COPDPhase 1/2NCT00446667
A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD
A Phase 1/2 study testing mannitol in people with COPD and Exacerbation, run by Syntara at 2 sites in Australia.
Trial summary
COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- COPD, Exacerbation
- What is being tested?
- mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2006to Jun 2008
- Phase
- Phase 1/2
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV1 > 35% predicted
- COPD
- Exacerbation
- Inpatient
Who cannot join
- Pneumonia
- CO2 retention
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Royal Prince Alfred Hospital
Sydney, New South Wales, 2087
St George Hospital
Sydney, New South Wales
About this study
COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.
- Conditions
- COPD, Exacerbation
- Being tested
- mannitol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mannitolDrug
400mg BD for 2 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Measured: 2 days
Secondary outcomes (1)
safety
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Failed to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Barnes, MBBS FRACP, Principal investigator, Royal Prince Alfred Hospital NSW Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446667
- Sponsor's protocol ID
- DPM-COPD-HIP-101b
- Status last verified
- Sep 2016
- First submitted
- 12 Mar 2007
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT00446667
- Acronym / sponsor ID
- DPM-COPD-HIP-101b
- Conditions
- COPD, Exacerbation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failed to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Mar 2007 (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.
COPD is a major cause of ill health and death in Australia with 40,000 hospital admissions, and a national cost of $898,000,000 annually. The gold standard treatment of COPD is steroids for inflammation, antibiotics for infection and bronchodilators and oxygen for respiratory failure. However, associated mucus hypersecretion is responsible for much of the inflammation and infection. The use of pharmaceutical agents to assist in the early clearance of the retained mucus has been limited, primarily because of lack of demonstrated effect. There has been a recent development of interest in pursuing new therapies for improving mucociliary clearance and several studies have demonstrated that clinical outcomes can be improved when osmotic agents such as mannitol are added to standard treatments. The purpose of this study is to conduct a pilot safety study in patients with an acute exacerbation of COPD to determine if it is safe to administer inhaled mannitol for facilitating mucus clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mannitol |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FEV1 > 35% predicted
- COPD
- Exacerbation
- Inpatient
Key exclusion criteria (2 listed)
- Pneumonia
- CO2 retention
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 |
|---|---|---|
| mannitol400mg BD for 2 days | Drug | 1 |
Primary outcome
FEV1
Time frame: 2 days
1 secondary outcome
safety
Time frame: 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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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.
David Barnes, MBBS FRACP principal investigator
Royal Prince Alfred Hospital NSW Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mannitol in people with COPD and Exacerbation, run by Syntara at 2 sites in Australia.
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 4 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: withdrawn, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
FEV1 (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2016.