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Trial registered on ANZCTR


Registration number
ACTRN12625000660482p
Ethics application status
Submitted, not yet approved
Date submitted
4/06/2025
Date registered
23/06/2025
Date last updated
23/06/2025
Date data sharing statement initially provided
23/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Airway Clearance Techniques in children with chronic suppurative lung diseases: a randomised controlled trial
Scientific title
The Efficacy of Airway Clearance Techniques on cough resolution in children with chronic suppurative lung diseases: a randomised controlled trial
Secondary ID [1] 314598 0
Nil known
Universal Trial Number (UTN)
Trial acronym
E-ACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic suppurative lung disease 337722 0
Protracted bacterial bronchitis 337721 0
Condition category
Condition code
Infection 334147 334147 0 0
Other infectious diseases
Respiratory 334051 334051 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of an airway clearance program prescribed by a physiotherapist with clinical experience in chronic respiratory disease management in children at the study site.

Prescription of one or a combination of the following airway clearance programs, depending on age and ability of patient and carer. For children aged >2years, TherabubbleTM or Hydrapep (PEP) will be trialled at the initial consultation with the physiotherapist. In general, once the child is old enough to be able to coordinate undertaking PEP, this program will be prescribed preferentially over manual techniques. Where the child is unable to coordinate the PEP therapy (i.e., usually <2-years), manual techniques and/or active breathing techniques will be undertaken. The duration is 10-15minutes, twice a day, until 1-week post cough resolution.
1. TherabubbleTM or Hydrapep are TGA approved devices. Both devices are a form of positive expiratory pressure airway clearance. The duration is 10-15minutes, twice a day, until 1-week post cough resolution. The 10-15minute program includes sets of breaths for approximately 3-4 seconds exhalation. The physiotherapist may suggest sets of 5-10 sets of 10-15 breaths followed by huff and cough or time the sets for 3-5minutes each, depending on suitability with the patient again with each set being followed with huff and cough.
2. Manual techniques: Percussion is performed by the carer who has received instructions on the technique. The carer is taught how to undertake percussion in six possible positions. The carer is taught to undertake 10-15min twice a day. A huff (if able) and cough are encouraged at least three times during each session, if the child is old enough to understand.
3. Modified active breathing techniques: Deep breathing with active play using whistles, bubbles and balloons. The carer will be taught how to integrate active play with deep breathing with the use of bubbles, whistles and balloons for 10-15minutes twice daily. A huff (if able) and cough is encouraged at least three times during each session, if the child is old enough to understand.

Note: Both Therabubble and Hydrapep are positive expiratory pressure therapies in the form of a plastic, multi-use (but for same patient only) bottle device. The bottle has a sealed lid, with a tubing (10mm diameter), which sits at the bottom of the bottle and then above the sealed lid so that the patient can blow into the tubing. The resistance with the apparatus is created by a water seal. The patient sits at a table and the bottle is filled to the correct level. The patient holds the tubing with one hand and then puts the end of the tubing in their mouth, seals the lips around the tubing and takes a slightly larger than tidal volume breath and breaths out for the 3-4 seconds. The patient is essentially blowing out against the resistance of the water, and this creates a "back pressure" or positive pressure which moves the secretions to where the patient can cough them up.

All airway clearance programs will be taught in an outpatient clinic setting at either a hospital or private respiratory clinic. The duration of the teaching session will be a single session of 45minutes to 1-hour duration. Airway clearance will then be performed by the parent/carer independently at home each day for the duration specified by the physiotherapist.
Strategies to assess adherence are a daily diary where the parent reports if airway clearance was performed and for how long.
Intervention code [1] 331221 0
Treatment: Other
Intervention code [2] 331272 0
Treatment: Devices
Comparator / control treatment
Standard care - oral antibiotic therapy for prescribed duration - expected to be two-six weeks depending on patient requirement.
Control group
Active

Outcomes
Primary outcome [1] 341713 0
The primary outcome will be the proportion of children with cough resolution by day-10
Timepoint [1] 341713 0
Day 10 post intervention commencement
Secondary outcome [1] 448478 0
1. The time to next exacerbation
Timepoint [1] 448478 0
Once monthly, for up to 12-months from enrolment
Secondary outcome [2] 448479 0
Change in Cough-related Quality of Life (PC-QoL)11 from day 1 to day 10 and 28
Timepoint [2] 448479 0
survey undertaken at enrolment and then day 10 and day 28 following enrolment
Secondary outcome [3] 448480 0
Days to cough clearance
Timepoint [3] 448480 0
Daily (via online cough diary) and telephone review at day-10 and day-28 following enrolment

