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Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02694393
Recruitment Status : Recruiting
First Posted : February 29, 2016
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
Mast Therapeutics, Inc.
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Joseph Pilewski, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: sodium nitrite Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Inhaled Sodium Nitrite as an Antimicrobial for Pseudomonas Infection in Cystic Fibrosis
Study Start Date : February 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: sodium nitrite
Inhalation of 46 or 80 mg of sodium nitrite twice daily for four weeks
Drug: sodium nitrite
inhalation of 46 or 80 mg of sodium nitrite by electronic nebulization




Primary Outcome Measures :
  1. Pulmonary Function [ Time Frame: three times over 4 weeks (Day 0, Day 7, and Week 4) ]
    change in forced expiratory volume in one second (FEV1) after inhalation will assess safety


Secondary Outcome Measures :
  1. exhaled Nitric Oxide [ Time Frame: three times over 4 weeks (Day 0, Day 7, and Week 4) ]
    concentration of nitric oxide in exhaled breath

  2. sputum nitrite concentration [ Time Frame: three times over 4 weeks (Day 0, Day 7 and Week 4) ]
    concentration of nitrite in sputum

  3. Pseudomonas density in sputum [ Time Frame: two times over 4 weeks (Day 0 and Week 4) ]
    density of Pseudomonas in sputum

  4. CF questionnaire - Respiratory [ Time Frame: two times over 4 weeks (Day 0 and Week 4) ]
    respiratory symptom questionnaire



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cystic Fibrosis and at least two sputum cultures demonstrating Pseudomonas in the last 12 months

Exclusion Criteria:

  • use of supplemental oxygen, FEV1 < 40% predicted, inability to discontinue inhaled antibiotics for 8 weeks,
  • hospitalization within 4 weeks prior to enrollment,
  • change in maintenance CF therapies within 2 weeks of enrollment,
  • severe anemia, significant chronic liver disease, severe pulmonary hypertension, prior organ transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694393


Contacts
Contact: Joseph M Pilewski, MD 412-692-5872 pilewskijm@upmc.edu
Contact: Elizabeth Hartigan, MPH, RN 412-692-7060 elizabeth.hartigan@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elizabeth Hartigan, MPH, RN    412-692-7060    elizabeth.hartigan@chp.edu   
Contact    412-692-7042      
Principal Investigator: Joseph M Pilewski, MD         
Comprehensive Lung Center - Falk Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Joseph M Pilewski, MD         
Sponsors and Collaborators
Schmidhofer, Mark, MD
Mast Therapeutics, Inc.
Cystic Fibrosis Foundation Therapeutics
Investigators
Principal Investigator: Joseph Pilewski, MD University of Pittsburgh

Publications:
Responsible Party: Joseph Pilewski, Associate Professor of Medicine and Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02694393     History of Changes
Other Study ID Numbers: PRO15040062
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Infective Agents
Anti-Bacterial Agents