ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Bronchiectasis

Condition category

Condition code

Respiratory

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]

Not applicable

Comparator / control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Quality of Life Bronchiectasis - Respiratory Symptoms

Timepoint [1]

1, 3, and 12 months post-enrolment

Secondary outcome [1]

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]

12 months on study verse 12 months prior to study

Secondary outcome [2]

Self efficacy for managing Chronic Diseases 6 Questionnaire (SEMCD6)

Timepoint [2]

1, 3, and 12 months post-enrolment

Secondary outcome [3]

Forced Vital Capacity (FVC)

Timepoint [3]

1, 3, and 12 months post-enrolment

Secondary outcome [4]

Forced Expiratory Volume in 1 second

Timepoint [4]

1, 3, and 12 months post-enrolment

Secondary outcome [5]

Qualitative interviewing of by semi structured interviews with a non-clinical member of the study team reviewing the participant experience.

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Mitchell Talor

Address [1]

Functional Lungs
112B Railway St Corrimal, 2518, NSW

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Camperdown NSW 2006

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Air Liquide Healthcare

Address [1]

4.03/247 Coward St, Mascot NSW 2020

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District Ethics Committee

Ethics committee address [1]

Cnr Kingsway &, Kareena Rd, Caringbah NSW 2229

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/09/2022

Approval date [1]

13/09/2022

Ethics approval number [1]

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

Mr Mitchell Taylor

Address

Functional Lungs
112b railway St Corrimal, 2518, NSW, Australia

Country

Australia

Phone

+61474565442

Fax

[email protected]

Contact person for public queries

Name

Mitchell Taylor

Address

Functional Lungs
112b railway St Corrimal, 2518, NSW, Australia

Country

Australia

Phone

+61474565442

Fax

[email protected]

Contact person for scientific queries

Name

Mitchell Taylor

Address

Functional Lungs
112b railway St Corrimal, 2518, NSW, Australia

Country

Australia

Phone

+61474565442

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17312	Study protocol			[email protected]

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
Dimensions AI	Developments and priorities in bronchiectasis research	2023	https://doi.org/10.1016/s2213-2600(23)00258-8

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

Trial Review

Documents added manually

Documents added automatically