Cystic FibrosisPhase 3NCT00271310
The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
A Phase 3 study testing hypertonic saline in people with Cystic Fibrosis, run by Royal Prince Alfred Hospital, Sydney, Australia.
Trial summary
The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- hypertonic saline
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Nov 2003
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CF (sweat tests/genotype)
- The subject, or their legal guardian for children under 18 years old, must provide written informed consent.
- The subject must be in stable clinical condition at the time of and for a period of 14 days prior to their recruitment into the study.
- Age > 6 years old
- FEV1 > 40% predicted for height, age and gender
- Proven or anticipated compliance with therapy or study protocol
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- Regular attendee at a Cystic Fibrosis Clinic (> 2 visits per year)
- Able to reproducibly perform lung function tests (spirometry)
- Relatively stable nutritional status (< 2 kg weight loss in last 6 months and < 5 kg weight loss in last year)
- Known to have "normal" (for CF subject) laboratory tests - haematology, biochemistry, immunology, coagulation, etc.
Who cannot join
- Requiring home oxygen (pO2 <55mmHg or pCO2 >50mmHg) or assisted ventilation.
- Considered "terminally ill" or listed for transplantation (either lung or liver). Subjects that are listed for transplant after being enrolled in the trial are eligible to continue in the trial.
- Subjects colonised with Burkholderia cepacia. However, if a subject becomes colonised with B. cepacia during the trial, they should continue in the trial. Subjects should be considered to be B. cepacia positive if they have had even a single lifetime isolate. In these subjects, spirometry should be measured on a dedicated spirometer.
- Cigarette smoker.
- Exposure to investigational drugs within the past 30 days.
- Major haemoptysis (> 60 mL in a single episode) within the last twelve months.
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- Concurrent illnesses eg. cor pulmonale, clinically significant liver disease (portal hypertension, varices).
- Known allergy to quinine sulphate, Glucose 6-phosphate dehydrogenase deficiency.
- Immune thrombocytopaenic purpura.
- Pregnant or lactating females.
- At risk females unwilling to use appropriate contraception to prevent pregnancy for the duration of their enrolment in the study.
About this study
The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.
Read the detailed description
The study intervention is nebulised hypertonic (7%) saline (Active) or nebulised normal (0.9%) saline (Control) twice per day for 336 days. At a screening visit, subjects will complete quality of life questionnaires, be questioned regarding their medical history, undergo physical examination and spirometry, and will be requested to provide a sputum sample. The subject is then supervised taking their first dose to ensure the correct procedure is used and there are no adverse effects. The subject then commences taking the trial solution at home, and once a week completes a diary card to monitor factors such as respiratory tract infections and medication use. Subsequent visits are scheduled at Days 28, 84, 168, 252, 334, and 336, at which the same investigation are performed as at the screening visit.
- Conditions
- Cystic Fibrosis
- Being tested
- hypertonic saline
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic salineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function (FEV1, FVC, FEF25-75)
Secondary outcomes (9)
Pulmonary exacerbations (therapy-defined and symptom-defined)(number and duration)
Total antibiotic-days
Absenteeism
Weight / body mass index
Quality of life
Quantitative microbiology of sputum
Aquisition and loss of organisms from sputum
Cyotkine assays in sputum
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2005 (estimated)
- Study startSep 2000
- Study completionNov 2003
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 Cystic FibrosisStudies 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
- Double blind
- Enrolment
- 164 participants
Sponsor and investigators
- Lead sponsor
- Royal Prince Alfred Hospital, Sydney, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Health and Medical Research Council, Australia, Cystic Fibrosis Trust
- Investigators
- Peter T P Bye, PhD, Principal investigator, Royal Prince Alfred Hospital, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271310
- Sponsor's protocol ID
- X95-0118B
- Other IDs
- 97/31391
- Status last verified
- Oct 2006
- First submitted
- 29 Dec 2005
- Last updated
- 9 Oct 2006
- Results posted
- No
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 16421364Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.
PubMed 37319354
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00271310
- Acronym / sponsor ID
- X95-0118B
- Conditions
- Cystic Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants
- Lead sponsor
- Royal Prince Alfred Hospital, Sydney, AustraliaUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, National Health and Medical Research Council, Australia, Cystic Fibrosis Trust
- Study start
- Sep 2000
- Study completion
- Nov 2003
- First posted
- 30 Dec 2005 (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 effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.
Detailed description
The study intervention is nebulised hypertonic (7%) saline (Active) or nebulised normal (0.9%) saline (Control) twice per day for 336 days. At a screening visit, subjects will complete quality of life questionnaires, be questioned regarding their medical history, undergo physical examination and spirometry, and will be requested to provide a sputum sample. The subject is then supervised taking their first dose to ensure the correct procedure is used and there are no adverse effects. The subject then commences taking the trial solution at home, and once a week completes a diary card to monitor factors such as respiratory tract infections and medication use. Subsequent visits are scheduled at Days 28, 84, 168, 252, 334, and 336, at which the same investigation are performed as at the screening visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed diagnosis of CF (sweat tests/genotype)
- The subject, or their legal guardian for children under 18 years old, must provide written informed consent.
- The subject must be in stable clinical condition at the time of and for a period of 14 days prior to their recruitment into the study.
- Age > 6 years old
- FEV1 > 40% predicted for height, age and gender
Key exclusion criteria (11 listed)
- Requiring home oxygen (pO2 <55mmHg or pCO2 >50mmHg) or assisted ventilation.
- Considered "terminally ill" or listed for transplantation (either lung or liver). Subjects that are listed for transplant after being enrolled in the trial are eligible to continue in the trial.
- Subjects colonised with Burkholderia cepacia. However, if a subject becomes colonised with B. cepacia during the trial, they should continue in the trial. Subjects should be considered to be B. cepacia positive if they have had even a single lifetime isolate. In these subjects, spirometry should be measured on a dedicated spirometer.
- Cigarette smoker.
- Exposure to investigational drugs within the past 30 days.
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 | Drug | – |
Primary outcome
Lung function (FEV1, FVC, FEF25-75)
9 secondary outcomes
Pulmonary exacerbations (therapy-defined and symptom-defined)(number and duration)
Total antibiotic-days
Absenteeism
Weight / body mass index
Quality of life
Quantitative microbiology of sputum
Aquisition and loss of organisms from sputum
Cyotkine assays in sputum
Adverse events
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 9 Oct 2006.
- Results publication: 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.
- Derived from this study: PubMed 37319354Wark P, McDonald VM, Smith S. Nebulised hypertonic saline for cystic fibrosis. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD001506. doi: 10.1002/14651858.CD001506.pub5.
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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.
Peter T P Bye, PhD principal investigator
Royal Prince Alfred Hospital, Sydney, Australia
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hypertonic saline in people with Cystic Fibrosis, run by Royal Prince Alfred Hospital, Sydney, 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 10 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 9 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Lung function (FEV1, FVC, FEF25-75). 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 NCT00271310, 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 9 Oct 2006.