnant
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