The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis

Status Completed

Clinical 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. 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

• NCT number: NCT00271310
• Study type: Interventional
• Source: Royal Prince Alfred Hospital, Sydney, Australia
• Status: Completed
• Phase: Phase 3
• Start date: September 2000
• Completion date: November 2003