EUCTR2017-003679-75-GB进行中（未招募）1 期
A randomised, double-blind, placebo-controlled study, in COPD patients with and without a confirmed respiratory virus infection assessing anti-viral biomarker responses and clinical effects of inhaled SNG001 compared to placebo. - Inhaled SNG001 in COPD patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
入选标准
- •1. Male or female, between and including 40-75 years of age, at the time of the screening visit.
- •2. A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the screening visit.
- •3. Post bronchodilator FEV1/FVC ratio <0.7.
- •4. Post bronchodilator FEV1 =40% of predicted (at screening and post sputum induction pre-dose).
- •5. Should have stable COPD, having no symptoms of an exacerbation and/or respiratory tract infection currently and/or within the past 6 weeks of screening and/or randomisation.
- •6. Should be prescribed and taking regularly one or more long acting bronchodilator (e.g. long acting ß2 agonist (LABA), long acting muscarinic antagonist [LAMA]) with or without an inhaled corticosteroid maintenance therapies for their COPD.
- •7. Patients who produce sputum most days.
- •8. Provide written informed consent.
- •9. The patient produced an adequate sputum sample at the screening visit.
- •10. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception. Acceptable birth control methods are stated in the protocol. Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled IFN-ß-1a/matching placebo. In addition to the acceptable birth control method (except for the practice of total sexual abstinence), condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-ß-1a/matching placebo to prevent pregnancy.
- •Women not of childbearing potential are defined in the protocol.
- •11. Motivation (in the Investigator’s opinion) to comply with protocol requirements and complete all study visits, including the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment (including its risks and potential benefits).
- •1. Male or female, between and including 40-85 years of age at the time of the consent visit.
- •2. A confirmed physician diagnosis of COPD or a medical history consistent with a diagnosis of COPD for at least 12 months prior to the consent visit.
- •3.Post bronchodilator FEV1/FVC ratio <0.7.
- •4. Post bronchodilator FEV1 =30% of predicted.
- •5. To have had 1 or more COPD exacerbations in the last 12 months requiring intervention with oral corticosteroids and/or antibiotics.
- •6. Patient reported evidence that a respiratory virus has made their COPD significantly worse in the past.
- •7. Patients who have chronic bronchitis OR produce sputum on most days.
- •8. Should be prescribed and taking regularly one or more long acting bronchodilator (e.g. LABA, LAMA) with or without an inhaled corticosteroid mainte nance therapy for their COPD.
- •9. Patients on self-management plans agree to consult a healthcare professional prior to taking oral corticosteroids or antibiotics for treatment of a COPD exacerbation.
- •10. Provide written informed consent
排除标准
- •1. Any condition, including findings in the medical history or in the pre-randomisation assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
- •2. Current treatment or treatment within the past 6 weeks with oral corticosteroids or other systemic immunosuppressive.
- •3. Oxygen saturation of = 92%.
- •4. Patients who require any form of oxygen therapy or non-invasive ventilation.
- •5. The patient has received live vaccines in the past six weeks prior to randomisation or attenuated vaccines in the past two weeks prior to randomisation.
- •6. Current or previous participation in another clinical trial where the patient has received a dose of an investigational medicinal product (IMP) containing small molecules within 12 weeks prior to entry into this study or containing biologicals within 12 months prior to entry into this study.
- •7. Active interstitial lung disease or past history of lung cancer not considered cured, significant bronchiectasis, cystic fibrosis, alpha1 antitrypsin deficiency or a history of significant chronic asthma.
- •8. Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact the interpretation of results (see protocol for examples)
- •9. History of hypersensitivity to natural or recombinant IFN-ß or to any of the excipients in the drug preparation.
- •10. Significant history of depressive disorder or suicidal ideation. Specifically, individuals with current severe depression (see protocol for examples) individuals with a past history of depression that required hospitalisation or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past.
- •11. Patients who are currently receiving anti-epileptic therapy and/or have uncontrolled epilepsy.
- •12. History of drug or alcohol abuse within 12 months prior to enrolment.
- •13. Female who is breast-feeding, pregnant or intends to become pregnant.
- •14. Patients with clinically significant arrhythmias or implantation of permanent pacemaker or implanted cardiac defibrillator
- •15. Patients with unstable ischaemic heart disease (including, but not limited to, unstable angina, myocardial infarction within the preceding 6 months).
- •1. Any condition, including findings in the medical history or in the pre-study assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation.
- •2. The patient currently has or has had any of the following within the past 6 weeks:
- •a. A moderate or severe exacerbation of COPD (Appendix A: Exacerbations definitions (GOLD 2017)).
- •b. An upper or lower respiratory tract infection
- •Note: there should be at least 6 weeks between the resolution of any of the above and the patient entering the study.
- •3. Oxygen saturation of =92%.
- •4. Patients who re
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