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Vasodilator

Nitric oxide gas at 160 ppm for Cystic Fibrosis

Phase 2
Waitlist Available
Research Sponsored by Novoteris, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 days
Awards & highlights

Summary

Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo control arm.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in FEV1 % predicted from baseline to Day 15
Secondary outcome measures
Counts of CFRSD-CRISS symptom scores for each symptom from evening prior to Day 1 to each day of the study (Days 1-35)
Mean absolute change in FEV1 % predicted from baseline to Days 10 and 36.
Mean absolute change in FEV1% from baseline to Day 15 in the NO group (within group test).
+9 more

Side effects data

From 2021 Phase 4 trial • 519 Patients • NCT03081052
28%
Venous Thromboemolic DVT
13%
Venous Thromboembolic Other
11%
New Onset Atrial Fibrillation
9%
All Cause Mortality
6%
Arterial Thromboembolic CVA/Stroke
5%
Venous Thromboembolic PE
3%
Arterial Thromboembolic Mesenteric Ischemia
2%
Arterial Thromboembolic Myocardial Infarction
2%
Upper GI Bleed
1%
Lower GI Bleed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lung Transplant With iNO
Lung Transplant With iEPO
Heart Transplant & LVAD Implantation With iNO
Heart Transplant & LVAD Implantation With iEPO

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitric oxide gas at 160 ppmExperimental Treatment1 Intervention
Nitric oxide gas at 160 ppm inhaled four times daily for 30 min delivered with air as the carrier via nasal inhalation for a total of 7.5 days. Total dose of 2400 ppm hours.
Group II: Breathing 20.3% oxygenPlacebo Group1 Intervention
Breathing 20.3% oxygen inhaled four times daily for 30 min delivered with air as the carrier via nasal inhalation for a total of 7.5 days.. 100% nitrogen will be injected into the breathing circuit (instead of 99.5% nitrogen and 0.5% NO).

Find a Location

Who is running the clinical trial?

Novoteris, LLCLead Sponsor
Cystic Fibrosis FoundationOTHER
192 Previous Clinical Trials
37,690 Total Patients Enrolled
185 Trials studying Cystic Fibrosis
34,793 Patients Enrolled for Cystic Fibrosis
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,817 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
18 Patients Enrolled for Cystic Fibrosis
~6 spots leftby Sep 2025
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