EUCTR2018-003674-27-CZ进行中（未招募）1 期
A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older with Asthma (DENALI) - DENALI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •For inclusion in the study, subjects must fulfill the following criteria within the screening period:
- •1. Able and willing to provide written informed consent or sign age-appropriate forms; subjects below legal age of consent must have parent(s) or guardian sign the ICF before participation;
- •2 .Female or male aged =4 years at the time of informed consent. In the Czech Republic, Germany, Serbia, Slovakia and Ukraine only subjects = 18 years will be included.
- •3. Diagnosis of asthma as defined by GINA criteria with a documented history of the last 6 months prior to Visit 1;
- •4 Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:
- •(a) Only SABA used prn
- •(b) Stable low-dose ICS in addition to prn use of SABA
- •5. Pre-bronchodilator FEV1 of =50 to <85% predicted normal value for adults (=18 years of age) and =50 % predicted normal value for subjects aged 4 to 17 years after withholding SABA =6 hours at Visit 1. If subject took SABA or any bronchodilator in the morning of Visit 1, either the entire visit must be rescheduled or just PFT assessment rescheduled; Subjects 4 to 17 years of age who previously failed inclusion criteria 5
- •due to the upper FEV1 limit will be permitted to re-screen once and will
- •be required to meet all eligibility criteria upon re-screening.
- •6. Demonstrate reversibility of airflow limitation defined as a =15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a. One re-test for reversibility testing is allowed within the screening period prior to Visit 2;
- •7. Demonstrate acceptable spirometry performance (ie, meet American Thoracic
- •Society/European Respiratory Society [ATS/ERS]) acceptability/repeatability criteria; Subjects 4 to 11 years will be eligible if they provide 2 acceptable / repeatable measurements.
- •8. Taken Ventolin on =2 days out of 7 days prior to Visit 2;
- •9. Willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol;
- •10. Demonstrate acceptable metered-dose-inhaler (MDI) administration technique as assessed by the investigator;
- •11. Able to perform acceptable and reproducible PEF measurements as assessed by the investigator;
- •12. Body mass index (BMI) <40 kg/m2;
- •13. Willing to remain at the study site as required per protocol and complete all visit assessments;
- •14. Negative pregnancy test (serum at Visit 1) for female subjects of childbearing potential;
- •15 Women of childbearing potential and sexually active in heterosexual relationships must agree to 1 of the following options to prevent pregnancy:
- •(a) Practice complete abstinence defined as refraining from heterosexual
- •intercourse during the entire period of risk associated with the study
- •treatments. Periodic abstinence is not acceptable. The reliability of
- •sexual abstinence needs to be evaluated in relation to the duration of the
- •clinical trial and the preferred and usual lifestyle of the subject.
- •Therefore, complete abstinence is an acceptable method of
- •contraception only if it is consistent with the preferred and usual
- •lifestyle of the subject.
- •(b) If a female of childbearing potential agrees to prevent pregnancy by using 1 of the following effective methods of birth control from the date the ICF is signed until 2 weeks after the final dose of IP is taken:
- •i. Hormonal contraception (eg, oral contraceptive, contraceptive implant, or
排除标准
- •Subjects must not enter the study if any of the following exclusion criteria are fulfilled within the screening period:
- •1. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia);
- •2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1;
- •3. Chronic (=3 weeks) use of SCS within 6 months prior to Visit 1;
- •4. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication;
- •5. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana);
- •6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1;
- •7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1;
- •8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1;
- •9. Hospitalizations due to asthma within 6 months prior to Visit 1;
- •10. Have taken =12 actuations per day of Sponsor-provided Ventolin during the run-in period prior to Visit 2 according to the below criteria:
- •(a) =2 days out of 14 days of run-in;
- •(b) =3 days out of 15 to 21 days of run-in;
- •(c) =4 days out of 22 or more days of run-in;
- •11. Unable to comply with study procedures including non-compliance with diary completion;
- •12. Clinically significant laboratory abnormalities, in the opinion of the investigator, or having any of the following results at Visit 1:
- •(a) a serum creatinine value >1.5 times the upper limit of the reference range;
- •(b) a serum total bilirubin value (TBL) >1.5 times the upper limit of the reference range;
- •(c) a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2.5 times the upper limit of the reference range;
- •13. Any of the following results at Visit 1:
- •(a) an abnormal electrocardiogram (ECG) that is, in the investigator’s opinion, clinically significant;
- •(b) a QTCF interval >480 ms (subjects aged =12 years)/=460 ms (subjects aged 4 to 11 years, based on the Fridericia correction where QTcF=QT/RR0.33)
- •14. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinicallysignificant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined
- •as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study;
- •15. Cancer not in complete remission for at least 5 years before Visit 1;
- •16. Hospitalization for psychiatric disorder or attempted suicide within 1
研究者
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