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Modified forced expiration technique using expiratory resistance in adults with cystic fibrosis: A pilot study.

Measuring the impact of a modified forced expiration technique using expiratory resistance on ease of expectoration, sputum wet weight and cough frequency in adults with cystic fibrosis.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000224123
Acronym
MFET-CF
Enrollment
14
Registered
2019-02-15
Start date
2019-10-01
Completion date
2024-12-11
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The development of an effective airway clearance regimen is important to minimise development of irreversible airway obstruction in people with cystic fibrosis. Positive expiratory pressure (PEP) is often used as it helps to provide resistance during expiration, improve collateral ventilation and aid in the shearing of mucus from airways. The use of PEP and other expiratory resistive devices (ERD) as airway clearance techniques (ACT) in this population is well established in the literature but there is no literature which looks at the use of an ERD combined with masks during huffing, to improve sputum clearance. The proposed study will investigate the effect of using an ERD during a huff on ease of expectoration, sputum volume, and coughing, when compared to a huff without resistance. The hypothesis is that using an ERD during a huff will improve ease of expectoration, sputum volume and reduce amount of coughing required.

Interventions

The design of this trial will be a randomised crossover trial. The study will consist of a morning and afternoon treatment (single day) consisting of 10 cycles of the participant’s usual airway clearance techniques (ACT). Each session will last approximately 30 minutes and the washout period will be at least 2 hours between sessions. Half (5) of the forced expiratory technique (FET) components will be performed with an expiratory resistance device (ERD), the other half will consist of the FET al

The design of this trial will be a randomised crossover trial. The study will consist of a morning and afternoon treatment (single day) consisting of 10 cycles of the participant’s usual airway clearance techniques (ACT). Each session will last approximately 30 minutes and the washout period will be at least 2 hours between sessions. Half (5) of the forced expiratory technique (FET) components will be performed with an expiratory resistance device (ERD), the other half will consist of the FET alone. The two FET methods will be alternated throughout each cycle in the session. There is no time period between airway clearance cycles, the patient will continue onto the next cycle as soon as they have caught their breath following the FET and cough. The expiratory resistance device will consist of a mask which provides positive expiratory pressure which aims to increase airway stability during a forced expiratory technique. The forced expiratory technique (otherwise termed a huff) is a form of airway clearance similar to a cough but requires less force, is less fatiguing and targets secretions from distal airways. Participants will be randomly allocated to perform the FET with the ERD or without the ERD and will alternate from the variable starting points. This will be repeated in the afternoon session, however the first cycle will start with the opposite FET method to the morning session. Ease of expectoration during the FET will be measured using a Visual Analogue Scale (VAS) following each cycle. The number of coughs will also be measured following each cycle. Sputum wet weight for each FET method and patient preference will be documented at the end of each session. Adherence to the intervention will be monitored by direct observation by study personnel.

Sponsors

Sir Charles Gairdner Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

People with CF who: (i) are aged 18 years and; (ii) are admitted to the Respiratory Medicine ward at SCGH for an acute exacerbation of CF.

Exclusion criteria

(i) the inability to provide written informed consent; (ii) haemoptysis; (iii) use of non-invasive ventilation; (iv) pneumothorax and; (v) inability to expectorate sputum.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026