Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001013853
Ethics application status
Approved
Date submitted
8/06/2021
Date registered
4/08/2021
Date last updated
4/08/2021
Date data sharing statement initially provided
4/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
N Acetylcysteine in Bronchiectasis.
Scientific title
N Acetylcysteine in Adults with Bronchiectasis: A feasibility pilot study assessing, anti-inflammatory and clinical effects.
Secondary ID [1] 304335 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
bronchiectasis 322093 0
Condition category
Condition code
Respiratory 319806 319806 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
N acetylcysteine capsules 600mg 2 tablets morning and night for 6 weeks
Intervention code [1] 320687 0
Treatment: Drugs
Comparator / control treatment
Placebo: 2 microcellulose capsules morning and night
Control group
Placebo

Outcomes
Primary outcome [1] 327675 0
sputum neutrophil elastase
Timepoint [1] 327675 0
Baseline, 3 and 6 weeks
Secondary outcome [1] 396200 0
lung function assessed by spirometry
Timepoint [1] 396200 0
Baseline and 6 weeks
Secondary outcome [2] 396622 0
quality of life as assessed by the Bronchiectasis Quality of Life Questionnaire
Timepoint [2] 396622 0
baseline and 6 weeks
Secondary outcome [3] 396628 0
Adverse effects assessed direct questioning from a checklist developed for this study.Possible side effects include dyspepsia, reflux abdominal discomfort,
Timepoint [3] 396628 0
baseline, 3 and 6 weeks
Secondary outcome [4] 397749 0
Sputum MUC5B
Timepoint [4] 397749 0
Baseline, 3 and 6 weeks
Secondary outcome [5] 397750 0
Sputum IL8
Timepoint [5] 397750 0
Baseline, 3 and 6 weeks
Secondary outcome [6] 397753 0
Dyspnoea assessed by the modified Medical Research Council scale
Timepoint [6] 397753 0
Baseline and 6 weeks

Eligibility
Key inclusion criteria
bronchiectasis
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current smokers, those with greater than 20 pack year history, cystic fibrosis, non tuberculous mycobacterial infection.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/09/2018
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
22/12/2021
Actual
Sample size
Target
30
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308708 0
Charities/Societies/Foundations
Name [1] 308708 0
Western Health Foundation Grant
Country [1] 308708 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Western Health Foundation
Address
Western Health Centre for Research and Education (WHCHRE), Furlong Road, St Albans VIC 3021
Country
Australia
Secondary sponsor category [1] 309597 0
None
Name [1] 309597 0
Address [1] 309597 0
Country [1] 309597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308632 0
St Vincent's Human Research Ethics Committee
Ethics committee address [1] 308632 0
St Vincent's Hospital
Royal Parade
Melbourne
Victoria
3065
Ethics committee country [1] 308632 0
Australia
Date submitted for ethics approval [1] 308632 0
Approval date [1] 308632 0
05/08/2018
Ethics approval number [1] 308632 0

Summary
Brief summary
This pilot study aims to examine the anti-inflammatory and clinical effects of oral N acetylcysteine( 2400 mg/day) in bronchiectasis over a 6 week period compared with placebo.We hypothesise it will improve these outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111374 0
A/Prof Lata Jayaram
Address 111374 0
Western Health
Gordon St
Footscray VIC
Locked Bag 2, Footscray VIC 3011
Country 111374 0
Australia
Phone 111374 0
+61 3 8395 8071
Fax 111374 0
Email 111374 0
[email protected]
Contact person for public queries
Name 111375 0
A/Prof Lata Jayaram
Address 111375 0
Western Health,
Gordon St
Footscray VIC
Locked Bag 2, Footscray VIC 3011
Country 111375 0
Australia
Phone 111375 0
+61 3 8395 8071
Fax 111375 0
Email 111375 0
[email protected]
Contact person for scientific queries
Name 111376 0
A/Prof Lata Jayaram
Address 111376 0
Western Health
Gordon St
Footscray VIC
Locked Bag 2, Footscray VIC 3011
Country 111376 0
Australia
Phone 111376 0
+61 3 8395 8071
Fax 111376 0
Email 111376 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?

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.