Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00277537