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Antimicrobial

sodium nitrite for Cystic Fibrosis

Phase 1 & 2
Waitlist Available
Led By Joseph Pilewski, MD
Research Sponsored by Schmidhofer, Mark, MD
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 three times over 4 weeks (day 0, day 7 and week 4)
Awards & highlights

Study Summary

This trial will study the effects of inhaled sodium nitrite in people with Cystic Fibrosis who also have chronic Pseudomonas infections.

Eligible Conditions
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three times over 4 weeks (day 0, day 7 and week 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and three times over 4 weeks (day 0, day 7 and week 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pulmonary Function
Secondary outcome measures
CF questionnaire - Respiratory
Pseudomonas density in sputum
exhaled Nitric Oxide
+1 more

Side effects data

From 2013 Phase 2 trial • 55 Patients • NCT01401517
21%
Headaches and dizziness
16%
Muscoskeletal and Connective Tissues
11%
GI Disorders
11%
Infections
5%
Investigations
100%
80%
60%
40%
20%
0%
Study treatment Arm
40 mg Sodium Nitrite
Placebo
80 mg Sodium Nitrite

Trial Design

1Treatment groups
Experimental Treatment
Group I: sodium nitriteExperimental Treatment1 Intervention
Inhalation of 46 or 80 mg of sodium nitrite twice daily for four weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sodium nitrite
2011
Completed Phase 3
~270

Find a Location

Who is running the clinical trial?

Cystic Fibrosis FoundationOTHER
187 Previous Clinical Trials
36,328 Total Patients Enrolled
180 Trials studying Cystic Fibrosis
33,391 Patients Enrolled for Cystic Fibrosis
Schmidhofer, Mark, MDLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Mast Therapeutics, Inc.Industry Sponsor
14 Previous Clinical Trials
2,481 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are volunteering for this research project?

"Unfortunately, this particular clinical trial is not presently looking for candidates. However, it was last edited on 7/7/2022 and may open up recruitment in the future. There are currently 433 other studies actively recruiting patients with cystic fibrosis and 4 trials testing sodium nitrite that are admitting participants."

Answered by AI

Are there other scientific papers that have been published on sodium nitrite?

"Currently, 4 ongoing clinical trials for sodium nitrite exist, and 0 of them are in Phase 3. Most of the locations conducting these trials are based out of Bronx, New york, but there are a total 7 different sites running these studies."

Answered by AI

Is it still possible to sign up for this research project?

"The clinical trial mentioned is not currently recruiting patients, based on the information provided by clinicaltrials.gov. The first posting was on February 1st, 2016 and the most recent edit was done on July 7th, 2022. 437 other trials are actively looking for participants."

Answered by AI

To your knowledge, does a study like this one exist?

"Since 2016, sodium nitrite has been studied in several clinical trials. The first one occurred in 2016 and was sponsored by Mast Therapeutics, Inc.. After the initial study involving 35 patients, sodium nitrite received approval for Phase 1 & 2 drug trials. Today, there are 4 active studies being conducted across 2 cities and 1 country."

Answered by AI
~4 spots leftby Mar 2025