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Trial registered on ANZCTR


Registration number
ACTRN12621001122842
Ethics application status
Approved
Date submitted
18/06/2021
Date registered
23/08/2021
Date last updated
5/07/2024
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nasal high flow therapy in bronchiectasis
Scientific title
Effect of domiciliary humidified nasal high flow air on airway inflammation markers in bronchiectasis: a randomised, cross-over study.
Secondary ID [1] 304122 0
Nil known
Universal Trial Number (UTN)
U1111-1249-2221
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 321808 0
Condition category
Condition code
Respiratory 319534 319534 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320456 0
Treatment: Devices
Comparator / control treatment
Participants will be recruited and will be provided standard of care and management for bronchiectasis for 12 weeks, and will crossover after a 4 week washout period. Standard of care at home may include inhalers, long-term antibiotics, and self-administered physiotherapy manoeuvres. This will be under the instruction of their treating physician guided by international evidence-based standards and their respective experience, as well as patient preference.
Control group
Active

Outcomes
Primary outcome [1] 327494 0
Sputum neutrophil elastase level
Timepoint [1] 327494 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week, primary endpoint), End Period 2 visit (28 week).
Secondary outcome [1] 395367 0
Nasal high flow device tolerability, through participant reporting and device use recording.
Timepoint [1] 395367 0
Daily monitoring for the duration of the 12-week intervention
Secondary outcome [2] 395368 0
Airway inflammation marker - Sputum high sensitivity CRP (hs-CRP)
Timepoint [2] 395368 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [3] 395369 0
Concentration of sputum procalcitonin
Timepoint [3] 395369 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [4] 395371 0
Quality of life assessed by Health-related quality of life (HR-QoL)
Timepoint [4] 395371 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [5] 395372 0
St Georges Respiratory Questionnaire (SGRQ)
Timepoint [5] 395372 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [6] 395373 0
Bronchiectasis Health Questionnaire (BHQ)
Timepoint [6] 395373 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [7] 395374 0
The Leicester Cough Questionnaire (LCQ)
Timepoint [7] 395374 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [8] 395375 0
SNOT-22 Questionnaire (upper airway symptoms)
Timepoint [8] 395375 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [9] 395376 0
Pulmonary exacerbations will be assessed from antibiotic use, assessed using participant self-reporting, and community reports from community healthcare providers.
Timepoint [9] 395376 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week), as indicated
Secondary outcome [10] 395377 0
Modified MRC score assessing degree of dyspnoea
Timepoint [10] 395377 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [11] 395378 0
Lung function (spirometry: FEV1, FVC)
Timepoint [11] 395378 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week)
Secondary outcome [12] 398339 0
Nasal high flow device safety
Timepoint [12] 398339 0
Daily monitoring for the duration of the 12-week intervention, collected at the final visit for the intervention arm. where any associated adverse events will be defined by CTCAE v5.0 guidelines.
Secondary outcome [13] 398340 0
Nasal high flow device adherence, measured through device recording use.
Timepoint [13] 398340 0
Daily monitoring for the duration of the 12-week intervention, as indicated
Secondary outcome [14] 398341 0
Pulmonary exacerbations will be assessed by frequency, provided through participant self-reporting
Timepoint [14] 398341 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week), as indicated
Secondary outcome [15] 398342 0
Pulmonary exacerbations will be assessed from time to first exacerbation, provided by participant self-reporting, and community healthcare provider reports.
Timepoint [15] 398342 0
Baseline Period 1 (0 week), End Period 1 visit (12 weeks), Baseline Period 2 (16 week), End Period 2 visit (28 week), as indicated

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of treatment will be performed using a block randomisation algorithm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
6/07/2021
Date of last participant enrolment
Anticipated
31/03/2024
Actual
30/11/2022
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
40
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 23702 0
New Zealand
State/province [1] 23702 0
Auckland

Funding & Sponsors
Funding source category [1] 308500 0
Government body
Name [1] 308500 0
Ko Awatea
Country [1] 308500 0
New Zealand
Funding source category [2] 308886 0
Charities/Societies/Foundations
Name [2] 308886 0
Maurice and Phyllis Paykel Trust
Country [2] 308886 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 309808 0
None
Name [1] 309808 0
Address [1] 309808 0
Country [1] 309808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308461 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 308461 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 308461 0
New Zealand
Date submitted for ethics approval [1] 308461 0
04/06/2020
Approval date [1] 308461 0
09/09/2020
Ethics approval number [1] 308461 0
20NTA93

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110766 0
Dr Paul Dawkins
Address 110766 0
New Zealand Respiratory Institute (NZRSI)
Ascot Office Park 93-95 Ascot Avenue
Greenlane East
Auckland 1051
Country 110766 0
New Zealand
Phone 110766 0
+6421557712
Fax 110766 0
Email 110766 0
Paul.Dawkins@middlemore.co.nz
Contact person for public queries
Name 110767 0
Ardra Chandran
Address 110767 0
New Zealand Respiratory Institute (NZRSI)
Ascot Office Park 93-95 Ascot Avenue
Greenlane East
Auckland 1051
Country 110767 0
New Zealand
Phone 110767 0
+64 9 638 5255
Fax 110767 0
Email 110767 0
ardra@nzrsi.health.nz
Contact person for scientific queries
Name 110768 0
Paul Dawkins
Address 110768 0
New Zealand Respiratory Institute (NZRSI)
Ascot Office Park 93-95 Ascot Avenue
Greenlane East
Auckland 1051
Country 110768 0
New Zealand
Phone 110768 0
+64 9 276 0000
Fax 110768 0
Email 110768 0
Paul.Dawkins@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.