BronchiectasisPhase 4NCT00749866
Long Term Nebulised Gentamicin in Patients With Bronchiectasis
A Phase 4 study testing Gentamicin and Saline in people with Bronchiectasis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Gentamicin and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2007to Aug 2009
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bronchiectasis confirmed by HRCT of the chest
- Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study start date)
- Aged 18-70
- Chronic sputum production > 5 mls for the majority of days in 3 months before enrolment
- Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst clinically stable
- At least two exacerbations in the past year
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- Patients able to tolerate a nebulized gentamicin challenge
- FEV1 > 30% predicted
- Smoking < 20 pack year history and ex-smokers >1 year.
Who cannot join
- Cystic fibrosis
- Emphysema on HRCT chest
- Thoracic surgery within the past 1 year
- Allergic bronchopulmonary aspergillosis
- Poorly controlled asthma ( > 20% diurnal variation in peak expiratory flows despite treatment)
- Unstable angina or uncontrolled congestive cardiac failure
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- Active malignancy
- Pregnancy or breast feeding
- Creatinine clearance < 30 mls/minute
- Vestibular instability
- Previous documented intolerance to aminoglycosides
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA
About this study
Official title: Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.
- Conditions
- Bronchiectasis
- Being tested
- Gentamicin, Saline
- Keywords
- Nebulised antibiotics, Non cystic fibrosis bronchiectasis, Bacterial Load, Inflammation, Quality of Life, Side Effects
- Medical subject headings
- Bronchiectasis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentamicinDrug
Nebulised 80mg twice daily
SalineDrug
Nebulised 4mls 0.9% Saline twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Nebulised Gentamicin Receives: Drug: Gentamicin |
| 2 | Placebo comparator | Nebulised 0.9% Saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in bacterial load
Measured: 1 year
Secondary outcomes (5)
airways and systemic inflammation
Measured: 1 year
Spirometry and exercise capacity
Measured: 1 year
Exacerbation frequency
Measured: 1 year
Health Related Quality of Life
Measured: 1 Year
Long term safety with nebulised Gentamicin
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Investigators
- Adam T Hill, MBChB MD, Principal investigator, NHS Lothian and University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749866
- Sponsor's protocol ID
- CZB/4/451
- Status last verified
- Aug 2010
- First submitted
- 8 Sep 2008
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.
PubMed 22744718Murray MP, Govan JR, Doherty CJ, Simpson AJ, Wilkinson TS, Chalmers JD, Greening AP, Haslett C, Hill AT. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):491-9. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.
PubMed 20870753
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT00749866
- Acronym / sponsor ID
- CZB/4/451
- Conditions
- Bronchiectasis
- Keywords
- Nebulised antibiotics, Non cystic fibrosis bronchiectasis, Bacterial Load, Inflammation, Quality of Life, Side Effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Sep 2008 (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.
The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GentamicinNebulised Gentamicin |
| 2 | Placebo comparator | Drug: SalineNebulised 0.9% Saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bronchiectasis confirmed by HRCT of the chest
- Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study start date)
- Aged 18-70
- Chronic sputum production > 5 mls for the majority of days in 3 months before enrolment
- Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst clinically stable
Key exclusion criteria (11 listed)
- Cystic fibrosis
- Emphysema on HRCT chest
- Thoracic surgery within the past 1 year
- Allergic bronchopulmonary aspergillosis
- Poorly controlled asthma ( > 20% diurnal variation in peak expiratory flows despite treatment)
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 |
|---|---|---|
| GentamicinNebulised 80mg twice daily | Drug | 1 |
| SalineNebulised 4mls 0.9% Saline twice daily | Drug | 2 |
Primary outcome
Reduction in bacterial load
Time frame: 1 year
5 secondary outcomes
airways and systemic inflammation
Time frame: 1 year
Spirometry and exercise capacity
Time frame: 1 year
Exacerbation frequency
Time frame: 1 year
Health Related Quality of Life
Time frame: 1 Year
Long term safety with nebulised Gentamicin
Time frame: 1 Year
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 10 Aug 2010.
- Derived from this study: PubMed 22744718Chalmers JD, Smith MP, McHugh BJ, Doherty C, Govan JR, Hill AT. Short- and long-term antibiotic treatment reduces airway and systemic inflammation in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2012 Oct 1;186(7):657-65. doi: 10.1164/rccm.201203-0487OC. Epub 2012 Jun 28.
- Derived from this study: PubMed 20870753Murray MP, Govan JR, Doherty CJ, Simpson AJ, Wilkinson TS, Chalmers JD, Greening AP, Haslett C, Hill AT. A randomized controlled trial of nebulized gentamicin in non-cystic fibrosis bronchiectasis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):491-9. doi: 10.1164/rccm.201005-0756OC. Epub 2010 Sep 24.
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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.
Adam T Hill, MBChB MD principal investigator
NHS Lothian and University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gentamicin and Saline in people with Bronchiectasis, run by University of Edinburgh at 1 site in United Kingdom.
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 9 inclusion and 11 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 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reduction in bacterial load (time frame: 1 year). 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 NCT00749866, which also lists 2 linked publications.
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 10 Aug 2010.