The purpose of this study is to see if multiple courses of AI are safe for cystic fibrosis 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

Further Study Details: 

Primary Outcomes: adverse events (AEs); airway reactivity; vital signs; serum chemistry and hematology
Secondary Outcomes: PA CFU density in sputum; appearance or disappearance of other pathogens; minimum inhibitory concentration (MIC) of aztreonam; change in pulmonary function (FEV1, FVC, FEV25-75); quality of life; hospitalizations; body weight; missed school/work days; time to intravenous (IV) antibiotics
Expected Total Enrollment:  370

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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Compliance with CP-AI-004 or CP-AI-005 by taking at least 50% of expected study medication.
• Completion of CP-AI-004 or CP-AI-005 within the previous 30 days or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to AI tolerance.
• Ability to provide written informed consent/assent prior to initiation of study-related procedures.
• Ability to perform reproducible pulmonary function tests.

Exclusion Criteria:

• 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 AI in study CP-AI-004/005.
• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00128492

Debra Cibene      206-832-2098    dcibene@coruspharma.com

Arizona
      Phoenix,  Arizona,  United States; Not yet recruiting
Arkansas
      Little Rock,  Arkansas,  United States; Not yet recruiting
California
      Los Angeles,  California,  United States; Not yet recruiting
      Sacramento,  California,  United States; Not yet recruiting
      Oakland,  California,  United States; Not yet recruiting
      La Jolla,  California,  United States; Not yet recruiting
      Orange,  California,  United States; Not yet recruiting
      Palo Alto,  California,  United States; Not yet recruiting
Colorado
      Denver,  Colorado,  United States; Not yet recruiting
Connecticut
      Hartford,  Connecticut,  United States; Not yet recruiting
Florida
      Gainesville,  Florida,  United States; Not yet recruiting
      Miami,  Florida,  United States; Not yet recruiting
      Jacksonville,  Florida,  United States; Not yet recruiting
      St. Petersburg,  Florida,  United States; Not yet recruiting
      Orlando,  Florida,  United States; Not yet recruiting
Georgia
      Atlanta,  Georgia,  United States; Not yet recruiting
      Augusta,  Georgia,  United States; Not yet recruiting
Illinois
      Chicago,  Illinois,  United States; Not yet recruiting
      Park Ridge,  Illinois,  United States; Not yet recruiting
      Maywood,  Illinois,  United States; Recruiting
      Glenview,  Illinois,  United States; Not yet recruiting
Indiana
      Indianapolis,  Indiana,  United States; Not yet recruiting
Kansas
      Kansas City,  Kansas,  United States; Not yet recruiting
Maine
      Portland,  Maine,  United States; Not yet recruiting
Massachusetts
      Boston,  Massachusetts,  United States; Not yet recruiting
Michigan
      Detroit,  Michigan,  United States; Not yet recruiting
      Ann Arbor,  Michigan,  United States; Not yet recruiting
Minnesota
      Minneapolis,  Minnesota,  United States; Not yet recruiting
Nevada
      Las Vegas,  Nevada,  United States; Recruiting
New Jersey
      Morristown,  New Jersey,  United States; Not yet recruiting
New York
      Buffalo,  New York,  United States; Not yet recruiting
      New York,  New York,  United States; Not yet recruiting
      Stony Brook,  New York,  United States; Not yet recruiting
      Brooklyn,  New York,  United States; Not yet recruiting
      New Hyde Park,  New York,  United States; Not yet recruiting
      Valhalla,  New York,  United States; Not yet recruiting
      Albany,  New York,  United States; Not yet recruiting
Ohio
      Cleveland,  Ohio,  United States; Not yet recruiting
      Columbus,  Ohio,  United States; Recruiting
      Akron,  Ohio,  United States; Recruiting
      Dayton,  Ohio,  United States; Not yet recruiting
Oklahoma
      Oklahoma City,  Oklahoma,  United States; Not yet recruiting
Oregon
      Portland,  Oregon,  United States; Not yet recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  United States; Not yet recruiting
      Pittsburgh,  Pennsylvania,  United States; Not yet recruiting
      Hershey,  Pennsylvania,  United States; Not yet recruiting
Rhode Island
      Providence,  Rhode Island,  United States; Not yet recruiting
South Carolina
      Charleston,  South Carolina,  United States; Not yet recruiting
      Columbia,  South Carolina,  United States; Recruiting
Texas
      Houston,  Texas,  United States; Not yet recruiting
Washington
      Seattle,  Washington,  United States; Not yet recruiting
West Virginia
      Morgantown,  West Virginia,  United States; Not yet recruiting

Study chairs or principal investigators

Thomas Hofmann, MD, PhD,  Study Director,  Corus Pharma, Inc.   

Study ID Numbers:  CP-AI-006
Last Updated:  August 9, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128492
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23