PER-050-18已完成未知
A 52-WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLEDUMMY, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY OF FEVIPIPRANT ONCE DAILY PLUS STANDARD-OF-CARE (SOC) FORREDUCTION OF SYSTEMIC CORTICOSTEROIDS (ORAL AND PARENTERAL) USE IN PATIENTS WITH SEVERE ASTHMA
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 17 人开始时间: 2019年2月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 17
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. Signed informed consent.
- •2. Male and female patients ≥18 years
- •3. Patients with a diagnosis of asthma for a period of at least 3 months prior to Screening
- •Visit with current asthma severity step 4 or 5 (GINA 2018)
- •4. Currently on treatment with medium or high dose ICS/LABA +/- other controller for a minimum of 6 weeks prior to Screening Visit.
- •5. At screening, patients with FEV1 of ≤80% of the predicted normal value for the patient, after withholding bronchodilators at Screening Visit and beginning of Run-InVisit .
- •6. An increase of ≥12% and ≥200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of salbutamol/albuterol prior to randomization (documented historical reversibility is accepted).
- •7. Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at Screening Visit and Treatment Day 1 Visit.
- •8. Documented history of at least 1 asthma within 1 year prior to enrolment.
排除标准
- •1. Asthma exacerbation, within 6 weeks prior to enrolment that required SCS, hospitalization, or emergency room visit.
- •2. Chronic/ maintenance use of OCS for asthma.
- •3. Prior use of biologics.
- •4. Any contra-indications of SCS use.
- •5. Pregnant or nursing (lactating) women.
- •6. Women of child-bearing potential, unless they are using methods of
- •7. Use of other investigational drugs.
- •8. Hypersensitivity to any of the study drugs.
- •9. History of malignancy of any organ system.
- •10. Patients who have smoked or inhaled any substance other than asthma medications
- •11. Patients requiring SCS use for conditions other than asthma
- •12. Patients with a history of chronic lung disease other than asthma,sarcoidosis, interstitial lung disease, cystic fibrosis, and active tuberculosis
- •13. Patients with history of alcohol or drug abuse
- •14. Patients with a known history of non-compliance to medication or unable/unwilling to complete an electronic patient diary or Electronic Peak Flow with eDiary device
- •15. Patients who have had a respiratory tract infection or asthma worsening
- •16. Patients with any chronic condition of the respiratory tract
- •17. Patients who have a clinically significant laboratory abnormality
- •18. Serious co-morbidities
- •19. Patients receiving any prohibited medication
- •20. Patients who started immunotherapy or desensitization for allergies
- •21. Inability to comply with all study requirements and demonstrate good medication compliance
- •22.Any medical or psychological condition that renders the patient unable to understand the nature, scope, and possible consequences of the study
- •23. Patients with a history of being unable to swallow tablets
- •24. Patients who have received immunomodulator or immumomodulatory drugs or any experimental anti-inflammatory therapies
- •25. Current treatment for hepatic disease
- •26. History of immunodeficiency disease or hepatitis B or hepatitis C
- •27. Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2mg of pitavastatin
- •28. Patients on any statin therapy with a CK level >2 X ULN
- •29. Patients on rifampin, probenecid, ritonavir and valproic acid
- •30. No person directly associated with the administration or study site family member is allowed to participate
- •31. History of lactose or milk sensitivity
- •32. Conditions other than asthma that could result in elevated eosinophils
- •33. Diagnosis of ECG abnormalities indicating significant
- •34. Patients with a resting QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female)
- •35. Use of agents with known risk of TdP
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