PER-034-19招募中未知
A PHASE IIA, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF MTP9579A IN PATIENTS WITH ASTHMA REQUIRING INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 6
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
- •-Signed Informed Consent Form
- •- Ability to comply with the study protocol, in the investigator´s judgment.
- •- Age 18 - 75 years, inclusive, at the time of signing the Informed Consent Form.
- •- Body mass index of 18-38 kg/m2 and weight ≥ 40 kg at screening.
- •- Documented physician-diagnosed asthma for at least 12 months prior to screening.
- •- Pre-bronchodilator FEV1 40%-80% predicted at screening
- •- Post-bronchodilator reversibility of FEV1 (liters) 12% and 200 mL at screening
- •- Treatment with asthma controller therapy (daily ICS [≥ 100 µg of fluticasone propionate or equivalent] and at least one additional controller therapy [LABA, LAMA, LTM/LTRA]) for ≥ 3 months prior to screening, with no changes within 4 weeks prior to screening or during the screening period and no anticipated changes in controller dosing regimens throughout the Study.
- •- ACQ-5 score ≥ 1.5 at screening.
- •- Documented history (e.g., medical report, pharmacy prescription assessed by investigator) of ≥ 1 asthma exacerbation within the 12 months prior to screening while on daily ICS maintenance therapy (same or higher dose as at screening).
- •- Demonstration of acceptable inhaler, peak flow meter, and spirometry techniques at screening.
- •- Demonstrated compliance with required use of the eDiary, as defined in the protocol.
- •- - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined in the protocol.
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined in the protocol.
排除标准
- •- History or evidence of vocal cord dysfunction, reactive airways dysfunction syndrome, hyperventilation associated with panic attacks, or other mimics of asthma.
- •- History or evidence of significant respiratory disease other than asthma, including occupational asthma, aspirin-sensitive asthma, asthma-chronic obstructive pulmonary disease (COPD) overlap syndrome, bronchiolitis, interstitial lung disease, or COPD.
- •- Current smoker, former smoker with smoking history of ˃ 10 pack-years, or unwilling to abstain from smoking from the time of consent through the completion of the study
- •- History or evidence of substance abuse that, in the investigator’s judgment, would affect the patient’s ability to participate in the study, pose a risk to patient safety, interfere with the conduct of the study, or have an impact on the study results.
- •- History or evidence of any clinically significant medical condition/disease (e.g., psychiatric, neurologic, cardiovascular, renal, hepatic, gastrointestinal, endocrine, autoimmune) or abnormalities in laboratory tests that, in the investigator´s judgment, precludes the patient’s safe participation and completion of the study, or interferes with the conduct and interpretation of the study.
- •- Hemoglobin A1c (HbA1c) ˃ 8.5% at screening or any other clinically significant finding that, in the opinion of the investigator, may define uncontrolled diabetes.
- •- Myocardial infarction, unstable angina pectoris, or stroke within 12 months prior to screening.
- •Any chronic heart failure exacerbation within 12 months prior to screening or at risk for heart failure exacerbation in the investigator’s opinion.
- •- History or presence of an abnormal ECG that is clinically significant in the investigator´s opinion, including complete left bundle branch block, second- or third degree atrioventricular heart block, or evidence of prior myocardial infarction.
- •- QT interval corrected through use of Fridericia´s formula (QTcF) ˃ 450 ms, if patient is male, or QTcF ˃ 470, if patient is female, demonstrated by at least two ECGs ˃30 minutes apart.
- •- Active malignancy or history of malignancy within 5 years of screening, except for appropriately treated non-melanoma skin carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or Stage I uterine cancer.
- •- Positive for hepatitis C virus (HCV) antibody at screening, unless HCV RNA ˂ 15 IU/mL (or undetectable) at screening and for 6 months if successfully completed HCV anti-viral treatment.
- •- Positive hepatitis B surface antigen (HBsAg) at screening, or:
- •Negative HBsAg and positive hepatitis B core antibody (HBcAb); with a positive hepatitis B virus (HBV) DNA test.
- •- Positive HIV antibody at screening
- •- Positive for TB during screening, defined as either a positive purified protein derivative (PPD) test (≥5 mm of induration 48-72 hours after injection) or a positive QuantiFERON®TB Gold (QFT-G) test during screening:
- •For patients with a history of bacille Calmette-Guerin (BCG) vaccination, the criteria for the QFT-G apply as defined in the protocol.
- •Patients with a positive PPD test or QFT-G are eligible if they meet all of the criteria defined in the protocol for these cases.
- •- Acute infection requiring either surgical intervention (e.g., drainage) or medical therapy (e.g., antibiotics) within 4 weeks prior to screening.
- •- Active para
研究者
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