drugset / Trial / NCT01377792

Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis

NCT01377792

Phase 4 Completed 71 enrolled Adelaida Lamas Ferreiro
RandomizedParallel-groupOpen-labelTreatment

Summary

A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.

Timeline

Start
2009-03
Primary completion
2011-05
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hypertonic saline Unknown 5 ml Inhaled
Comparator Hypertonic saline Unknown 10 ml Inhaled

Indications