Phase 2
N=18
Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00570349 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels — 0.4; 0.5; 0.3; 0.3 Percent of Methemoglobin Level
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nitric Oxide for Inhalation (Drug); Nitrogen (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of Drug, Assessed by Change in Methemoglobin Levels |
0.4; 0.5; 0.3; 0.3; 0.1; 0.4 | — |
| PRIMARY Change in Oxygen Saturation |
95.5; 94.8; 95.5; 95.7; 95.8; 97.0 | — |
| PRIMARY Change in Forced Expiratory Volume in 1 Second (FEV1) |
3.4; 3.1; 3.0; 3.5; 3.1; 3.0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00570349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.