RecruitingACTRN12626000558325

Investigating the use of humidified high flow therapy (supplemental oxygen optional) in the home setting for patients with existing lung disease (Chronic Obstructive Pulmonary Disease (COPD) or Bronchiectasis). The DOMINO Study

Efficacy of Domiciliary Humidified High Flow Nasal Therapy with or without supplemental oxygen in patients with bronchiectasis/COPD. The DOMINO study

Sponsor

Metro North Hospital and Health Services

Enrollment

60 participants

Start Date

Aug 16, 2025

Study Type

Interventional

Conditions

Chronic Obstructive Pulmonary Disease (COPD)Bronchiectasis

Summary

This randomised controlled feasibility trial will evaluate domiciliary Humidified High Flow Therapy (HHFT) in patients with COPD/Bronchiectasis. The primary aim is to determine the feasibility of a larger adequately powered trial and explore potential effects on exacerbation frequency, patient comfort, quality of life, and hospital admissions. Sixty participants will be recruited from respiratory inpatients/outpatients across two sites and randomised (1:1) to HHFT plus standard care or standard care alone. Intervention participants will use HHFT overnight where possible, or for a minimum of four hours per twenty-four hour period. Participants, once recruited will be discharged home or transferred to Hospital in the Home (HiTH) and will be followed at weeks 1-3 by telephone, week 4 face-to-face and month 2and 3 (study completion) by telephone. Adverse events and device performance will be monitored throughout the study period.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

years of age or above
Primary diagnosis of COPD or Bronchiectasis
Acute care in the home with HHFT and Optiflow Duet canulaTM is deemed beneficial by treating physician
Clinically suitable for discharge home or Hospital in the Home (HiTH) with HHFT therapy. This includes but not limited to having a safe home environment, fulfilling HiTH referral criteria.
Able to consent and comply to research study requirement including review appointments (phone and telehealth) and home visits.

Exclusion Criteria10

Diagnosed Cystic Fibrosis
Any patient being palliated on the end-of-life pathway
Currently treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV)
Receiving long term oxygen therapy of more than 4Litres/minute of supplementary oxygen
Has acute hypercapnic respiratory failure (pH45mmHg)
Currently participating in an investigational drug or device study
The participant has a medical condition that in the opinion of the investigator would exclude participation in the study.
Any physical limitation which would prevent the safe set up of the device.
Any cognitive impairment that would deem the use of a heated water chamber unsafe.
Unable to give informed consent.

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Interventions

Intervention Arm Intervention: Humidified High Flow Therapy (HHFT) Participants randomised to the intervention group will receive domiciliary humidified high flow therapy (HHFT) delivered via

Intervention Arm Intervention: Humidified High Flow Therapy (HHFT) Participants randomised to the intervention group will receive domiciliary humidified high flow therapy (HHFT) delivered via a myAirvo3™ device (Fisher & Paykel Healthcare) or equivalent system. The intervention will be administered in addition to usual care. HHFT will be delivered with the following parameters: Target flow rate of 40 L/min, titrated according to participant comfort and tolerance within a range of 20–40 L/min. Target temperature of 37°C, titrated according to participant comfort and tolerance. Fraction of inspired oxygen (FiO2) prescribed to achieve clinician-determined target oxygen saturation levels. Supplemental oxygen may be administered via an oxygen cylinder or home oxygen concentrator using standard low-flow delivery, titrated to clinician-determined target oxygen saturation levels in accordance with usual care. Use of supplemental oxygen is determined by the treating medical officer as part of routine clinical assessment; it is not protocol-mandated and is provided only when clinically indicated. While HHFT is in operation, it will replace existing long term oxygen therapy (LTOT). Participants will be instructed to use the device daily for a minimum of four hours per 24-hour period, preferably during sleep or periods of rest. The study period is 3 months. Adherence will be monitored via device-recorded usage data downloaded from the digital interface. Data will be recorded against study identification numbers to maintain confidentiality. The intervention will be initiated, monitored and reviewed by an experienced multidisciplinary clinical team in accordance with standard clinical practice. The research is overseen by experienced and published researchers through the Queensland University of Technology. Each participant will be enrolled in the study for 3 months. Baseline data is collected and timepoints of week 1,2,3 by telephone; week 4 face to face; Month 2 by telephone and final collection and completion of the study at 3 months.