PER-109-20已完成未知
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF BRENSOCATIB ADMINISTERED ONCE DAILY FOR 52 WEEKS IN SUBJECTS WITH NON-CYSTIC FIBROSIS BRONCHIECTASIS – THE ASPEN STUDY
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
入选标准
- •1. Provide their signed stud y informed consent to participate.
- •2. Male or female ≥18 years and ≤85 years of age (inclusive) at screening.
- •3. BMI ≥18.5 at screening.
- •4. Clinical history consistent with NCFBE (cough, chronic sputum production and/or
- •recurrent respiratory infections) that is confirmed by chest CT demonstrating bronchiectasis affecting one or more lobes (confirmation may be based on prior chest CT).
- •a. For each subject, the most recent chest CT scan (but not older than 5 years before the
- •Screening date) will be selected for transfer to the central reading facility for
- •confirmation of the diagnosis of NCFBE.
- •b. If the CT scan cannot be read by the reviewers due to quality issues, a new CT scan
- •will be performed.
- •c. In case a chest CT Scan in the last 5 years is not available, a new chest CT scan must
- •be obtained for confirmation of the diagnosis of NCFBE by the central reading
- •5. Postbronchodilator FEV1 at the Screening Visit ≥30% of predicted normal value, calculated using National Health and Nutrition Examination Survey reference equations and must have an absolute value ≥750 mL.
- •6. Current sputum producer with a history of chronic expectoration of at least 3 months in the past 12 months, and able to provide sputum sample during screening (Visit 1). If a
- •subject is unable to produce sputum spontaneously during screening, the subject will be considered a screen failure. The subject should not undergo a sputum induction procedure
- •during screening to meet inclusion criterion.
- •7. Mucopurulent or purulent sputum color assessed at the Screening Visit by color chart developed by MP Murray (Murray et al., 2009).
- •8. At least 2 pulmonary exacerbations defined by need for antibiotic prescription by a physician for the signs and symptoms of respiratory infections in the past 12 months before the Screening Visit.
- •9. Women must be post-menopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective double barrier contraception (ie, methods that in combination achieve <1% unintended pregnancy rates per year) from Day 1 to at least 90 days after the last dose. Such methods include true abstinence (refraining from heterosexual intercourse during the study); combined
- •(estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation and supplemented with a double barrier (preferably male condom); intrauterine devices; intrauterine hormone-releasing systems; or vasectomized partner. For women ≤45 years of childbearing potential, an additional confirmatory testing of FSH level with a threshold of >40 mIU/mL should be performed
- •to be considered infertile.
- •Note: Abstinence is only considered to be a highly effective method of contraception when this is the preferred and usual lifestyle of a subject. Periodic abstinence (calendar, symptothermal, postovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
- •10. Male subjects with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose. Acceptable methods include true abstinence (refraining from intercourse during the study), combined (estrogen and progestogen
排除标准
- •1. A primary diagnosis of COPD or asthma as judged by the Investigator. Patients with comorbid COPD and/or asthma can be enrolled if bronchiectasis is their primary diagnosis.
- •2. Subjects receiving supplemental oxygen >12 hours per day.
- •3. Bronchiectasis due to cystic fibrosis.
- •4. Current smokers as defined per CDC.
- •5. No evidence of bronchiectasis according to the BE-CT scoring system.
- •6. Known or suspected immunodeficiency disorder, including history of invasive
- •opportunistic infections (eg, TB, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immunecompromised status, as judged by the investigator.
- •7. Known history of HIV infection.
- •8. Established diagnosis of hepatitis B viral infection at the time of screening, or positive for HBsAg at the time of screening.
- •Subjects who have gained immunity for hepatitis B virus infection after vaccination (subjects who are HBsAg-negative, HBsAb-positive, and HBcAb-negative are eligible
- •for the study). Subjects with positive HBcAb are eligible for the study only if hepatitis B virus DNA
- •level is undetectable.
- •9. Established diagnosis of HCV infection at the time of Screening. Subjects positive for hepatitis C antibody are eligible for the study only if HCV RNA is negative.
- •10. Currently being treated for NTM lung infection, allergic bronchopulmonary aspergillosis, or TB.
- •11. Active and current symptomatic infection by COVID-19.
- •12. Unable to perform technically acceptable spirometry that meet the ATS/ERS acceptability criteria with at least 3 acceptable flow-volume curves, at least 2 of which meet the ATS/ERS repeatability criteria for FEV1 during Screening.
- •13. Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
- •14. Receiving medications or therapy that are prohibited as concomitant medications (see Section 5.3 for prohibited concomitant medications).
- •15. Started oral or inhaled antibiotics as chronic treatment for NCFBE for <3 months prior to the Screening visit.
- •a. Subjects on antibiotics as chronic treatment should be on such treatment for at least 3 months prior to enrollment while meeting all other inclusion criteria and none of the
- •exclusion criteria.
- •16. Chronic treatment with oral steroids (irrespective of the indication).
- •17. Subjects who have adjustments to their baseline medications within 1 month before
- •Screening; they can be rescreened a month after the new treatment has been initiated.
- •18. Abnormal renal function test result (estimated glomerular filtration rate <30 mL/min by
- •Chronic Kidney Disease - Epidemiology Collaboration equation formula) at Screening.
- •19. Active liver disease or hepatic dysfunction manifested as follows:
- •a. Elevated liver function test results (ALT or AST >2 × ULN).
- •b. Bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •c. Known hepatic or biliary abnormalities, not including Gilbert´s syndrome or asymptomatic gallstones.
- •20. History of malignancy in the past 5 years, except completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin.
- •21. Previously participate
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