Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001338752
Ethics application status
Approved
Date submitted
10/10/2022
Date registered
18/10/2022
Date last updated
18/10/2022
Date data sharing statement initially provided
18/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of airway clearance in bronchiectasis: A prospective cohort study and review of the patient experience
Scientific title
The effectiveness of airway clearance in bronchiectasis: A prospective cohort study and review of the patient experience
Secondary ID [1] 308146 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 327865 0
Condition category
Condition code
Respiratory 324947 324947 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The effect of usual care will be studied in patients receiving respiratory physiotherapy for the treatment of bronchiectasis.

Participants will be monitored at month 1, 3 and 12 with a review of quality of life, spirometry, exacerbation frequency and self efficacy.

Usual care consists of a a diverse range of physiotherapy treatments (such as education, positive expiratory pressure therapy, oscillating positive expiratory Pressure therapy, gravity assisted drainage and nebulised saline adjuncts) used to optimise airway clearance in bronchiectasis patients that will be administered in an as needed basis, titrating therapies to individual needs.

Participants who choose not to enroll or are ineligible for the study will continue to receive usual care treatment at the practice (same therapy as the study protocol)

Completion of the questionnaires will take approximately 15 minutes per session. A baseline spirometry will usually take an addition 15 minutes to complete.

All assessments (spirometry inclusive) will be performed by the treating physiotherapist. A spirometry assessment involves a maximal inhale, followed by a maximal forced exhale into a calibrated device which measures the volume and flow of air expired.

Intervention code [1] 324601 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332757 0
Quality of Life Bronchiectasis - Respiratory Symptoms
Timepoint [1] 332757 0
1, 3, and 12 months post-enrolment
Secondary outcome [1] 414633 0
Pulmonary Exacerbation Frequency during study compared with 12 months prior to the study. Pulmonary exacerbation criteria is the prescription of antibiotics by a treating physician for a respiratory exacerbation. Medical records will be reviewed and scripts cited to confirm pulmonary exacerbations.
Timepoint [1] 414633 0
12 months on study verse 12 months prior to study
Secondary outcome [2] 414634 0
Self efficacy for managing Chronic Diseases 6 Questionnaire (SEMCD6)
Timepoint [2] 414634 0
1, 3, and 12 months post-enrolment
Secondary outcome [3] 414635 0
Forced Vital Capacity (FVC)
Timepoint [3] 414635 0
1, 3, and 12 months post-enrolment
Secondary outcome [4] 414761 0
Forced Expiratory Volume in 1 second
Timepoint [4] 414761 0
1, 3, and 12 months post-enrolment
Secondary outcome [5] 414762 0
Qualitative interviewing of by semi structured interviews with a non-clinical member of the study team reviewing the participant experience.
Timepoint [5] 414762 0
Between 12-14 months post enrollment

Eligibility
Key inclusion criteria
1) Provide their informed consent to participate.
2) Male or Female above 18 years of age (inclusive) at screening.
3) Bronchiectasis diagnosed by a treating physician.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current smokers as defined by the Centre of Disease C ontrol.
2) Inability to follow the procedures of the study (e.g. due to barriers of language or cognition)
3) Cardiothoracic surgery within 6 weeks prior to enrolment
4) Subjects who have had adjustments to their baseline medications within 1 month prior to screening
5) Subjects who started on macrolides within 12 months of enrolment.
6) Subjects taking antibiotics for an acute exacerbation at the time of enrolment.
7) Severe concomitant illness that may prevent optimal participation in the study
8) A direct relative of the investigation team
9) Women who are pregnant
10) Participation in another clinical trial for bronchiectasis

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All analyses will be performed using SPSS (Version 22 for Windows, IBM, USA). Intention-to-treat analysis will be conducted, and a p-value of < 0.05 considered significant. Within-group comparisons will be examined using paired t-tests and described as mean differences with 95% CIs.

A total of 86 participants will be required to detect a difference in QOL-B over 12 months (a = 0.05, 80% power). These sample size calculations are based a MCID of 8 points, a standard deviation of 17.4points and a drop out of 15%.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/11/2022
Actual
Date of last participant enrolment
Anticipated
6/03/2024
Actual
Date of last data collection
Anticipated
6/03/2025
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312411 0
Self funded/Unfunded
Name [1] 312411 0
Mitchell Talor
Country [1] 312411 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 313981 0
Commercial sector/Industry
Name [1] 313981 0
Air Liquide Healthcare
Address [1] 313981 0
4.03/247 Coward St, Mascot NSW 2020
Country [1] 313981 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311758 0
South Eastern Sydney Local Health District Ethics Committee
Ethics committee address [1] 311758 0
Cnr Kingsway &, Kareena Rd, Caringbah NSW 2229
Ethics committee country [1] 311758 0
Australia
Date submitted for ethics approval [1] 311758 0
02/09/2022
Approval date [1] 311758 0
13/09/2022
Ethics approval number [1] 311758 0
2022/ETH01646

Summary
Brief summary
The primary aim of this study is to evaluate the effect of a titrated respiratory physiotherapy treatment protocol on subject quality of life over a 12-month period. Secondary outcomes include rate of lung infections (pulmonary exacerbations), spirometry, patient self-efficacy and the patient experience assessed through qualitative interviewing. Enrolled study participants will be provided a tailored airway clearance program by a trained respiratory physiotherapist to augment clearance of excess secretions from the lungs. The efficacy of this program will be reviewed at regular intervals during the treatment period. If required the subject’s airway clearance regime will be up-titrated to improve effectiveness of the treatment. We hypothesise that this outcome-based customization of airway clearance will improve quality of life, spirometry and self-efficacy in patients with bronchiectasis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122262 0
Mr Mitchell Taylor
Address 122262 0
Functional Lungs
112b railway St Corrimal, 2518, NSW, Australia
Country 122262 0
Australia
Phone 122262 0
+61474565442
Fax 122262 0
Email 122262 0
[email protected]
Contact person for public queries
Name 122263 0
Mitchell Taylor
Address 122263 0
Functional Lungs
112b railway St Corrimal, 2518, NSW, Australia
Country 122263 0
Australia
Phone 122263 0
+61474565442
Fax 122263 0
Email 122263 0
[email protected]
Contact person for scientific queries
Name 122264 0
Mitchell Taylor
Address 122264 0
Functional Lungs
112b railway St Corrimal, 2518, NSW, Australia
Country 122264 0
Australia
Phone 122264 0
+61474565442
Fax 122264 0
Email 122264 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17312Study protocol  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIDevelopments and priorities in bronchiectasis research2023https://doi.org/10.1016/s2213-2600(23)00258-8
N.B. These documents automatically identified may not have been verified by the study sponsor.