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| Descriptive Information Fields | |||||
| Brief Title † | The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis | ||||
| Official Title † | The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis | ||||
| Brief 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. 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. |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Lung function (FEV1, FVC, FEF25-75) | ||||
| Secondary Outcome Measure † | 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 |
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| Condition † | Cystic Fibrosis | ||||
| Intervention † | Drug: hypertonic saline | ||||
| MEDLINE PMIDs | 16421364 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 164 | ||||
| Start Date † | September 2000 | ||||
| Completion Date | November 2003 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00271310 | ||||
| Organization ID | X95-0118B | ||||
| Secondary IDs †† | 97/31391 | ||||
| Study Sponsor † | Royal Prince Alfred Hospital, Sydney, Australia | ||||
| Collaborators †† | Cystic Fibrosis Foundation National Health and Medical Research Council, Australia Cystic Fibrosis Trust |
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| Investigators † |
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| Information Provided By | Royal Prince Alfred Hospital, Sydney, Australia | ||||
| Verification Date | October 2006 | ||||
| First Received Date † | December 29, 2005 | ||||
| Last Updated Date | October 6, 2006 | ||||