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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00128492 |
The purpose of this study is to see if multiple courses of AI are safe for cystic fibrosis (CF) patients with lung infections due to a bacteria called Pseudomonas aeruginosa (PA).
Condition | Intervention | Phase |
---|---|---|
Cystic Fibrosis |
Drug: aztreonam lysinate for inhalation (AI) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 3, Open-Label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3) |
Estimated Enrollment: | 400 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a PA. Treatment with antibiotics is used to stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, via IV, or inhaled as a mist. The purpose of this study is to evaluate whether AI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in CF patients with PA.
Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bruce Montgomery, MD | Corus Pharma, Inc. |
Study ID Numbers: | CP-AI-006 |
Study First Received: | August 8, 2005 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00128492 |
Health Authority: | United States: Food and Drug Administration |
cystic fibrosis Pseudomonas aeruginosa |
Aztreonam Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Anti-Infective Agents Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Pharmacologic Actions |