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Study of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients With P. Aeruginosa
This study is ongoing, but not recruiting participants.
Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00128492
  Purpose

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

Genetics Home Reference related topics: cystic fibrosis
MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Aztreonam
U.S. FDA Resources
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)

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • adverse events (AEs)
  • airway reactivity
  • vital signs
  • serum chemistry and hematology

Secondary Outcome Measures:
  • Pseudomonas aeruginosa colony forming unit (PA CFU) density in sputum
  • appearance or disappearance of other pathogens
  • minimum inhibitory concentration (MIC) of aztreonam
  • change in pulmonary function (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC], FEV25-75)
  • quality of life
  • hospitalizations
  • body weight
  • missed school/work days
  • time to intravenous (IV) antibiotics

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Compliance with studies CP-AI-005 or CP-AI-007 by taking at least 50% of expected study medication.
  • Completion of CP-AI-005 or CP-AI-007 within the previous 60 days 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 Criteria:

  • Use of any investigational medication or device between the last visit of CP-AI-005/007 and Visit 1 of CP-AI-006.
  • 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 study CP-AI-005/007.
  • 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 is pregnant, lactating, or is 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 interfere with patient treatment, assessment, or compliance with the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128492

  Show 67 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Bruce Montgomery, MD Corus Pharma, Inc.
  More Information

Clinical trials in CF patients with P. aeruginosa  This link exits the ClinicalTrials.gov site

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

Keywords provided by Gilead Sciences:
cystic fibrosis
Pseudomonas aeruginosa

Study placed in the following topic categories:
Aztreonam
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009