ISRCTN17672960已完成1 期
Phase Ib, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety of selnoflast in participants with chronic obstructive pulmonary disease
Roche (Switzerland)0 个研究点目标入组 1 人开始时间: 2021年12月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 14/06/2022:
- •1. Between 35 and 75 years of age (inclusive)
- •2. Participants with >=12-month diagnosis of COPD
- •3. Radiologic evidence of air trapping at screening based on chest HRCT conducted per imaging acquisition protocol and reviewed by the imaging central reader
- •4. Extent of emphysema on HRCT at screening is < 25%
- •5. GOLD 2020 Grade 2/3, characterized by a post-bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <= 0.70 and a post-bronchodilator FEV1 of >=30% and =< 79% of predicted at screening and with an exacerbation history >= 2 or >= 1 leading to hospitalization within the last 12 months
- •6. COPD assessment test (CAT) score >=10 and with a clinical diagnosis of chronic bronchitis, characterized by cough and sputum production on most days for a minimum of 3 months during the last year
- •7. Participant must have a body mass index (BMI) between 18 and 35 kg/m²
- •8. Abnormal laboratory values high sensitivity CRP (hs-CRP) >= 3 mg/L at screening and absolute neutrophil count >= 6.0 x 109/L in whole blood at screening
- •9. Vital signs (body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate) will be assessed in the sitting position after the subject has rested for at least 3 minutes
- •10. Unchanged standard regimen of care for >= 4 weeks prior to screening
- •11. Ex-smokers with at least a 10-pack year smoking history or current smokers with at least a 10 pack-year smoking history who smoke =< 1 pack-year on average in the last 3 months as reported at screening
- •12. Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines
- •13. Female participants: a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: women of non-childbearing potential or women of childbearing potential who agree to remain abstinent or use at least acceptable contraceptive methods during the treatment period and for at least 14 days after the final dose of selnoflast /placebo
- •14. Male participants: No contraception required for male participants
- •Previous inclusion criteria:
- •1. Between 35 and 75 years of age (inclusive)
- •2. Patients with >=12-month diagnosis of COPD
- •3. Radiologic evidence of air trapping at screening based on chest HRCT conducted per imaging acquisition protocol and reviewed by the imaging central reader
- •4. Extent of emphysema on HRCT at baseline is < 25%
- •5. GOLD 2020 Grade 2/3, characterized by a post-bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <= 0.70 and a post-bronchodilator FEV1 of >= 30% and =< 79% of predicted at screening and with an exacerbation history >= 2 or >= 1 leading to hospitalization within the last 12 months
- •6. COPD assessment test (CAT) score >=10 and with a clinical diagnosis of chronic bronchitis, characterized by cough and sputum production on most days for a minimum of 3 months during the last year
- •7. Participant must have a body mass index (BMI) between 18 and 35 kg/m²
- •8. Abnormal laboratory values
- •9. Vital signs (body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate) will be assessed in the sitting position after the subject has rested for at least 3 minutes
- •10. Unchanged standard regimen of care for >= 4 weeks prior to screening
- •11. Ex-smokers with at least a 10
排除标准
- •Current exclusion criteria as of 14/06/2022:
- •1. Any condition or disease detected during the medical interview/physical examination that would render the patient unsuitable for the study, place the patient at undue risk, or interfere with the ability of the patient to complete the study
- •2. Known active or uncontrolled bacterial, viral, fungal, mycobacterial, or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with SARS-CoV-2 within 2 weeks prior to screening
- •3. Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within 6 weeks prior to Day 1
- •4. Diagnosis of severe bronchiectasis in chart or history
- •5. Participants with another concomitant pulmonary disease, including but not exclusive of, interstitial pulmonary fibrosis, sarcoidosis, or other granulomatous or infectious process
- •6. Participants treated for active asthma within 2 years prior to the screening visit
- •7. Any COPD exacerbation or upper or lower respiratory tract infection requiring antibiotics, oral steroids, or hospitalization within 2 weeks prior to screening, during the screening period, or during the run-in period
- •8. Participants requiring long-term oxygen therapy for daytime hypoxemia
- •9. Participants with a diagnosis of alpha-1 antitrypsin deficiency
- •10. History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 5 years
- •11. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
- •12. History of clinically significant ECG abnormalities, or ECG abnormalities at screening
- •13. Known family history or known presence of long QT syndrome
- •14. Participant with a history of acute coronary syndrome in 3 months prior to the screening visit
- •15. Participants with a history of coronary artery bypass surgery or other major vascular surgery within 6 months prior to the screening visit
- •16. Evidence of urinary obstruction or difficulty in voiding
- •17. History of any clinically significant hepatic disease or cirrhosis
- •18. Significant illness not resolved within 2 weeks prior to screening
- •19. Use of systemic steroids, ICS, theophylline, and phosphodiesterase 4 (PDE4) inhibitors within 4 weeks of screening
- •20. Vaccines within 4 weeks prior to the first dose
- •21. Current treatment with medications that are well known to prolong the QT interval
- •22. Donation or loss of 450 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation
- •23. Plasma donation > 150 mL within 7 days prior to first dosing
- •24. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
- •25. History of hypersensitivity to the study drugs or to drugs of similar chemical classes or excipients
- •26. QTcF > 450 ms in male participants and > 470 ms in female participants
- •27. Liver function test abnormalities at screening. Re-testing during the screening period is possible once. This laboratory assessment may be repeated once during the screening period, if necessary
- •28. Anemia (hemoglobin levels >10.0 g/dl at screening). This laboratory assessment may be repeated once during the screening period, if necessary
- •29. Clinical evidence of impaired renal function as indicated by clinically
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