drugset / Trial / NCT00709280
Infant Study of Inhaled Saline in Cystic Fibrosis
Completed
321 enrolled
CF Therapeutics Development Network Coordinating Center
Cystic Fibrosis Foundation · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and safe therapy in infants and young children with CF.
Timeline
- Start
- 2009-04
- Primary completion
- 2011-10
- Completion
- 2011-11
Outcome
Missed primary endpoint
paper did not reduce the rate of pulmonary exacerbations over the course of 48 weeks of treatment. PMID 22610452 ↗
Publications
- Results Rosenfeld M, Ratjen F, Brumback L, Daniel S, Rowbotham R, McNamara S, Johnson R, Kronmal R, Davis SD; ISIS Study Group. Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis: the ISIS randomized controlled trial. JAMA. 2012 Jun 6;307(21):2269-77. doi: 10.1001/jama.2012.5214.
- Subbarao P, Stanojevic S, Brown M, Jensen R, Rosenfeld M, Davis S, Brumback L, Gustafsson P, Ratjen F. Lung clearance index as an outcome measure for clinical trials in young children with cystic fibrosis. A pilot study using inhaled hypertonic saline. Am J Respir Crit Care Med. 2013 Aug 15;188(4):456-60. doi: 10.1164/rccm.201302-0219OC.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hypertonic saline | Unknown | 7 % | Inhaled |
| Comparator | sodium chloride | Unknown | 0.9 % | Inhaled |