EUCTR2007-004608-11-FR进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, parallel group study to investigate the safety and tolerability of 14-days treatment with an inhaled dose of QMF149 (500/800) in mild to moderate asthmatic patients.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
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 adult patients aged 18-65 years (inclusive), who have signed an Informed Consent Form prior to the initiation of any study-related procedure
- •2. Patients with mild-moderate asthma, diagnosed according to current GINA guidelines (National Institutes of Health. National Heart, Lung and Blood Institute, 2006)
- •3. FEV1 at Visits 1 and 2 are =60% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a minimum of 24 hours for a long acting ß2-agonist.
- •4. BMI must be within the range of 18-32.
- •5. Except for asthma, subjects must be free of any clinically significant disease that might compromise patients' safety or compliance, would interfere with the study evaluations, or preclude completion of the trial.
- •6. Non-smokers or light smokers (=10 cigarettes per day), with a smoking history of 10 pack years or less.
- •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
- •Subjects meeting any of the following criteria will be excluded from entry into or continuation in the study:
- •1. Patients who suffer from COPD (GOLD).
- •2. Patients who have been hospitalized or had emergency room treatment for an acute asthma attack in the 6 months prior to Visit 1 or between Visit 1 and Visit 2.
- •3. Patients who have had a respiratory tract infection within 1 month prior to Visit 1. Patients who develop a respiratory tract infection during the screening period will be ineligible for randomisation, but will be permitted to re-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection).
- •4. Patients with a QTc interval above 0.45 msec for males and 0.47 msec for females at the screening visit (Visit 1).
- •5. Patients who have depression or with a history of treated depression within 6 months of screening.
- •6. Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
- •7. Patients must not be taking the following medications at entry into the study (Visit 2); the washout period (prior to Visit 2) for each of the relevant types of medications is specified below (Treatments for asthma and allied conditions):
- •Asthma medication Washout period
- •Fixed combinations of beta2-agonists and inhaled corticosteroids 72 hours
- •Long acting beta2-agonists 24 hours
- •Inhaled corticosteroids (ICS) 72 hours
- •Parenteral and oral corticosteroids 3 months
- •Theophylline and other xanthines 1 month
- •Leukotriene antagonists 48 hours
- •Anti-cholinergics:
- •short acting 8 hours
- •long acting 7 days
- •Prohibited medication Washout period
- •Non-potassium sparing diuretics 30 days
- •Beta-blocking agents 30 days
- •Quinidine-like medications 30 days
- •Tri-cyclic antidepressants, fluoxetine or any other specific serotonin
- •uptake receptor inhibitor, monoamino-oxidase inhibitors 30 days
- •Desensitization therapy 30 days
- •Terfenadine, astemizole, mizolastin and other drugs contra-indicated
- •for QT prolongation 30 days
- •Use of other investigational drugs 30 days or 5 half-lives of enrollment,
- •whichever is longer
- •8. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •9. Pregnant women or nursing mothers
- •10. Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
- •11. History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
- •12. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •13. History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
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