CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Nitric Oxide for Inhalation +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00570349
NCT00570349Phase 2Completed
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Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis

Mallinckrodt·interventional·Posted Dec 10, 2007·Updated Nov 13, 2019

In Brief

A Phase 2 clinical trial evaluating Nitric Oxide for Inhalation and Nitrogen for Cystic Fibrosis. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2007
Enrollment StartJul 1, 2004
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.6 years ago

Interventions

Nitric Oxide for Inhalationdrug

Nitric oxide will be administered at 20 ppm via nasal cannula over a 44 hour period.

Nitric Oxide for Inhalationdrug

Nitric oxide will be administered at 40 ppm via nasal cannula over a 44 hours period.

Nitrogendrug

100% nitrogen (placebo) will be administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period.