ISRCTN48047493已完成2 期
A multicentre, randomised, double-blind, placebo-controlled, cross-over study to evaluate the efficacy, safety and tolerability of MEM 1414 (600 mg) on the allergen-induced late asthmatic response in steroid-free subjects with mild allergic asthma
Memory Pharmaceuticals Corp. (USA)0 个研究点目标入组 16 人开始时间: 2008年11月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects between the ages of 18 and 55 years (inclusive)
- •2. Non- or ex-smokers who are expected to not smoke for the duration of the trial (an ex-smoker being defined as someone with less than 10 pack-year history and who has completely stopped smoking for at least 12 months before screening for this study)
- •3. Clinically stable, steroid-free mild allergic asthmatics who:
- •3.1. Have had a well-established, documented asthma diagnosis for at least 6 months prior to screening for this study
- •3.2. Have a forced expiratory volume in one second (FEV1) greater than or equal to 70% of predicted for age and height on screening days 1 and 2
- •3.3. Do not require any controller drugs for asthma
- •3.4. Have been on an as needed regimen of short acting beta 2-agonists
- •4. In the previous year or at screening, a positive allergen skin prick test (SPT) wheal response to house dust mite (HDM)
- •5. At screening, a demonstrated airway hyper-responsiveness to methacholine chloride, with a provocative concentration resulting in a 20% decrease in FEV1 (PC20FEV1) of 16 mg/mL or less (a PC20 methacholine value within the previous 12 months may be used to make this determination)
- •6. At screening, a minimum decrease in FEV1 in both early (0 - 3 hours) and late (3 - 10 hours) allergen-induced response of greater than or equal to 15% following inhaled allergen challenge
- •7. Due to unknown risks and potential harm to the unborn foetus, sexually active women of childbearing potential must use a reliable method of birth control while participating in this study and for a period of 90 days following the last drug administration. Reliable methods of birth control are considered to be: abstinence (not having sex), oral contraceptives (the pill), intrauterine device (IUD), Depo-Provera, Norplant, tubal ligation (tubes tied), or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Females who do not use an acceptable contraceptive regimen will be allowed to participate in this study only if they are not considered to be of childbearing potential: females who have had a hysterectomy or tubal ligation, are clinically diagnosed infertile, or are in a menopausal state (minimum of a year without menses).
- •8. Pregnant women are excluded from participation in this study. Because some methods of birth control are not 100% reliable, a negative pregnancy test is required at screening.
- •9. Male subjects must abstain from unprotected sexual intercourse during the study and for a period of 90 days following the last drug administration
- •10. Are in good general health and are expected by the investigator to complete the clinical trial as designed
- •11. Have voluntarily provided informed consent and have signed an informed consent form (ICF) indicating that the purpose of the study has been explained, and are willing and able to adhere to the study regimen and study procedures described in the ICF
排除标准
- •1. Any hospitalisations due to asthma in the past 3 years
- •2. Treatment with the following medications:
- •2.1. Oral corticosteroids:
- •2.1.1. More than once in the previous 12 months, or
- •2.1.2. Within 8 weeks of screening
- •2.2. Inhaled or nasal corticosteroids in the previous 4 weeks before screening for this study
- •2.3. A leukotriene receptor antagonist (LTRA), 5-lipoxygenase inhibitor, theophylline or cromones (e.g. cromolyn, nedocromil) in the previous 2 weeks before screening for this study
- •2.4. Long-acting beta2-agonists (LABA) or anticholinergics in the previous 7 days before screening for this study
- •2.5. Short-acting antihistamines and tranquilisers in the previous 7 days before screening for this study
- •2.6. Long-acting antihistamines in the previous 2 weeks before screening for this study
- •2.7. Anti-IgE in the previous 6 months before screening for this study
- •2.8. Previous treatment with immunotherapy
- •2.9. Vaccinations (e.g. anti-influenza) in the previous 3 months before screening for this study
- •2.10. Antidepressants within the previous 2 weeks before screening for this study
- •2.11. Beta-adrenoreceptor blocking agents within the previous 3 days before screening for this study
- •3. Significant illness or disease other than asthma
- •4. History of severe hypersensitivity or allergy to any drug
- •5. Presence of any active respiratory tract infection, whether bacterial, viral, or fungal in origin within 3 weeks of screening
- •6. Have unstable cardiovascular, gastrointestinal, hepatic, musculoskeletal, metabolic, endocrine, neurological or psychiatric disease or have had any clinically significant medical condition other than asthma within 1 month (30 days) prior to screening
- •7. Have rheumatoid arthritis, a connective tissue disorder, or any other condition known to be associated with chronic inflammation (e.g. inflammatory bowel disease)
- •8. Major surgery in the past 3 months before screening
- •9. Have evidence of significant renal insufficiency, indicated by a serum creatinine greater than the upper limit of normal at screening
- •10. Have either of the following liver test abnormalities at screening:
- •10.1. Aspartate transaminase (AST) or alanine transaminase (ALT) 1.5 times greater than the upper limit of normal
- •10.2. Total bilirubin greater than 1.2 times the upper limit of normal
- •11. Have insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus, as evidenced by HbA1C level greater than or equal to 8.0% at screening
- •12. Have a history of malignancy other than in situ tumours
- •13. Have a history of bone disease (e.g., osteoporosis, osteopenia) or suffered from a bone fracture in the previous 12 months before screening
- •14. Have any of the following haematologic abnormalities at screening:
- •14.1. For females: haemoglobin less than 7.4 mmol/L
- •14.2. For males: haemoglobin less than 8 mmol/L
- •14.3. White blood cell (WBC) count less than 3.0 x 10^3/mm^3
- •14.4. Platelet count less than 100,000/mm^3
- •15. Are known to have or be a carrier of the hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody (unless confirmatory tests are negative)
- •16. Have significant blood loss (greater than 500 ml) or donated blood in the 30 days before screening
- •17. Have participated in a clinical trial evaluating an Investigational Product in the previous 3 months before screening for this study
- •18. Have a positive urine drug screen (UDS), which includes cotinine, at screening
- •19. Recent (less than 1 year) history of alcohol dependency. Subjects who have
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