None listed
Conditions
Brief summary
Bronchiectasis is a chronic, debilitating disease characterised by productive cough, airway inflammation, and repeated respiratory infections. We currently have limited treatment options and the mainstay of treatment relies heavily on antibiotic therapy. This is a condition that is relatively common in our South Auckland population compared with equivalent populations in developed countries. It disproportionately affects our Maori and Pacific populations and any positive interventions developed for this condition would therefore lead to narrowing of equity gaps in clinical outcomes. Nasal high flow (NHF) is an integrated flow generator device that delivers warmed and humidified air to spontaneously breathing patients. It can be given in the home setting for several hours per day at the patient’s convenience. We hypothesise that NHF will help patients with bronchiectasis through its enhancement of clearance of mucus and positive effects on lung function and gas exchange. Being a non-pharmacological treatment it has the advantage of not having drug-related side effects. Potential benefits include reduced frequency of chest infections (exacerbations), improved quality of life, and reduced usage of healthcare resources and associated costs. The primary aim of this study is to assess feasibility of whether humidified air delivered in the home by NHF (2 to 4 hours usage per day) produces signals in terms of improved quality of life, symptom scores, sputum clearance, sputum inflammatory markers, and exacerbations. This study will be a randomised cross-over design, where half the patients have treatment for 3 months, half have usual care for 3 months, then they swap over for a further 3 months after a 4-week break. There will then be a 3-month period of follow up off treatment for all patients. In so doing our study will address feasibility issues to inform the development ultimately of a larger, randomised, placebo-controlled trial of this intervention.
Interventions
Nasal High flow (NHF) therapy will be used to deliver warm and humid air to spontaneously breathing participants during the night. The NHF is hypothesised to improve mucous clearance in participants with Bronchiectasis. The device will provide an airflow rate expected at 25-30L/min, with participant ability to reduce this to 20L/min, for a minimum of 4 hours. Temperature will be supplied at 37C, with variation between 31C to 37C The intervention will take place daily at home whilst the participa
Nasal High flow (NHF) therapy will be used to deliver warm and humid air to spontaneously breathing participants during the night. The NHF is hypothesised to improve mucous clearance in participants with Bronchiectasis. The device will provide an airflow rate expected at 25-30L/min, with participant ability to reduce this to 20L/min, for a minimum of 4 hours. Temperature will be supplied at 37C, with variation between 31C to 37C The intervention will take place daily at home whilst the participant is asleep over a 12 week period, and will crossover after a 4 week washout period. The device provides the room air, without oxygen supplementation, from the device through a heated breathing tube and nasal cannulae fitted to the participants head. Participants will recruited from community with a confirmed diagnosis of bronchiectasis. Participant adherence will be monitored as part of the device, and will be monitored by study staff. Participant behaviour of use, adherence and duration of use of the device will not be modified, as this is a secondary endpoint. Standard of care will be provided to all participants on each arm, where standard of care will be managed and defined by best practice provided through their respiratory physician, and will not be influenced by this study.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed