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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID: NCT00570349
Run by: Mallinckrodt
People needed: 18
Starts: 2004-07-01
Expected to finish: 2008-12-01
Last updated by the study team: 2019-11-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Confirmed diagnosis of CF
12 years of age and older
FEV1 greater than 40% of predicted
Resting awake oxygen saturation of at least 88%
Stable pulmonary disease as defined by both clinical impression and having had no recent hospitalizations or changes in antibiotic regimen within 1 month prior to enrollment
Signed informed consent form

You may not qualify if…

Pulmonary exacerbation resulting in antibiotic treatment (except prophylactic antibiotics) within 1 month of enrollment
Isolation of B. cepacia from a respiratory tract culture within 6 months
Severe nasal obstruction at the time of screening
Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
Pregnancy (a negative pregnancy test must be documented prior to enrollment if applicable)
Patients who have received treatment with nitric oxide for inhalation within 24 hours prior to study initiation or other investigational medications within 24 hours.

Where it is running

The Children's Hospital — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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