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Anti-Infective Completed with Results

Phase 2 study of inhaled nitric oxide in people with CF (Novoteris NO-CF-02E)

This study took place at multiple care centers across the U.S. It evaluated the effectiveness of the inhaled drug nitric oxide in adults with cystic fibrosis.

 This study was placebo-controlled, meaning that some participants received inhaled nitric oxide, and others received placebo. In this study, researchers tested the effectiveness of inhaled nitric oxide by measuring lung function. They also tested sputum cultures to see if inhaled nitric oxide reduces bacteria.This study enrolled adults with CF who were chronically infected with Pseudomonas aeruginosa, Staphylococcus aureus or Stenotrophomonas maltophilia. 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    35 to 85%

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

To participate, adults with CF must have taken an inhaled antibiotic for at least three months prior to beginning the study (for cycled antibiotics, participants must have completed two cycles). This study is for people who are chronically infected with Pseudomonas aeruginosa, Staphylococcus aureus or Stenotrophomonas maltophilia.

Study Results

  • What We Learned:

    This study was concluded in 2020.  As of February, 2025 no results are publicly available. 

  • Primary Findings:

    Effectiveness:

    Safety:

  • Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    43 days

  • Number of Study Visits:

    10

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    35 to 85%

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

To participate, adults with CF must have taken an inhaled antibiotic for at least three months prior to beginning the study (for cycled antibiotics, participants must have completed two cycles). This study is for people who are chronically infected with Pseudomonas aeruginosa, Staphylococcus aureus or Stenotrophomonas maltophilia.

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