EUCTR2015-002656-26-GB进行中（未招募）1 期
A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects with Asthma. - RSPR-008
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
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
入选标准
- •1. Written informed consent must be obtained before any trial related procedures are
- •2. Age =18 years old
- •3. Diagnosis of asthma according to GINA Guidelines (1)
- •4. Atopic phenotype as assessed by Investigator based on:
- •o Positive skin prick test or
- •o Positive specific IgE test or
- •o Medical history
- •5. Treated with ICS and LABA for at least 12 weeks prior to Visit 1 with a daily ICS dose equivalent to =400µg and =800µg budesonide and a daily stable LABA dose.
- •6. Blood eosinophils =0.05*109/L at Visit 1
- •7. Demonstration of FEV1 =60% of the predicted value at Visit 1
- •8. Demonstration of ACQ6 = 0.5 and =2.5 at Visit 1
- •9. Reversibility of at least 12% and 200 mL in FEV1 after 200 µg to 800 µg of Salbutamol Dry Powder Inhaler (DPI) or 400 mg Salbutamol via pressurised metered dose inhaler (pMDI) with or without spacer at Visit 1 or Visit 2. Note: SABA should be withheld 8 hours and ICS/LABA 24 hours before the reversibility test
- •10. Ability to use Turbuhaler® correctly
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Lower respiratory tract infection <6 weeks prior to Visit 1
- •2. Current smokers
- •3. Ex-smokers with a smoking history of >10 pack years (e.g. 10 pack years = 1 pack/day x
- •10 years, or ½ pack/day x 20 years). An ex-smoker may be defined as a subject who has
- •not smoked for >6 months prior to Visit 1
- •4. Treatment with any of the medications listed below <6 weeks prior to Visit 1:
- •o Systemic (oral or parental) corticosteroids
- •o Any systemic immunomodulatory therapy introduced <6 months prior to Visit 1
- •o Any treatment with biologics
- •5. BMI which is judged by the investigator to interfere with trial procedures and results
- •6. Known HIV positive
- •7. Known active hepatitis B or C
- •8. Significant concurrent, uncontrolled medical condition including, but not limited to,
- •renal, hepatic, cardiac, haematological, gastrointestinal, endocrine, inflammatory, autoimmune, pulmonary, neurological, cerebral or psychiatric disease evaluated by the Investigator to interfere with effect of the trial drug
- •9. Subjects who have a clinically significant abnormal laboratory value except blood eosinophils at Screening (Visit 1) and would be at potential risk if enrolled in the trial as
- •evaluated by the Investigator
- •10. Known uncontrolled allergic conditions or allergy/hypersensitivity to any component of the trial drug or placebo excipients
- •11. Pregnant and breast-feeding female subjects
- •12. Female subjects of childbearing potential not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local requirements or practice)
- •during participation in the trial until at least 3 days after last intake of IMP
- •13. Male subjects not surgically sterilised, who or whose partner is not using adequate
- •contraceptive methods (adequate contraceptive measures as required by local
- •requirements or practice) during participation in the trial until at least 3 days after last
- •intake of IMP
- •14. Receipt of any experimental agents within 30 days prior to Visit 1
- •15. Participation in any other interventional clinical trial during the trial period
- •16. Parasitic infection within 6 months prior to Screening
- •17. Travels to parasitic endemic areas within 6 months prior to Screening
- •18. Subjects known or suspected of not being able to comply with the trial-related procedures
- •(due to e.g. alcoholism, psychiatric disorder, language problems)
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