CTIS2023-508706-23-00进行中（未招募）1 期
Phase 1/2a Trial to Evaluate the Safety, Tolerability and Efficacy of Nebulised RESP30X Nitric Oxide Formulations in Non-Cystic Fibrosis Bronchiectasis (NCFB) Patients with Pseudomonas Aeruginosa (Pa) or other Potentially Pathogenic Micro-organisms (PPMs). - RESP30X-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Provide written, informed consent prior to all study-related procedures and agree to undergo all study procedures., 2. Aged between 18 and 75 years, inclusive., 3. Clinical history of bronchiectasis affecting 1 or more lobes based on symptoms (cough, sputum productive and/or recurrent lower respiratory tract infections) as confirmed by historical computerised tomography (CT) scan and radiology report performed within the last 5 years., 4. Confirmed high-titre respiratory PPMs at screening (as determined by central laboratory microbiological cultures). a) Part 1: =10^6 CFU/mL b) Part 2: =10^5 CFU/mL, 5. Individuals of childbearing potential and their partners who engage in heterosexual intercourse must agree to use protocol defined method(s) of contraception., 6. Individuals who can produce spontaneous sputum on a daily basis., 7. Individuals who are able to self-administer the study supplied SABA inhaler and nebuliser effectively in the Investigator’s opinion, following training.
排除标准
- •1. Currently receiving therapy with any inhaled antibiotic therapy. Patients who have previously received inhaled antibiotic therapy may be eligible if therapy was discontinued at least 7-days prior to screening., 19. Known allergy to active substance or any excipients or to auxiliary product., 20. Known hypersensitivity to NO., 2. Treatment with systemic anti-infective within 7-days prior to screening. Treatment with Azithromycin may be permitted only if in accordance with Protocol Section 4.4.1., 21. History of anaphylaxis to any medication or hospitalisation due to an adverse drug reaction., 22. Participants who are pregnant or breast-feeding., 23. Participants planning to conceive a child within the anticipated period of study participation and for at least 90 days after the last dose of IMP in the study., 24. Participants with the following toxicities at screening as defined by the enhanced CTCAE toxicity table version 5.0, 27Nov2017. See protocol., 25. Baseline-corrected QTcF >450 msec (males) or 470 msec (females) or history of congenital long QT syndrome, Torsades de Pointes or other clinically significant abnormal ECG at Screening or Baseline., 26. History of solid organ transplantation., 27. History of malignancy or treatment for malignancy within the past year., 10. Taking medications that may induce methaemoglobinaemia or have received these within 30 days of screening., 3. Participation in other clinical studies with investigational agents within 8 weeks prior to screening., 4. Treatment with NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening., 5. Treatment with immunosuppressive medications within 2 weeks prior to screening, or systemic corticosteroids for 7 days within 2 weeks prior to screening., 6. HIV positive AND: •CD4 < 350 cells/mm3, 7. FEV1 <50% predicted at the screening visit., 8. Significant haemoptysis within 60 days of screening defined as an estimated volume of 50ml in a single occurrence., 9. History of methaemoglobinaemia., 13. In the opinion of the investigator, patients with an acute exacerbation of NCFB, 11. Baseline MetHb concentration (using fingertip sensor) >3%., 12. Current smokers of tobacco products, marijuana, e-cigarettes/vaping., 14. In the opinion of the investigator, any other clinically relevant active disease with the potential to compromise subject safety or confound interpretation of safety or efficacy outcomes., 15. Asthma which requires treatment with Global Initiative for Asthma steps 4–5 suggested medications for the previous year, or systemic corticosteroids for =50% of the previous year., 16. Patients with a current diagnosis of pulmonary TB based on clinical testing or symptoms. Patients with a history of pulmonary TB who have completed a course or eradication therapy at least 2 years prior to screening may be eligible if there is no clinical suspicion of recurrence. Participants with latent pulmonary TB are eligible provided they have received adequate treatment per local country guidelines., 17. Participants with a diagnosis, or suspected diagnosis, of Nontuberculous mycobacteria infection. Participants with a previous positive culture that is suspected to be a contaminant are eligible., 18. Conditions of increased risk for MetHb formation, significant anaemia or haemoglobinopathy.
研究者
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