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Anti-Infective Closed to Enrollment

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

This study is taking place at multiple care centers across the U.S. It will look at the effectiveness of the inhaled drug nitric oxide in adults with cystic fibrosis who are taking an inhaled antibiotic.

 This study is placebo-controlled, meaning that some participants will receive inhaled nitric oxide, and others will receive placebo. In this study, researchers will test the effectiveness of inhaled nitric oxide by measuring lung function. They will also test sputum cultures to see if there is a reduction in bacteria.This study is for adults with CF who are chronically infected with Pseudomonas aeruginosa, Staphylococcus aureus or Stenotrophomonas maltophilia. This study may require lung function tests, sputum samples and/or other measures.

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 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

Study Sites

  • Closed to Enrollment

    California

    Children's Hospital of Los Angeles, Los Angeles, CA 90027

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Washington

    University of Washington Medical Center, Seattle, WA 98195

  • Closed to Enrollment

    Wisconsin

    Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226

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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