drugset / Trial / NCT00570349

Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis

NCT00570349

Phase 1/2 Completed 18 enrolled Mallinckrodt
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the trial is to assess the safety and tolerability of inhaled nitric oxide (NO) when administered by nasal cannula over a 44 hour period to clinically stable Cystic Fibrosis (CF) subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in forced expiratory volume in one second (FEV1), or an increase in methemoglobin.

Timeline

Start
2004-07
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 20 ppm Inhaled
Subject Nitric Oxide Other / unclassified 40 ppm Inhaled

Indications