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Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients

NCT02498535 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-03-05

No results posted yet for this study

Summary

Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo control arm.

Conditions

Interventions

DRUG

Nitric Oxide 160 ppm

Nitric Oxide 160 ppm

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Mallinckrodt

    collaborator INDUSTRY

  • Novoteris, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2020-06-01
Completion
2020-06-01
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02498535 on ClinicalTrials.gov