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Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease

NCT02730793 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-01-28

Study results available
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Summary

This study is designed as a masked, two center, randomized, placebo-controlled pilot study to evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential subjects will be identified in each site's CF clinic.

Conditions

Interventions

DRUG

Oral Aztreonam

Standard Therapy Comparator (Oral Cayston 75mg three times a day)

DRUG

Nasal Aztreonam

Study Therapy (nasal Aztreonam 75mg twice per day)

DRUG

Nasal Placebo

Placebo (nasal saline twice per day)

Sponsors & Collaborators

  • Eastern Virginia Medical School

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Bruce K Rubin, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-09-19
Completion
2019-09-19
FDA Drug
Yes

Countries

  • United States

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 NCT02730793 on ClinicalTrials.gov