EUCTR2015-001833-26-GB进行中（未招募）1 期
THE EFFECT OF OC000459 ON EOSINOPHILIC AIRWAY INFLAMMATION AND ASTHMA CONTROL IN SUBJECTS WITH REFRACTORY EOSINOPHILIC ASTHMA: A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED TRIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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. Provide written informed consent to participate in the study.
- •2. Be age 18 years and over.
- •3. Show evidence of reversible airflow obstruction documented within the previous 24 months or prior to Randomisation by one of the following measures:
- •airway reversibility (>12% increase in FEV1 and 200ml following 2.5mg nebulised salbutamol),
- •airway hyper-responsiveness (methacholine provocative concentration (PC20) causing a 20% fall in FEV1 of =8 mg/mL),
- •airflow variability in clinic FEV1 =15% between two consecutive clinic visits, or airflow variability as indicated by >20% diurnal variability in PEF observed on 3 or more days.
- •4. Meet the ERS/ATS criteria for severe asthma at Screening:
- •A high dose inhaled corticosteroid and long acting ß2-agonist or leukotriene modifier/theophylline used for the previous year
- •or OCS used for =50% of the previous year.
- •5. Have documented evidence of eosinophilic airway inflammation during the 24 months prior to Screening:
- •an induced sputum eosinophil count =3%;
- •or a peripheral blood eosinophil count =0.25 x 109/l that was related to asthma
- •or an exhaled nitric oxide concentration (FeNO) >50 ppb.
- •6. Have evidence of eosinophilic airway inflammation at Screening as reflected by an induced sputum eosinophil count of =3%.
- •7. Subjects who are taking OCS must be receiving a 20 mg prednisolone equivalent dose or less daily for at least four weeks before the first dose of study drug. The dose of OCS should be unchanged for at least 14 days prior to the Baseline visit.
- •8. Able to comply with the study protocol.
- •9. Women of child bearing potential must have a negative pregnancy test at Screening and on Day 1 and be prepared to use two forms of reliable contraception (hormonal, either oral or implant; intrauterine device; intravaginal barrier device; condom) during the study and for three months thereafter.
- •10. Male subjects with female partners of child bearing potential must agree to take adequate contraceptive precautions for the entire duration of study participation.
- •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 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •1. Treatment with XolairTM or anti-Th2 biologicals within 6 months prior to screening.
- •2. Subjects with clinically significant abnormal serum biochemistry, haematology and urine examination values (not associated with the study indication) within 21 days of the first dose.
- •3. Subjects who have been hospitalised in the last 3 months.
- •4. History of more than 2 episodes of confirmed bacterial lower respiratory tract infection or current lower respiratory tract infection.
- •5. Subjects who are current smokers or have a smoking history of >15 pack years.
- •6. Significant comorbidity that in the Investigator’s opinion is likely to impact the subject’s participation in a 26 week study.
- •7. Presence of a clinically important lung condition other than asthma, e.g. malignancy or previous history of cancer in remission for less than 12 months, clinically important liver or kidney disease, uncontrolled clinically significant cardiovascular or metabolic disease, hypereosinophilic syndromes such as Churg-Strauss Syndrome or eosinophilic oesophagitis.
- •8. Receipt of any of the following medications – more than 1g of paracetamol per day, prednisolone at a dose of more than 20mg per day, regular nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 3 days in the two weeks prior to randomisation.
- •9. A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to screening, or positive drugs of abuse result at screening.
- •10. Participation in another clinical study (observational or interventional) within 3 months of the first dose of study drug or at any time during this study. Studies that require consent only to store data and that do not require follow up are not considered to be observational or interventional and are exempt from this exclusion.
- •11.A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study (see section 6).
- •12.Subjects who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation.
- •13.Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician’s recommendations.
- •14. Subjects with ALT or AST at screening =2xULN.
- •15. Subjects with active hepatitis, chronic active hepatitis or evidence of chronic liver disease (e.g. alcoholic liver disease, fatty liver disease, autoimmune hepatitis, etc.)
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