drugset / Trial / NCT01619657
Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to assess whether 6% hypertonic saline (HS) is a safe and effective preventive therapy in newborns and infants with cystic fibrosis (CF).
Timeline
- Start
- 2012-06
- Primary completion
- 2016-11
- Completion
- 2017-10
Publications
- 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.
- Stahl M, Wielputz MO, Ricklefs I, Dopfer C, Barth S, Schlegtendal A, Graeber SY, Sommerburg O, Diekmann G, Husing J, Koerner-Rettberg C, Nahrlich L, Dittrich AM, Kopp MV, Mall MA. Preventive Inhalation of Hypertonic Saline in Infants with Cystic Fibrosis (PRESIS). A Randomized, Double-Blind, Controlled Study. Am J Respir Crit Care Med. 2019 May 15;199(10):1238-1248. doi: 10.1164/rccm.201807-1203OC.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hypertonic saline | Unknown | 4 ml | Inhaled |
| Subject | Hypertonic saline | Unknown | 6 % | Inhaled |
| Comparator | sodium chloride | Unknown | 0.9 % | Inhaled |
| Comparator | sodium chloride | Unknown | 4 ml | Inhaled |