EUCTR2009-011590-32-BE进行中（未招募）1 期
A Multi-Center, Randomized, Double Blind, Placebo-Controlled, ‘add-on’ study to investigate the efficacy and safety of 24 weeks intravenous treatment with QAX576 in patients (=18-75 years) with persistent asthma not adequately controlled with inhaled corticosteroids and long acting ß2-agonists
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 256
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. Signed written informed consent before any assessment is performed, including any adjustments to asthma medication prior to Visit 2.
- •2. Male and female adult patients aged = 18 -75 years.
- •3. Female patients must be:
- •a. surgically sterilized at least 6 months prior to study participation (documentation of
- •sterilization must be provided) or
- •b. postmenopausal (no regular bleeding for at least 1 year), postmenopausal status must be confirmed by plasma FSH level of > 40IU/L at Visit 2
- •Note: A pregnancy test will be done on all female subjects regardless of reported
- •reproductive status at specified time points throughout the study.
- •5. Body mass index (BMI) must be within the range of 18 to 39 inclusive. For tables see Appendix 3.
- •6. Asthma, = 1 years duration diagnosed according to GINA guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2007)
- •7. Daily treatment with > 500µg BDP (>250µg b.i.d.), or equivalent, plus a LABA (b.i.d) (GINA step 4/5 therapy) for = 3 months prior to Visit 2, that has been stable for at least 4 weeks prior to Visit 2.
- •8. Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5 at the end of the screening period (Juniper et al, 2006).
- •9. FEV1 of = 40% and = 80% of the predicted normal value for the patient, after withholding bronchodilators 1.
- •To be included in the induced sputum sub study patients must have an FEV1= 55%
- •predicted at Visits 2 and 3.
- •10. Patients with demonstrated or documented increase of = 12% in FEV1 over their baseline value within 30 minutes of inhaling up to 400/360 µg of salbutamol / albuterol via an MDI after withholding bronchodilators 1,2 (the reversibility test).
- •11. Compliance with Electronic Peak Flow/ ediary device during the screening period* (at the investigators judgment the screening period can be extended to collect 14 days of acceptable ePEF/ediary data)
- •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. Who have smoked or inhaled tobacco products within the 6 month period prior to Visit 2, or who have a smoking history of greater than 10 pack years, (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- •2. Diagnosed with COPD as defined by the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease 2008).
- •3. Who have had an asthma attack/exacerbation requiring a change in maintenance ICS or OCS treatment, or a short burst of systemic corticosteroids, within 6 weeks prior to Visit 2.
- •4. Who have had a respiratory tract infection within 6 weeks prior to Visit 2.
- •5. Who have a medical history (within the 3 months prior to Visit 1) that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
- •6. With a history or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or an AST/ALT or INR of more than 1.5x ULN at Visit 2.
- •7. With history of renal disease or creatinine level above the ULN at Visit 2.
- •8. With fasting triglycerides over 300 mg/dl (3.39 mmol/L) at Visit 2.
- •9. With active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable.
- •10. With a history of schistosomiasis, or stool examination positive for ova or parasites (at Visit 2), or travel to an area endemic with schistosomiasis (in the 6 months prior to Visit 2), including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned until at least 6 months after the last dose.
- •11. With a history of immunodeficiency diseases or hepatitis B or C.
- •12. With a history of hypersensitivity to any ingredients of the study drugs, or drugs related to QAX576 (e.g. monoclonal antibodies, polyclonal gamma globulin, polysorbates).
- •13. Who have had live attenuated vaccinations within 30 days prior to screening visit 2 or during the screening period1.
- •14. Treatments for asthma and allied conditions: the following medications must not be used prior to Visit 2 for at least the minimum washout period specified below or at any time during the study: • Omalizumab or other monoclonal antibody treatment within 4 months prior to Visit 2 • Methotrexate, gold salts, cyclosporin, troleandomycin: 3 months of Visit 2. • Short acting anti-cholinergics within 8 hours prior to Visit 2 • Long acting anti-cholinergics within 7 days prior to Visit 2.
- •15. Maintenance Immunotherapy (desensitization) for allergies is allowed if maintenance dose has been administered for at least 3 months prior to Visit 2, and is expected to remain unchanged throughout the course of the study.
- •16. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives prior to Visit 2, whichever is longer.
- •17. Patients that take acetaminophen (paracetamol) chronically, i.e. more than 1 g/day for more than 3 out of 7 days, or more than 2 g/ day for more than 1 day out of 7 days.
- •18. With a known history of non-compliance to medication or who are unable or unwilling to use Electronic Peak Flow with ediary device or perform spirometry measurements.
- •19. Patients that do not maintain regular day/night, waking/sleeping cycles (e.g. night shift workers will be excluded).
- •20. Patients with a h
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