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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.