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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00277537




Registration number
NCT00277537
Ethics application status
Date submitted
13/01/2006
Date registered
16/01/2006
Date last updated
29/08/2008

Titles & IDs
Public title
Safety and Efficacy of Bronchitol in Bronchiectasis
Scientific title
A Phase III Multicenter, Randomised, Parallel, Placebo-Controlled, Double-Blind Study to Investigate the Safety and Efficacy of Treatment With Bronchitol (Dry Powder Mannitol) in the Symptomatic Treatment of Bronchiectasis.
Secondary ID [1] 0 0
DPM-B-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mannitol
Treatment: Drugs - placebo

Experimental: 1 -

Other: 2 -


Treatment: Drugs: Mannitol
320mg BD 12 weeks followed by 40 weeks open label

Treatment: Drugs: placebo
BD for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24 hour sputum clearance
Timepoint [1] 0 0
24 hours / 12 weeks
Primary outcome [2] 0 0
Quality of Life SGRQ
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
bronchiectasis symptoms
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
cough severity
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
exercise capacity
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
lung function, including gas transfer
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
antibiotic use
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
bronchial wall thickening and inflammation
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
adverse events
Timepoint [7] 0 0
12 weeks / 12 months
Secondary outcome [8] 0 0
haematology, biochemistry,
Timepoint [8] 0 0
12 weeks / 12 months
Secondary outcome [9] 0 0
sputum microbiology quantitative and qualitative
Timepoint [9] 0 0
12 weeks / 12 months

Eligibility
Key inclusion criteria
* Non cystic fibrosis bronchiectasis
* Have FEV1 50% - 80% predicted and =1.0L
* Have chronic sputum production of >10 mL per day on the majority of days in the 3 months prior to study entry
Minimum age
15 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Be using hypertonic saline or mucolytic pharmacological agents concurrently or in the 4 weeks prior to study entry
* Have airway hyperresponsiveness as defined by a positive Aridol challenge

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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
354
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown Sydney
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 0 0
Bankstown Hospital - Sydney
Recruitment hospital [7] 0 0
Mater Adult Hospital - Brisbane
Recruitment hospital [8] 0 0
Cairns Base Hospital - Cairns
Recruitment hospital [9] 0 0
Repatriation General Hospital - Adelaide
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Burnside War Memorial Hospital - Toorak Gardens, Adelaide
Recruitment hospital [12] 0 0
Peninsula Health Frankston Hospital - Frankston
Recruitment hospital [13] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [14] 0 0
AARI Sir Charles Gairdner Hospital - Perth
Recruitment hospital [15] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Camperdown Sydney
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Newcastle
Recruitment postcode(s) [5] 0 0
- St Leonards
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment postcode(s) [7] 0 0
- Brisbane
Recruitment postcode(s) [8] 0 0
- Cairns
Recruitment postcode(s) [9] 0 0
- Adelaide
Recruitment postcode(s) [10] 0 0
- Toorak Gardens, Adelaide
Recruitment postcode(s) [11] 0 0
- Frankston
Recruitment postcode(s) [12] 0 0
- Melbourne
Recruitment postcode(s) [13] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Northern Ireland
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Cambridge
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Leicester
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Manchester
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Syntara
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.
Trial website
https://clinicaltrials.gov/study/NCT00277537
Trial related presentations / publications
Bilton D, Daviskas E, Anderson SD, Kolbe J, King G, Stirling RG, Thompson BR, Milne D, Charlton B; B301 Investigators. Phase 3 randomized study of the efficacy and safety of inhaled dry powder mannitol for the symptomatic treatment of non-cystic fibrosis bronchiectasis. Chest. 2013 Jul;144(1):215-225. doi: 10.1378/chest.12-1763.
Public notes

Contacts
Principal investigator
Name 0 0
Brett Charlton
Address 0 0
Pharmaxis Ltd Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00277537