ISRCTN89040295进行中（未招募）未知
A 2x2 factorial randomised open label trial to determine the CLinical and cost-Effectiveness of hypertonic saline (HTS 6%) and carbocisteine for Airway cleaRance versus usual care over 52 weeks in bronchiectasis
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 288
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31856887 protocol (added 23/12/2019)
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 06/10/2022:
- •1. Diagnosis of BE on high resolution computed tomography (HRCT)/computed tomography (CT) scans
- •2. BE must be the primary respiratory diagnosis
- •3. One or more pulmonary exacerbations in the last year requiring antibiotics*
- •4. Production of daily sputum
- •5. Stable for 14 or more days before the first study visit with no changes to treatment
- •6. Willing to continue any other existing chronic medication throughout the study
- •7. Female subjects must be either surgically sterile, postmenopausal or agree to use effective contraception during the treatment period of the trial
- •*This can include patient-reported exacerbations
- •Previous inclusion criteria:
- •1. Diagnosis of BE on high resolution computed tomography (HRCT)/computed tomography (CT) scans
- •2. BE must be the primary respiratory diagnosis
- •3. Two or more pulmonary exacerbations in the last year requiring antibiotics*
- •4. Production of daily sputum
- •5. Stable for 14 or more days before the first study visit with no changes to treatment
- •6. Willing to continue any other existing chronic medication throughout the study
- •7. Female subjects must be either surgically sterile, postmenopausal or agree to use effective contraception during the treatment period of the trial
- •*This can include patient-reported exacerbations
排除标准
- •1. Age <18 years old
- •2. Patients with CF
- •3. Patients with COPD as a primary respiratory diagnosis
- •4. Current smokers, female ex-smokers with greater than 20 pack years and male ex-smokers with greater than 25 pack years
- •5. FEV1<30%
- •6. If being treated with long term macrolides, on treatment for less than 1 month before joining study
- •7. Patients on regular isotonic saline
- •8. Treatment with HTS, carbocisteine or any mucolytics within the past 30 days
- •9. Known intolerance or contraindication to HTS or carbocisteine.
- •10. Hypersensitivity to any of the active ingredients or the excipients of carbocisteine
- •11. Active peptic ulceration
- •12. Any heredity galactose intolerance, the Lapp-Lactase deficiency or glucose-galactose malabsorption.
- •13. Patients unable to swallow oral capsules.
- •14. Women who are pregnant or lactating
- •15. Participation in another Clinical Trial of an Investigational Product within 30 days
研究者
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