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Sponsors and Collaborators: |
Royal Prince Alfred Hospital, Sydney, Australia Cystic Fibrosis Foundation National Health and Medical Research Council, Australia Cystic Fibrosis Trust |
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Information provided by: | Royal Prince Alfred Hospital, Sydney, Australia |
ClinicalTrials.gov Identifier: | NCT00271310 |
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.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: hypertonic saline |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis |
Estimated Enrollment: | 164 |
Study Start Date: | September 2000 |
Estimated Study Completion Date: | November 2003 |
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.
Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Peter T P Bye, PhD | Royal Prince Alfred Hospital, Sydney, Australia |
Study ID Numbers: | X95-0118B, 97/31391 |
Study First Received: | December 29, 2005 |
Last Updated: | October 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00271310 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes |