ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000224123

Ethics application status

Approved

Date submitted

11/02/2019

Date registered

15/02/2019

Date last updated

15/10/2021

Date data sharing statement initially provided

15/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

MFET-CF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cystic Fibrosis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Human Genetics and Inherited Disorders

Cystic fibrosis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Randomised cross-over study with participants acting as their own control

Control group

Active

Outcomes

Primary outcome [1]

Ease of expectoration - measured using a 10 cm VAS.

Timepoint [1]

Measured after every ACT cycle

Secondary outcome [1]

Sputum wet weight - measured on an Adam Equipment Nimbus Precision NBL 423e calibrated to 0.001g.

Timepoint [1]

Measured after each ACT session.

Secondary outcome [2]

Number of coughs in each cycle throughout session - will be manually counted by the treating therapist.

Timepoint [2]

Counted during each cycle.

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

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)

A computer generated randomisation sequence with the group allocation placed in opaque envelopes will be used to provide allocation concealment. The envelope will be selected by a member of the research team who will not be involved with the treatment session or data collection. This will minimise the risk of selection bias.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data will be analysed using SPSS (Version 22, SPSS, Chicago, IL, USA). The distribution of data will be checked for normality using frequency histograms and Shapiro-Willk test. A p value of < 0.05 will be considered statistically significant. The data will be analysed with an independent samples t-test or Mann-Whitney U test.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/04/2019

Actual

1/10/2019

Date of last participant enrolment

Anticipated

29/10/2021

Actual

Date of last data collection

Anticipated

12/11/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue, Nedlands, Perth, Western Australia 6009

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

2 Hospital Avenue, Nedlands, Perth, WA. 6009.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Department of Health WA Human Research Ethics Committee [EC00422]

Ethics committee address [1]

PO Box 8172
Perth Business Centre
Perth WA 6849

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/02/2019

Approval date [1]

09/09/2019

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Kathryn Watson

Address

Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
Perth WA
6009

Country

Australia

Phone

+61 8 64572337

Fax

kathryn.watson@health.wa.gov.au

Contact person for public queries

Name

Kathryn Watson

Address

Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
Perth WA
6009

Country

Australia

Phone

+61 8 64572337

Fax

kathryn.watson@health.wa.gov.au

Contact person for scientific queries

Name

Kathryn Watson

Address

Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
Perth WA
6009

Country

Australia

Phone

+61 8 64572337

Fax

kathryn.watson@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Modified forced expiration technique using expiratory resistance in adults with cystic fibrosis.	2023	https://dx.doi.org/10.1111/crj.13708

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically