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Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)

NCT02677701 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2021-06-28

Study results available
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Summary

This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.

Conditions

Interventions

DRUG

azithromycin

500mg tablet over-encapsulated to match placebo

DRUG

placebo (for azithromycin)

DRUG

inhaled tobramycin

clinically prescribed inhaled tobramycin used by subjects participating in the study

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • CF Therapeutics Development Network Coordinating Center

    collaborator NETWORK

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • David P Nichols, MD · National Jewish Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-21
Primary Completion
2020-02-13
Completion
2020-02-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT02677701 on ClinicalTrials.gov