BronchiectasisPhase 3NCT00277537
Safety and Efficacy of Bronchitol in Bronchiectasis
A Phase 3 study testing Mannitol in people with Bronchiectasis, run by Syntara at 22 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Mannitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 22 sitesin 3 countries
- Study dates
- Mar 2006to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
Australia15 sites
Repatriation General Hospital
Adelaide, South Australia
Royal Adelaide Hospital
Adelaide, South Australia
Mater Adult Hospital
Brisbane, Queensland
Cairns Base Hospital
Cairns, Queensland
Royal Prince Alfred Hospital
Camperdown Sydney, New South Wales
Canberra Hospital
Canberra, Australian Capital Territory
Peninsula Health Frankston Hospital
Frankston, Victoria
St George Hospital
Kogarah, New South Wales
The Alfred Hospital
Melbourne, Victoria
John Hunter Hospital
Newcastle, New South Wales
AARI Sir Charles Gairdner Hospital
Perth, Western Australia
Royal Perth Hospital
Perth, Western Australia
Royal North Shore Hospital
St Leonards, New South Wales
Bankstown Hospital
Sydney, New South Wales
Burnside War Memorial Hospital
Toorak Gardens, Adelaide, South Australia
United Kingdom5 sites
Belfast City Hospital
Belfast, Northern Ireland
Papworth Hospital
Cambridge
Glenfield Hospital
Leicester
North West Lung Centre, Wythshawe Hospital
Manchester
Norfolk and Norwich University Hospital
Norwich
New Zealand2 sites
Greenlane Hospital
Auckland
Middlemore Hospital
Auckland
About this study
Official 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.
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.
- Conditions
- Bronchiectasis
- Being tested
- Mannitol, placebo
- Keywords
- Mannitol
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
320mg BD 12 weeks followed by 40 weeks open label
placeboDrug
BD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Mannitol |
| 2 | Other | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour sputum clearance
Measured: 24 hours / 12 weeks
Quality of Life SGRQ
Measured: 12 weeks
Secondary outcomes (9)
bronchiectasis symptoms
Measured: 12 weeks
cough severity
Measured: 12 weeks
exercise capacity
Measured: 12 weeks
lung function, including gas transfer
Measured: 12 weeks
antibiotic use
Measured: 12 weeks
bronchial wall thickening and inflammation
Measured: 12 weeks
adverse events
Measured: 12 weeks / 12 months
haematology, biochemistry,
Measured: 12 weeks / 12 months
sputum microbiology quantitative and qualitative
Measured: 12 weeks / 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Brett Charlton, Study director, Pharmaxis Ltd Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277537
- Sponsor's protocol ID
- DPM-B-301
- Status last verified
- Aug 2008
- First submitted
- 13 Jan 2006
- Last updated
- 29 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23429964
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00277537
- Acronym / sponsor ID
- DPM-B-301
- Conditions
- Bronchiectasis
- Keywords
- Mannitol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mannitol |
| 2 | Other | Drug: placebo |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mannitol320mg BD 12 weeks followed by 40 weeks open label | Drug | 1 |
| placeboBD for 12 weeks | Drug | 2 |
Primary outcome
24 hour sputum clearance
Time frame: 24 hours / 12 weeks
Quality of Life SGRQ
Time frame: 12 weeks
9 secondary outcomes
bronchiectasis symptoms
Time frame: 12 weeks
cough severity
Time frame: 12 weeks
exercise capacity
Time frame: 12 weeks
lung function, including gas transfer
Time frame: 12 weeks
antibiotic use
Time frame: 12 weeks
bronchial wall thickening and inflammation
Time frame: 12 weeks
adverse events
Time frame: 12 weeks / 12 months
haematology, biochemistry,
Time frame: 12 weeks / 12 months
sputum microbiology quantitative and qualitative
Time frame: 12 weeks / 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2008.
- Derived from this study: PubMed 23429964Bilton 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.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Charlton study director
Pharmaxis Ltd Australia
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mannitol in people with Bronchiectasis, run by Syntara at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Australia, United Kingdom, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour sputum clearance (time frame: 24 hours / 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00277537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2008.