drugset / Trial / NCT00570349
Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitric Oxide | Other / unclassified | 20 ppm | Inhaled |
| Subject | Nitric Oxide | Other / unclassified | 40 ppm | Inhaled |