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Trial registered on ANZCTR


Registration number
ACTRN12611001199909
Ethics application status
Approved
Date submitted
19/11/2011
Date registered
22/11/2011
Date last updated
13/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel interventions for the diverse population of Australians with bronchiectasis
Scientific title
The effect of azithromycin and hypertonic saline on quality of life, lung function and exercise capacity in adults with non-cystic fibrosis bronchiectasis
Secondary ID [1] 273428 0
None
Universal Trial Number (UTN)
Trial acronym
B2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-cystic fibrosis bronchiectasis 279074 0
Condition category
Condition code
Respiratory 279263 279263 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six month treatment of daily 250mg oral azithromycin; six month treatment of twice daily 4mL
nebulised 7% saline (with 0.25mg/mL quinine sulphate)

NOTE
This is a two-way factorial study (i.e. four groups in total:
1. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate);
2. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate);
3. Six month treatment with daily 40mg lactose and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate);
4. Six month treatment with daily 40mg lactose and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate),
with participants being allocated to one group for the entire 6-month intervention period.
Intervention code [1] 283649 0
Treatment: Drugs
Comparator / control treatment
Six month treatment of daily 40mg lactose (placebo); six month treatment of twice daily 4mL nebulised 0.9% saline (with 0.25mg/mL quinine sulphate) (placebo)

NOTE
This is a two-way factorial study (i.e. four groups in total:
1. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate);
2. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate);
3. Six month treatment with daily 40mg lactose and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate);
4. Six month treatment with daily 40mg lactose and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate),
with participants being allocated to one group for the entire 6-month intervention period.
Control group
Placebo

Outcomes
Primary outcome [1] 279884 0
Quality of life, measured with the St George Respiratory Questionnaire
Timepoint [1] 279884 0
Baseline (Month 0)
Month 1
Month 3
Month 6
Month 7 (one month after ceasing trial medications)
Secondary outcome [1] 294674 0
Quality of life, measured with the Quality of Life in Bronchiectasis Questionnaire (QoL-B)
Timepoint [1] 294674 0
Baseline (Month 0)
Month 1
Month 3
Month 6
Month 7 (one month after ceasing trial medications)
Secondary outcome [2] 294675 0
Lung function, measured with spirometry (FEV1, FVC, FEF25-75)
Timepoint [2] 294675 0
Baseline (Month 0)
Month 1
Month 3
Month 6
Month 7 (one month after ceasing trial medications)
Secondary outcome [3] 294676 0
Dyspnoea, measured with the Modified Medical Research Council Dyspnoea Scale
Timepoint [3] 294676 0
Baseline (Month 0)
Month 1
Month 3
Month 6
Month 7 (one month after ceasing trial medications)
Secondary outcome [4] 294677 0
Sputum microbiology, measured by quantitative bacterial load and the presence/absence of bacterial pathogens
Timepoint [4] 294677 0
Baseline (Month 0)
Month 6
Secondary outcome [5] 294678 0
Exercise tolerance, measured as distance covered on the modified shuttle test-25 (MST-25)
Timepoint [5] 294678 0
Baseline (Month 0)
Month 6
Secondary outcome [6] 294679 0
Adverse events, defined as any deterioration in clinical condition as noted by participants on a diary card.
Timepoint [6] 294679 0
Weekly, from baseline (Month 0) to trial completion (Month 7)
Secondary outcome [7] 294680 0
Respiratory exacerbations, defined as deterioration in at least 3 of these symptoms: cough, haemoptysis, dyspnoea, sputum purulence or volume, and chest pain
Timepoint [7] 294680 0
Weekly, from baseline (Month 0) to trial completion (Month 7)
Secondary outcome [8] 294681 0
Medication usage, as recorded by participants on a diary card.
Timepoint [8] 294681 0
Weekly, from baseline (Month 0) to trial completion (Month 7)
Secondary outcome [9] 294682 0
Tolerability of trial nebulised saline, measured on visual analogue scales and a record of the number of doses reported to be missed due to poor tolerability
Timepoint [9] 294682 0
Baseline (Month 0)
Month 1
Month 3
Month 6

