ISRCTN15988757进行中（未招募）2 期
A pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial, incorporating an internal pilot, to determine the role of bronchodilators in preventing exacerbations of bronchiectasis
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 600 人开始时间: 2020年5月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37562935/ (added 14/08/2023)
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 05/09/2022:
- •1. Adult patients with CT-scan-confirmed bronchiectasis and bronchiectasis is the predominant primary respiratory disease in the view of the investigator (CT images/CT reports must be available to complete radiological scoring for BSI)
- •2. History of 2 or more exacerbations in any 12-month period in the preceding 2 years requiring antibiotics and/or steroids
- •3. Evidence of airflow limitation with an FEV1/FVC ratio less than 0.7 and/or daily mucus expectoration
- •4. Have either:
- •4.1. Less than 20 pack-year history of smoking OR
- •4.2. Greater than 20 pack-year history of smoking with an FEV1 >79% predicted (to exclude COPD)
- •5. For patients taking ICS, LAMA or LABA treatment prior to recruitment, willing to have these treatments changed or stopped
- •6. Stable bronchiectasis with no exacerbations for 4 weeks prior to baseline
- •7. Stable dose of oral steroid for 4 weeks prior to baseline (only applicable for patients taking oral steroid as part of standard care)
- •Previous inclusion criteria:
- •1. Adult patients with CT scan confirmed bronchiectasis and bronchiectasis is the predominant primary respiratory disease in the view of the investigator (CT images / CT reports must be available to complete radiological scoring for BSI)
- •2. History of 3 or more exacerbations in the preceding 12 months requiring antibiotics and/or steroids
- •3. Evidence of airflow limitation with an FEV1/FVC ratio less than 0.7 and/or daily mucus expectoration
- •4. Have less than 20 pack-year history of smoking
- •5. Willing to have baseline treatment altered / ICS etc. stopped if already taking
- •6. Stable for 4 weeks prior to baseline
- •7. Stable dose of oral steroid for 4 weeks prior to baseline (only applicable for patients taking oral steroid as part of standard care)
排除标准
- •Current exclusion criteria as of 05/09/2022:
- •1. Cystic fibrosis-related bronchiectasis
- •2. Where bronchiectasis is not the main disease or there are contraindications to ICS withdrawal
- •3. Predominant COPD or asthma. (Patients who have a historical diagnosis of asthma and/or COPD but where the investigator has sufficient evidence to refute these diagnoses can still be included. This is to be documented in the source and the CRF.)
- •4. Indication to remain on ICS (e.g. asthma, COPD, allergic bronchopulmonary aspergillosis, inflammatory bowel disease) or known intolerance to any of the trial drugs or their ingredients
- •5. Patients with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- •6. Inability to perform spirometry or quality of life questionnaires
- •7. Patients who are:
- •7.1. Pregnant
- •7.2. Breastfeeding
- •7.3. Of childbearing potential with a positive urine pregnancy test prior to starting trial IMP
- •7.4. Male or female of childbearing potential unwilling to use contraception throughout the trial (postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
- •8. Anyone with cognitive impairment who may not be able to consent
- •9. Those who do not speak English or cannot comply with trial procedures
- •10. Any potential participant who the investigator believes will not be able to complete the study visits and procedures
- •11. A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, ß2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator contraindicates study participation
- •12. Use of acute antibiotics or systemic steroids within 4 weeks of baseline
- •13. Malignancy diagnosed within 5 years of the first trial medication administration where the investigator feels the trial may be affected by recurrence or progression of the malignancy (e.g. patients with stable breast cancer, current prostate cancer or 'expected curative' cancer surgery may not be excluded at the investigator's discretion)
- •14. Administration of an investigational agent within 30 days of first dose of trial medication
- •Previous exclusion criteria:
- •1. Cystic fibrosis related bronchiectasis
- •2. Where bronchiectasis is not the main disease or there are contraindications to ICS withdrawal
- •3. Predominant COPD or asthma (Patients who have a historical diagnosis of asthma and/or COPD but where the investigator has sufficient evidence to refute these diagnoses can still be included. This is to be documented in the source and the CRF)
- •4. Indication to remain on ICS (e.g. asthma, COPD, allergic bronchopulmonary aspergillosis, inflammatory bowel disease) or known intolerance to any of the trial drugs or their ingredients
- •5. Inability to perform spirometry or quality of life questionnaires
- •6. Patients who are:
- •6.1. Pregnant
- •6.2. Breastfeeding
- •6.3. Of childbearing potential with a positive urine pregnancy test prior to starting trial IMP
- •6.4. Male or female of childbearing potential unwilling to use contraception throughout the trial
- •(postmenopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential).
- •7. Anyone with cognitive impairment who may not be able to consent
- •8. Those who do not speak English or cannot comply with trial procedures
- •9. Any potential partici
研究者
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