Status:
COMPLETED
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
Lead Sponsor:
Gilead Sciences
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
Detailed Description
People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacter...
Eligibility Criteria
Inclusion
- Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication.
- Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.
- Ability to provide written informed consent/assent prior to initiation of study-related procedures.
- Ability to perform reproducible pulmonary function tests.
Exclusion
- Use of any investigational medication or device between the last visit of CP-AI-005 or CP-AI-007 and Visit 1 of this study.
- Concurrent participation in a study of another investigational drug or device.
- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
- History of sputum or throat swab culture yielding Burkholderia cepacia in the previous 2 years.
- History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
- Inability to tolerate study medication in CP-AI-005 or CP-AI-007.
- Known local or systemic hypersensitivity to aztreonam.
- Inability to tolerate inhalation of a short acting beta-2 agonist.
- Abnormal renal or hepatic function based on results of most recent test.
- Female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control.
- Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00128492
Start Date
August 1 2005
End Date
January 1 2009
Last Update
May 19 2011
Active Locations (65)
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Birmingham, Alabama, United States
2
Anchorage, Alaska, United States
3
Phoenix, Arizona, United States
4
Little Rock, Arkansas, United States