drugset / Trial / NCT00271310
The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Phase 3
Completed
164 enrolled
Royal Prince Alfred Hospital, Sydney, Australia
Cystic Fibrosis Foundation · collabCystic Fibrosis Trust · collabNational Health and Medical Research Council, Australia · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2000-09
- Primary completion
- —
- Completion
- 2003-11
Outcome
Missed primary endpoint
paper did not differ significantly between groups (P=0.79). PMID 16421364 ↗
Publications
- Results 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.
- Wark 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hypertonic saline | Unknown | 7 % | Inhaled |