EUCTR2020-001927-15-CZ进行中（未招募）1 期
A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults with T2-low/non-T2 Severe Uncontrolled Asthma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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. The patient is a man or woman of any ethnic origin, at least 18 years of age at the time of signature of the informed consent form (ICF).
- •b. The patient has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
- •e. The patient has demonstrated =12% and =200 mL response to a bronchodilator from baseline FEV1 within 30 minutes after 4 inhalations of albuterol/salbutamol HFA MDI (90 mcg ex actuator) or equivalent (eg, Ventolin) at screening.
- •f. The patient has asthma with a FEV1 =30% and <80% of the value predicted for age, height, sex, and race at screening. FEV1 must be performed using the office-based spirometer provided for the study. One pulmonary function test retest during the screening visit(s) period (up to 2 weeks) is allowed to fulfill this criterion.
- •For further inclusion criteria, see protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 109
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •a. The patient has any other pulmonary diagnosis that in the opinion of the investigator and/or the clinical study physician could adversely affect patient safety or interpretation of study results. Examples include but are not limited to: chronic obstructive pulmonary disease, chronic bronchitis, or any respiratory condition that requires any chronic antibiotic use (some antibiotics can be immunomodulatory such as macrolides [eg, erythromycin, azithromycin, and clarithromycin]), bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia, and interstitial lung disease (including eosinophilic granulomatosis with polyangiitis [EGPA] which is expressly prohibited), obstructive sleep apnea (sometimes referred to as sleep apnea or Pickwickian Syndrome), and gastroesophageal reflux disease that is not treated with a proton pump inhibitor on a scheduled treatment regimen (not as needed).
- •b. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician.
- •c. The patient has any of the following medical conditions:
- •- Conditions that may mimic asthma (eg, vocal cord dysfunction, hyperventilation, panic attacks, cardiac asthma, uncontrolled gastroesophageal reflux disease [gastroesophageal reflux disease controlled on a stable proton pump inhibitor regimen for at least 1 month may be allowed])
- •- Conditions of immunodeficiency, immunocompromise, and/or conditions requiring immunomodulatory therapy
- •- A history of malignancy within 5 years before screening (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening)
- •- Tested positive for tuberculosis (TB) at screening by the QuantiFERON® TB Gold Test, or had a history of untreated latent or active TB. If the QuantiFERON® TB Gold Test is deemed by the principal investigator to be a false positive, a repeat specimen shall be submitted; if the second test is also positive, the patient screen fails; if the second test is negative, a third test shall be submitted; if the third test agrees with the first test, the patient screen fails; if the third test agrees with second test, the patient is considered to be negative for TB.
- •- Known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening
- •- A history of more than one herpes zoster episode or multimetameric herpes zoster
- •- A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, aspergillosis, Clostridium difficile)
- •- A history of or ongoing chronic or recurrent infectious disease (eg, infected indwelling prosthesis, osteomyelitis, chronic sinusitis)
- •- A suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the initial screening visit. Note: Patients who develop an upper respiratory infection/lower respiratory infection (URI/LRI) during the screening period may rescreen 2 weeks after symptoms resolve subject to local or regional public health directives.
- •- Patients with clinical symptoms that may indicate COVID-19 infection, and/or patients who in the investigator’s opinion were at high risk of exposure to CO
研究者
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