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Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways

NCT01404234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2014-05-29

Study results available
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Summary

This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.

Conditions

Interventions

DRUG

AZLI

AZLI 75 mg was administered 3 times daily via the investigational nebulizer.

Sponsors & Collaborators

Principal Investigators

  • Mark Bresnik, M.D. · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • France
  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT01404234 on ClinicalTrials.gov