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Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis

This study is currently recruiting participants.
Verified November 2017 by Joseph Pilewski, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02694393
First Posted: February 29, 2016
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Mast Therapeutics, Inc.
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Joseph Pilewski, University of Pittsburgh
  Purpose
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 Intervention Phase
Cystic Fibrosis Drug: sodium nitrite Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Joseph Pilewski, University of Pittsburgh:

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

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

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

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


Estimated Enrollment: 35
Study Start Date: February 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: January 11, 2016
First Posted: February 29, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017
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