BronchiectasisPhase 3NCT00484263
The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis
A Phase 3 study testing Hypertonic saline 6% - in people with Bronchiectasis, run by The Alfred at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether the daily inhalation of nebulised hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase the quality of life for people with non cystic fibrosis bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Hypertonic saline 6% -
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2007to Oct 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of bronchiectasis on high resolution computer tomography
- at least 2 respiratory exacerbations per year over the past 2 years
- producing sputum daily
- in a stable clinical state
- over 18 years of age.
Who cannot join
- cystic fibrosis
- Positive response to hypertonic saline challenge - FEV 1 decreased by ≥ 15%
- FEV 1 ≤ 1L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.
The purpose of this study is to determine whether the daily inhalation of nebulised hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase the quality of life for people with non cystic fibrosis bronchiectasis.
Read the detailed description
Bronchiectasis is a disabling, chronic respiratory condition which significantly impacts on the quality of life of patients who present with chronic sputum production and respiratory infections. The occurrence of pulmonary infections is a strong predictor of morbidity and mortality in this group of people so the primary goal of treatment is to prevent infections caused by the presence of sputum in their lungs.
Physiotherapy is a major aspect of their management and focuses on teaching appropriate airways clearance techniques. Traditionally, the physiotherapy management of sputum retention due to bronchiectasis has included the active cycle of breathing technique which has been demonstrated to enhance airways clearance. For some patients, this treatment is not adequate. The use of nebulised hypertonic saline has been used for patients with cystic fibrosis and has been demonstrated to improve sputum removal and lung function.
The aim of this project is to determine the long term effect of the daily inhalation of hypertonic saline on respiratory infections, quality of life, lung function and hospital admissions in patients with non cystic fibrosis bronchiectasis. Hypertonic saline has been shown to be beneficial as a once only treatment in this patient group, but its' long term effects have not been studied.
Participants will be randomised to two groups - those receiving hypertonic saline (6%) and those receiving isotonic saline (0.9%) - and will be blinded to the treatment that they are receiving. They will be given nebuliser equipment and will be instructed how and when to inhale their medication.
Objective measures will be taken by a blinded assessor before the commencement of the project and then at 3 months, 6 months and 12 months post commencement.
- Conditions
- Bronchiectasis
- Being tested
- Hypertonic saline 6% -
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline 6% -Drug
Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Hypertonic saline 6% - |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pulmonary exacerbations
Measured: One year
Secondary outcomes (1)
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Investigators
- Anne Holland, PhD, BAppSc, Study chair, The AlfredCaroline H Nicolson, MPhysio, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484263
- Sponsor's protocol ID
- T10716
- Status last verified
- Jun 2011
- First submitted
- 7 Jun 2007
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elkins MR, Robinson M, Rose BR, Harbour C, Moriarty CP, Marks GB, Belousova EG, Xuan W, Bye PT; National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006 Jan 19;354(3):229-40. doi: 10.1056/NEJMoa043900.
PubMed 16421364Kellett F, Redfern J, Niven RM. Evaluation of nebulised hypertonic saline (7%) as an adjunct to physiotherapy in patients with stable bronchiectasis. Respir Med. 2005 Jan;99(1):27-31. doi: 10.1016/j.rmed.2004.05.006.
PubMed 15672845Nicolson CH, Stirling RG, Borg BM, Button BM, Wilson JW, Holland AE. The long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis. Respir Med. 2012 May;106(5):661-7. doi: 10.1016/j.rmed.2011.12.021. Epub 2012 Feb 19.
PubMed 22349069
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.
- ClinicalTrials.gov ID
- NCT00484263
- Acronym / sponsor ID
- T10716
- Conditions
- Bronchiectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Jun 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.
The purpose of this study is to determine whether the daily inhalation of nebulised hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase the quality of life for people with non cystic fibrosis bronchiectasis.
Detailed description
Bronchiectasis is a disabling, chronic respiratory condition which significantly impacts on the quality of life of patients who present with chronic sputum production and respiratory infections. The occurrence of pulmonary infections is a strong predictor of morbidity and mortality in this group of people so the primary goal of treatment is to prevent infections caused by the presence of sputum in their lungs.
Physiotherapy is a major aspect of their management and focuses on teaching appropriate airways clearance techniques. Traditionally, the physiotherapy management of sputum retention due to bronchiectasis has included the active cycle of breathing technique which has been demonstrated to enhance airways clearance. For some patients, this treatment is not adequate. The use of nebulised hypertonic saline has been used for patients with cystic fibrosis and has been demonstrated to improve sputum removal and lung function.
The aim of this project is to determine the long term effect of the daily inhalation of hypertonic saline on respiratory infections, quality of life, lung function and hospital admissions in patients with non cystic fibrosis bronchiectasis. Hypertonic saline has been shown to be beneficial as a once only treatment in this patient group, but its' long term effects have not been studied.
Participants will be randomised to two groups - those receiving hypertonic saline (6%) and those receiving isotonic saline (0.9%) - and will be blinded to the treatment that they are receiving. They will be given nebuliser equipment and will be instructed how and when to inhale their medication.
Objective measures will be taken by a blinded assessor before the commencement of the project and then at 3 months, 6 months and 12 months post commencement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Hypertonic saline 6% - |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of bronchiectasis on high resolution computer tomography
- at least 2 respiratory exacerbations per year over the past 2 years
- producing sputum daily
- in a stable clinical state
- over 18 years of age.
Key exclusion criteria (3 listed)
- cystic fibrosis
- Positive response to hypertonic saline challenge - FEV 1 decreased by ≥ 15%
- FEV 1 ≤ 1L
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 |
|---|---|---|
| Hypertonic saline 6% -Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months | Drug | 1 |
Primary outcome
Number of pulmonary exacerbations
Time frame: One year
1 secondary outcome
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests
Time frame: One 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 23 Jun 2011.
- Background: PubMed 16421364Elkins MR, Robinson M, Rose BR, Harbour C, Moriarty CP, Marks GB, Belousova EG, Xuan W, Bye PT; National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006 Jan 19;354(3):229-40. doi: 10.1056/NEJMoa043900.
- Background: PubMed 15672845Kellett F, Redfern J, Niven RM. Evaluation of nebulised hypertonic saline (7%) as an adjunct to physiotherapy in patients with stable bronchiectasis. Respir Med. 2005 Jan;99(1):27-31. doi: 10.1016/j.rmed.2004.05.006.
- Derived from this study: PubMed 22349069Nicolson CH, Stirling RG, Borg BM, Button BM, Wilson JW, Holland AE. The long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis. Respir Med. 2012 May;106(5):661-7. doi: 10.1016/j.rmed.2011.12.021. Epub 2012 Feb 19.
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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.
Anne Holland, PhD, BAppSc study chair
The Alfred
Caroline H Nicolson, MPhysio principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic saline 6% - in people with Bronchiectasis, run by The Alfred at 1 site 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 5 inclusion and 3 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 23 Jun 2011. 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 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 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?
Number of pulmonary exacerbations (time frame: One 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 NCT00484263, which also lists 3 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 23 Jun 2011.