Eligibility
Key inclusion criteria
Meeting the diagnostic criteria for suspected or confirmed protracted bacterial bronchitis (PBB) or chronic suppurative lung disease (CSLD)
Aged between 0-16 years age
Receiving routine standard treatment with oral antibiotic therapy
Voluntarily agreeing to participate
Ability to understand English
Note: Children with mild hypotonia, mild developmental delay and mild aspiration are not excluded in the study and airway clearance technique will be prescribed to mitigate aspiration risk e.g., airway clearance performed prior to feeding.
CT or chest cray changes as follows are included: peribronchial wall thickening and gas trapping/mucus plugging, tracheo-bronchomalacia, subpleural bleb and atelectasis
Minimum age
1 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of other chronic respiratory illness (other than asthma) such as bronchiectasis, primary ciliary dyskinesia, cystic fibrosis
Children with neurological Gross Motor Function classification of V or other severe neuromuscular disability affecting the child’s ability to follow instructions related to breathing and coughing to command
Contraindications for airway clearance such as recent haemoptysis, recent facial surgery, current rib fracture, recent open-heart surgery
Chest Xray or CT abnormality other than peribronchial wall thickening and gas trapping/mucus plugging, tracheo-bronchomalacia, subpleural bleb and atelectasis

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)
Computer generated using the Sealed Envelope platform (www.sealedenvelope.com),
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer-generated randomisation will be stratified by age (6years) using permuted blocks (randomly alternating between block sizes of 4 and 6). (The 1:1 allocation sequence will be prepared by an independent statistician, using the Sealed Envelope platform (www.sealedenvelope.com), and will be preloaded into the studies REDCap database. This means participants assigned group will be revealed by REDCap following consent.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be exported from REDCap and processed into the form of one record per participant. Basic descriptive statistics will be used to describe and characterise the data, including reporting means and standard deviations, medians and interquartile ranges, and counts and percentages, as appropriate.
The secondary variable will be the proportion of children with cough resolution at day 10. The primary reported analysis will be a two-sided difference in proportions between groups. Alongside this, a sensitivity analysis will be carried out using logistic regression, where covariate adjustments will be made for the stratification variable (age > or < 6 years) and other potential confounders or variables showing baseline imbalance, which may include sex, ethnicity, clinical history of respiratory complications, presence of airway malacia. Here, we will report the adjusted odds ratio (with 95% confidence interval) for cough resolution in the treatment group relative to the control group.
Secondary outcome measures:
1. The time to next exacerbation will likely be evaluated using linear regression. Here, we will report the adjusted difference in means (with 95% confidence interval) between groups. The covariate adjustments listed for the primary outcome may also be incorporated into this analysis.
2. The difference in PC-QoL scores for children from day-1 to day-10 and day-1 to day-28 will be summarised by their mean and standard error. The difference in PC-QoL scores between the treatment and control groups, at day-10 and day-28 separately, will be compared using an ANCOVA framework. That is, the day-10 and day-28 scores (separately) will be the outcome variable, with the day-1 scores will be included as an adjustment variable. The minimum important difference in scores is 0.918, with the higher score representing a better cough-related quality of life. Here, we will report the adjusted mean difference (with 95% confidence interval) in PC-QoL between groups. The covariate adjustments listed for the primary outcome may also be incorporated into this analysis.
3. The time to next exacerbation will be evaluated will likely be analysis using Tobit regression, as it is expected this will be a censored outcome with some patients not experiencing an exacerbation. Here, we will report the coefficient for the group variable (with 95% confidence interval), which is used to understand the direction, magnitude, and significance of the difference between groups while accounting for the censored nature of the data. The covariate adjustments listed for the primary outcome may also be incorporated into this analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 28008 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 44211 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 319155 0
Government body
Name [1] 319155 0
Western Australian Department of Health
Country [1] 319155 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The. Kids Research Institute Australia
Address
Country
Australia
Secondary sponsor category [1] 321613 0
Government body
Name [1] 321613 0
The Child and Adolescent Health Service (Western Australia)
Address [1] 321613 0
Country [1] 321613 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317737 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 317737 0
Ethics committee country [1] 317737 0
Australia
Date submitted for ethics approval [1] 317737 0
04/06/2025
Approval date [1] 317737 0
Ethics approval number [1] 317737 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141986 0
Dr Pamela Laird
Address 141986 0
The Kids Research Instutute Australia, 15 Hospital Ave Nedlands Western Australia 6009
Country 141986 0
Australia
Phone 141986 0
+61 410314437
Fax 141986 0
Email 141986 0
Contact person for public queries
Name 141987 0
Pamela Laird
Address 141987 0
The Kids Research Instutute Australia, 15 Hospital Ave Nedlands, Western Australia 6009
Country 141987 0
Australia
Phone 141987 0
+61 410314437
Fax 141987 0
Email 141987 0
Contact person for scientific queries
Name 141988 0
Pamela Laird
Address 141988 0
The Kids Research Instutute Australia, 15 Hospital Ave Nedlands, Western Australia 6009
Country 141988 0
Australia
Phone 141988 0
+61 410314437
Fax 141988 0
Email 141988 0

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not allowed under local ethics rules.



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.