EUCTR2014-002513-27-EE进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, parallel-group, multi-centre 24-week study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe eosinophilic asthma on markers of asthma control - the MUSCA study.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 544
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
- •A subject will be eligible for inclusion in the study only if all of the following criteria
- •1. Age: At least 12 years of age at the time of signing the informed consent/assent.
- •[For those countries where local regulations permit enrolment of adults only, subject recruitment will be restricted to those who are = 18 years of age]
- •2. Inhaled Corticosteroid: A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS).
- •For subjects = 18 years old:
- •- ICS dose must be =880 mcg/day fluticasone propionate (FP) (exactuator) or equivalent daily.
- •- For ICS/LABA combination preparations, the highest approved
- •maintenance dose in the local country will meet this ICS criterion.
- •For subjects = 12 to = 17 years old:
- •- ICS dose must be =440 µg/day FP (ex-actuator) or equivalent daily.
- •- For ICS/LABA combination preparations, the mid-strength approved
- •maintenance dose in the local country will meet this ICS criterion.
- •3. Controller Medication: Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication for at least 3 successive months. [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.]
- •4. Eosinophilic asthma: Prior documentation of eosinophilic asthma or high likelihood of eosinophilic asthma as per Randomisation Criteria 1 and 2 (see Section 5.3 of study protocol).
- •5. FEV1: Persistent airflow obstruction as indicated by :
- •- For subjects = 18 years of age at visit 1, a pre-bronchodilator FEV1 <80% predicted (NHANES III) recorded at Visit 1
- •- For subjects 12-17 years of age at Visit 1:
- •- A pre-bronchodilator FEV1 <90% predicted (NHANES III) recorded
- •at Visit 1 OR
- •- FEV1:FVC ratio < 0.8 recorded at Visit 1
- •6. Exacerbation history: Previously confirmed history of two or more
- •exacerbations requiring treatment with systemic CS (intramuscular (IM), intravenous, or oral), in the 12 months prior to visit 1, despite the use of high-dose ICS. For subjects receiving maintenance CS, the CS treatment for the exacerbations must have been a two-fold dose increase or greater.
- •7. Gender: Male or Eligible Female - To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (Refer to Appendix 5 of study Protocol) for the duration of the trial and for 4 months after the last study drug administration.
- •8. Informed Consent/Assent: Able to give written informed consent/assent prior to participation in the core study, which will include the ability to comply with the requirements and restrictions listed in the consent/assent form and in this protocol.
- •Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
- •Written informed consent must be obtained from ALL patients/legally authorized representative(s); for patients 12-17 years old, written informed assent must be obtained in addition to the legally authorized representative(s)’ consent.
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
- •Inclusion Criteria for the Physical Activity Sub-Study and Physical Activity Sub-Study:
- •A subject will be eli
排除标准
- •A subject will not be eligible for inclusion in the study if any of the following criteria apply:
- •1. Smoking history: Current smokers or former smokers with a smoking history of
- •= 10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked). A former smoker is defined as a subject who quit smoking at least 6 months prior to Visit 1.
- •2. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer.
- •3. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded).
- •4. Liver Disease: Known, pre-existing, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- •5. Cardiovascular: Subjects who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment. Including but not limited to:
- •a. known ejection fraction of <30% OR
- •b. severe heart failure meeting New York Heart Association Class IV (see Appendix 8 of study Protocol) classification OR
- •c. hospitalised in the 12 months prior to Visit 1 for severe heart failure meeting New York Heart Association Class III (see Appendix 8 of study Protocol) OR
- •d. angina diagnosed less than 3 months prior to Visit 1 or at Visit 1
- •6. Other Concurrent Medical Conditions: Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
- •7. Eosinophilic Diseases: Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome (Eosinophilic Granulomatosis with Polyangiitis; EGPA), or Eosinophilic Esophagitis. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 are also to be excluded.
- •8. ECG Assessment:
- •QTc(F) =450msec or QTc(F) =480 msec for subjects with Bundle Branch Block at Visit 1.
- •9. Alcohol/Substance Abuse: A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
- •10. Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus – HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
- •11. Xolair: Subjects who have received omalizumab (Xolair) within 130 days of Visit 1.
- •12. Other Monoclonal Antibodies: Subjects who have received any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
- •13. Investigational Medications: Subjects who have received treatment with an investigational drug within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to Visit 1 (this also includes investigational formulations of marketed products).
- •14. Hypersensitivity: Subjects with allergy/intolerance to a mon
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