Eligibility
Key inclusion criteria
Non-cystic fibrosis bronchiectasis (defined as chronic cough and sputum production with at least two lobes involved on HRCT);
Aged at least 18 years;
FEV1 within 10% of the best outpatient value during the previous six months;
At least two weeks since antibiotics for a respiratory exacerbation
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent;
Known allergy to macrolide therapy or quinine sulphate;
Thrombocytopaenia;
Immune thrombocytopaenia purpura (ITP);
Hypertonic saline or mannitol therapy in the previous two weeks;
Macrolide therapy in the previous four weeks;
Use of drugs contra-indicated by macrolide therapy;
FEV1<30% predicted;
Current smoking;
Unstable coronary heart disease;
Carcinoma;
Immunodeficiency;
Renal failure;
Severe liver disease;
Cerebrovascular disease;
Previous organ transplant;
Current or intended pregnancy in the following seven months;
Participation in another clinical trial in the previous 30 days or intended in the following seven months;
Non-tuberculous mycobacterium identified in sputum culture

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Two-way factorial study (i.e. four groups in total:
1. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate);
2. Six month treatment with daily 250mg oral azithromycin and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate);
3. Six month treatment with daily 40mg lactose and twice daily nebulised 7% saline (with 0.25mg/mL quinine sulphate);
4. Six month treatment with daily 40mg lactose and twice daily nebulised 0.9% saline (with 0.25mg/mL quinine sulphate);
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)
Recruitment postcode(s) [1] 4669 0
2050
Recruitment postcode(s) [2] 4670 0
2170
Recruitment postcode(s) [3] 4671 0
2305
Recruitment postcode(s) [4] 4672 0
2016
Recruitment postcode(s) [5] 4673 0
4032
Recruitment postcode(s) [6] 4674 0
4101
Recruitment postcode(s) [7] 4675 0
4120
Recruitment postcode(s) [8] 4676 0
4870

Funding & Sponsors
Funding source category [1] 284131 0
Government body
Name [1] 284131 0
National Health and Medical Research Council
Address [1] 284131 0
GPO Box 1421
Canberra ACT 2601
Country [1] 284131 0
Australia
Primary sponsor type
Hospital
Name
Sydney Local Health District
Address
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 269092 0
Hospital
Name [1] 269092 0
The Prince Charles Hospital
Address [1] 269092 0
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Country [1] 269092 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272090 0
Sydney Local Health Network Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 272090 0
Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 272090 0
Australia
Date submitted for ethics approval [1] 272090 0
Approval date [1] 272090 0
24/02/2011
Ethics approval number [1] 272090 0
X11-0009

Summary
Brief summary
The purpose of the study is to assess the efficacy of an oral antibiotic (Azithromycin) and an inhaled mucus-clearance agent (nebulised salt water, known as hypertonic saline) in people with bronchiectasis that is not due to cystic fibrosis. The interventions will be administered over a 6-month period. The investigators hypothesise that each intervention will improve the quality of life of people with bronchiectasis by reducing the severity of the chronic lung infection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33335 0
Address 33335 0
Country 33335 0
Phone 33335 0
Fax 33335 0
Email 33335 0
Contact person for public queries
Name 16582 0
Prof Peter Bye
Address 16582 0
Respiratory Medicine
11 West
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 16582 0
Australia
Phone 16582 0
+61 2 9515 7427
Fax 16582 0
Email 16582 0
peter.bye@sydney.edu.au
Contact person for scientific queries
Name 7510 0
Prof Peter Bye
Address 7510 0
Respiratory Medicine
11 West
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 7510 0
Australia
Phone 7510 0
+61 2 9515 7427
Fax 7510 0
Email 7510 0
peter.bye@sydney.edu.au

No data has been provided for results reporting
Summary results
Not applicable