EUCTR2008-004756-69-DE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, 4-way crossover clinical trial to assess the efficacy, safety, tolerability and pharmacokinetics of single doses of LAS100977 administered by inhalation to stable asthma patients
aboratorios Almirall, S.A.0 个研究点开始时间: 2008年9月10日最近更新:
适应症
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
- Male
入选标准
- •1. Adult male subjects aged 18-70 years (both included).
- •2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2007 update) for at least 6 months prior to screening.
- •3. Maintenance on a stable dose of inhaled corticosteroids together with either a short or a long-acting beta2-agonist over the previous 6 weeks prior to screening.
- •4. Screening FEV1 value of 60% < FEV1 <= 85% of the predicted normal value after a washout of at least 6 hours for short-acting beta2-agonists and 72 hours for long-acting beta2-agonists, if applicable.
- •- Predicted normal values to be used for calculation purposes are to be based on European Community for Steel and Coal predicted values (Quanjer et al. 1993).
- •5. FEV1 reversibility > 12% and an absolute increase of at least 200 ml over baseline value within 30 minutes after inhalation of 400 µg (four inhalations) of salbutamol via a metered dose inhaler.
- •6.Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation [i.e. within the interval: 0.8 x pre-salbutamol FEV1 (screening) – 1.2 x pre-salbutamol FEV1 (screening)].
- •7. Normal values or non-clinically relevant abnormalities in the results of the physical examination and laboratory tests at screening, as judged by the medical investigator.
- •8. Normal values or abnormalities not clinically relevant in the screening 12-lead ECG, as judged by a cardiologist. QT and QTc [calculated according to Bazett’s formulae (QTc=QT [msec] / RR [sec]1/2)] lower than 500 milliseconds and lower than or equal to 450 milliseconds, respectively, in the ECGs performed at screening and before the first IMP administration.
- •9. Ability to communicate adequately with the investigator and comply with the protocol requirements, instructions and protocol-stated restrictions.
- •10. Ability to use an inhaler device and perform spirometries.
- •11. Eligibility and ability to participate in the trial and consent to do so in writing after the purpose and nature of the investigation have been explained.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Smoking history during the last 12 months or history of smoking more than 10 pack-years.
- •- Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day / 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history).
- •- Patients smoking other tobacco types will not be included if they meet the above mentioned cigarette criterion as well.
- •2. Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc), which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient’s ability to take part in it.
- •3. Presence of relevant pulmonary diseases or history of thoracic surgery, such as:
- •Known active tuberculosis.
- •History of interstitial lung or pulmonary thromboembolic disease.
- •Pulmonary resection during the past 12 months.
- •History of status asthmaticus.
- •History of bronchiectasis secondary to respiratory diseases (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
- •History of chronic bronchitis, emphysema, allergic bronchopulmonary aspergillosis or respiratory infection within the 4 preceding weeks of the first morning IMP administration.
- •4. Hospitalisation or emergency room treatment for acute asthma in the 6 weeks prior to screening, between screening and the start of the first treatment period, or between treatment periods.
- •5. Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- •6. Positive laboratory test for urine illicit drug screening.
- •7. Positive test Hepatitis B surface antigen or HBc, HIV and Hepatitis C antibodies. Patients vaccinated for Hepatitis B and not infected from the disease can take part in the trial.
- •8. History of severe allergy (anaphylaxis, angioneurotic oedema) or drug hypersensitivity reactions or hypersensitivity to drugs chemically related IMP.
- •9. Intention to use any concomitant medication not permitted by this protocol or insufficient washout period for a particular prohibited medication (see section 10.3).
- •10. Treatment with ß2-antagonists (including eye drops).
- •11. Treatment with drugs that may modify QT interval (non-potassium sparing diuretics, MAOIs, TCAs, SSRIs, antipsychotic agents, serotonin receptor agonists, macrolide antibiotics, fluoroquinolone antibiotics, anti-protozoal antibiotics and antihypertensive agents).
- •12. Excessive coffee, tea or chocolate consumption (more than 6 cups/day on average) or cola / caffeine containing drinks (more than 6 glasses/day).
- •13. Loss of more than 500 ml of blood within the previous 3 months, or more than 250 ml within the month before entering the trial.
- •14. History of drug and/or alcohol abuse during the last 2 years, which may interfere with the trial activities compliance.
- •15. Treatment with any Investigational Medicinal Product (IMP) within 6 weeks prior to screening or the equivalent time to 6 half-lives of the IMP, which is longer.
- •16. Poor venous access.
- •17. Vulnerable subjects
研究者
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