NCT02694393

Brief Summary

This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the burden of Pseudomonas.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 24, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

6.5 years

First QC Date

January 11, 2016

Results QC Date

July 21, 2023

Last Update Submit

June 18, 2024

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

  • Pulmonary Function

    forced expiratory volume in one second (FEV1) after inhalation will assess safety

    Day 7

  • Pulmonary Function

    forced expiratory volume in one second (FEV1) after inhalation will assess safety

    Day 28

Secondary Outcomes (6)

  • Exhaled Nitric Oxide

    Day 7

  • Exhaled Nitric Oxide

    Day 28

  • Sputum Nitrite Concentration

    day 7

  • Sputum Nitrite Concentration

    day 28

  • Pseudomonas Density in Sputum

    day 28

  • +1 more secondary outcomes

Study Arms (1)

sodium nitrite

EXPERIMENTAL

Inhalation of 46 or 80 mg of sodium nitrite twice daily for four weeks

Drug: sodium nitrite

Interventions

sodium nitriteDRUG

inhalation of 46 or 80 mg of sodium nitrite by electronic nebulization

Also known as: AIR001
sodium nitrite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cystic Fibrosis as documented by clinical features, and documentation of a positive sweat test or two disease causing mutation of the CF gene.

You may not qualify if:

  • use of supplemental oxygen, FEV1 \< 40% predicted, inability to discontinue inhaled antibiotics for 4 weeks,
  • hospitalization within 4 weeks prior to enrollment,
  • change in maintenance CF therapies within 4 weeks of enrollment,
  • severe anemia, significant chronic liver disease, severe pulmonary hypertension, prior organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Comprehensive Lung Center - Falk Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Major TA, Panmanee W, Mortensen JE, Gray LD, Hoglen N, Hassett DJ. Sodium nitrite-mediated killing of the major cystic fibrosis pathogens Pseudomonas aeruginosa, Staphylococcus aureus, and Burkholderia cepacia under anaerobic planktonic and biofilm conditions. Antimicrob Agents Chemother. 2010 Nov;54(11):4671-7. doi: 10.1128/AAC.00379-10. Epub 2010 Aug 9.

    PMID: 20696868BACKGROUND

  • Zemke AC, Shiva S, Burns JL, Moskowitz SM, Pilewski JM, Gladwin MT, Bomberger JM. Nitrite modulates bacterial antibiotic susceptibility and biofilm formation in association with airway epithelial cells. Free Radic Biol Med. 2014 Dec;77:307-16. doi: 10.1016/j.freeradbiomed.2014.08.011. Epub 2014 Sep 16.

    PMID: 25229185BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium Compounds

Limitations and Caveats

The study was terminated early due to expiration of investigational product and lack of a manufacturer.

Results Point of Contact

Title
Dr. Joseph Pilewski
Organization
University of Pittsburgh
pilewskijm@upmc.edu
(412) 692-2210‬

Study Officials

  • Joseph Pilewski, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Pediatrics

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 29, 2016

Study Start

February 1, 2016

Primary Completion

July 21, 2022

Study Completion

July 21, 2022

Last Updated

June 24, 2024

Results First Posted

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)