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Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

NCT00757237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2011-07-04

Study results available
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Summary

The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.

Conditions

Interventions

DRUG

Aztreonam for Inhalation Solution (AZLI)

Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer.

DRUG

Tobramycin Inhalation Solution (TIS)

Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.

Sponsors & Collaborators

  • Chiltern International Inc.

    collaborator INDUSTRY

  • ClinPhone, Inc.

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • Gilead Sciences

    lead INDUSTRY

Principal Investigators

  • Mark Bresnik, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-05-31
Completion
2010-11-30

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

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 NCT00757237 on ClinicalTrials.gov