ISRCTN15449782进行中（未招募）未知
The microbial effect of inhaled steroids in severe COPD patients with associated bronchiectasis (TEMPESTAS)
The University of Edinburgh & Lothian Health Board0 个研究点目标入组 80 人开始时间: 2022年2月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. Informed Consent: A signed and dated written informed consent prior to study participation.
- •2. Type of subject: Outpatient.
- •3. Age: Subjects 40 years of age or older at screening visit.
- •4. Gender: Male or female subjects.
- •5. COPD Diagnosis: An established clinical history of COPD as documented in medical notes in accordance with the definition by the American Thoracic Society/European Respiratory Society. COPD-Bronchiectasiscoexistence: smoking history of greater than 10 pack year, with a post bronchodilator FEV1/FVC ratio <0.7 with coexistent bronchiectasis on a high-resolution CT Chest (increased broncho-arterial ratio in two or more lobes of the lung). CT scans would have been done prior to recruitment as a part of usual clinical pathway.
- •5.1 Two or more exacerbations in the last 1-year (requiring antibiotics and/steroids) or one or more hospitalisation in accordance with GOLD D (2017) classification (high risk more symptom COPD patients) but clinically stable during screening period.
- •5.2 Clinically stable is defined as not requiring antibiotics and or steroid 4 weeks prior to study entry. This will be checked during the randomisation visit from patient history and documented by the research nurses.
- •6. Smoking history: Current or former cigarette smokers (cigarettes or rolled tobacco) with a history of cigarette smoking of >10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history.
排除标准
- •1. Pregnancy: Women who are pregnant or breast feeding or are planning on becoming pregnant during the study.
- •2. Asthma: Subjects with a current/ concurrent diagnosis of asthma.
- •3. a1-antitrypsin deficiency: Subjects with known a1-antitrypsin deficiency as the underlying cause of COPD.
- •4. Other respiratory disorders: Subjects with active tuberculosis, active lung cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, or other interstitial lung diseases.
- •5. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening.
- •6. Risk Factors for Pneumonia: immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia, when patients are on long standing immunosuppressive drugs or have neuromuscular conditions affecting control of the upper airway, such as Parkinson’s disease, Motor Neuron Disease or Myasthenia Gravis.
- •7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the washout period will be excluded.
- •8. Other Respiratory tract infections that have not resolved at least 7 days prior to screening including COVID19 infections
- •9. Other diseases/abnormalities: Subjects with historical or current evidence of any of the following clinically significant abnormalities that are uncontrolled:
- •9.1. cardiovascular
- •9.2. neurological
- •9.3. psychiatric (including documented psychiatric reactions or hypersensitivity to oral steroids)
- •9.4. renal
- •9.5. hepatic
- •9.6. immunological
- •9.7. gastrointestinal
- •9.8. urogenital (e.g. significant prostatic hyperplasia/bladder outflow obstruction)
- •9.9. nervous system
- •9.10. musculoskeletal (including known significant osteoporosis)
- •9.11. skin
- •9.12. sensory
- •9.13. endocrine (including uncontrolled Type 1 or 2 diabetes or thyroid disease)
- •9.14. ocular (e.g. significant narrow angle glaucoma)
- •9.15. haematological
- •10. Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, oesophageal or gastric varices or persistent jaundice.
- •11. Unstable or life-threatening cardiac disease
- •12. Abnormal and clinically significant 12-Lead ECG finding
- •13. Other Contraindications: A history of allergy or hypersensitivity to any oral steroid or corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, uncontrolled symptomatic prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation.
- •14. Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, prostrate carcinoma, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5year waiting period if the subject has been considered cured by treatment.
- •15. Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3L/min (Oxygen use up to 3L/min flow is not exclusionary.)
- •16. Medication prior to spirometry: Subjects who are medically unable to withhold their salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
- •17. Pulmonary rehabilitation: Subjects who have participate
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