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临床试验/ACTRN12621001122842
ACTRN12621001122842进行中(未招募)未知

Effect of domiciliary humidified nasal high flow air on airway inflammation markers in bronchiectasis: a randomised, cross-over study.

Fisher and Paykel Healthcare0 个研究点目标入组 15 人开始时间: 2021年8月23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
15

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Aged 18 years or over, Able to provide written informed consent, Able to provide spontaneous sputum samples, High-resolution CT (HRCT) chest scan confirming diagnosis of bronchiectasis, within the past 5 years, Clinically stable during baseline period, for 4 weeks prior to commencement of, treatment (defined as the absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone, with stable spirometry), History of one or more pulmonary exacerbations requiring antibiotics in the past 12 months. Patients with asthma and COPD will be included only if the primary diagnosis is bronchiectasis.; Aged 18 years or over, Able to provide written informed consent, Able to provide spontaneous sputum samples, High-resolution CT (HRCT) chest scan confirming diagnosis of bronchiectasis, within the past 5 years, Clinically stable during baseline period, for 4 weeks prior to commencement of, treatment (defined as the absence of clinical worsening beyond normal daily variation, with no need for increasing habitual medications or taking antibiotics or prednisone, with stable spirometry), History of one or more pulmonary exacerbations requiring antibiotics in the past 12 months. Patients with asthma and COPD will be included only if the primary diagnosis is bronchiectasis.

排除标准

  • Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic treatment within 4 weeks prior to commencing study treatment. Patients with a history of non-compliance with treatment/management. Patients with significant medical conditions other than bronchiectasis: A significant disease is one that would, in the opinion of the investigator, put the participant at risk through participation in the study, or a disease that may influence the results of the study, or the participant’s ability to participate in the study. Patients with cystic fibrosis. Patients with primary ciliary dyskinesia. Patients with hypogammaglobulinaemia. Patients with allergic bronchopulmonary aspergillosis (total IgE greater than 420 IU/ml Aspergillus specific IgE level of 3+ or 4+, and proximal bronchiectasis on HRCT). Patients taking immunosuppressive agents (e.g., azathioprine, methotrexate, cyclophosphamide) or long term corticosteroid therapy. Patients with other primary or acquired immunodeficiency. Patients on long term oxygen therapy. Patients with evidence of active or suspected cancer and patients having undergone cancer treatment including resection, radiation therapy or chemotherapy within the last 2 years (patients with basal cell carcinoma and squamous cell carcinoma are allowed). Pregnant or lactating women. Participation in a separate clinical or device trial within 4 weeks of screening. Anatomical factors or other considerations such as claustrophobia that would make using the NHF equipment difficult or uncomfortable for the patient.; Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic treatment within 4 weeks prior to commencing study treatment. Patients with a history of non-compliance with treatment/management. Patients with significant medical conditions other than bronchiectasis: A significant disease is one that would, in the opinion of the investigator, put the participant at risk through participation in the study, or a disease that may influence the results of the study, or the participant’s ability to participate in the study. Patients with cystic fibrosis. Patients with primary ciliary dyskinesia. Patients with hypogammaglobulinaemia. Patients with allergic bronchopulmonary aspergillosis (total IgE greater than 420 IU/ml Aspergillus specific IgE level of 3+ or 4+, and proximal bronchiectasis on HRCT). Patients taking immunosuppressive agents (e.g., azathioprine, methotrexate, cyclophosphamide) or long term corticosteroid therapy. Patients with other primary or acquired immunodeficiency. Patients on long term oxygen therapy. Patients with evidence of active or suspected cancer and patients having undergone cancer treatment including resection, radiation therapy or chemotherapy within the last 2 years (patients with basal cell carcinoma and squamous cell carcinoma are allowed). Pregnant or lactating women. Participation in a separate clinical or device trial within 4 weeks of screening. Anatomical factors or other considerations such as claustrophobia that would make using the NHF equipment difficult or uncomfortable for the patient.

研究者

发起方
Fisher and Paykel Healthcare

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