Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00128492
• Date of registration: 08/08/2005
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA) AIR-CF3
• Scientific title: A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3)
• Date of first enrolment: August 2005
• Target sample size: 274
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00128492
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Canada, New Zealand, United States

Contacts

• Name: Bruce Montgomery, MD
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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- Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal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 Criteria:

- 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.



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: AZLI 75 mg two times a day (BID)/ three times a day (TID)

Primary Outcome(s)

Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Number of Subjects With <15% or =15% Decline in Forced Expiratory Volume in 1 Second [FEV1] From Pretreatment to 30 Minutes After Treatment With AZLI [Time Frame: Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug]

Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT) [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Serum Hematology - Mean Corpuscular Hemoglobin (MCH) [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Change in Systolic and Diastolic Blood Pressure (BP) [Time Frame: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)]

Serum Chemistry - Concentration of Total Protein [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Change in Heart Rate (HR) [Time Frame: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)]

Serum Hematology - Number of Red Blood Cells (RBC) [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Number of Participants Reporting Adverse Events (AEs) [Time Frame: Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug]

Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets [Time Frame: Baseline and end of Course 9 (Week 68)]

Change in Respiratory Rate (RR) [Time Frame: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)]

Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC) [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Serum Hematology - Mean Corpuscular Volume (MCV) [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Serum Hematology - Hemoglobin [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Change in Temperature [Time Frame: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)]

Serum Chemistry - Concentration of Chloride, Potassium, and Sodium [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Serum Hematology - Hematocrit [Time Frame: Baseline and end of treatment Course 9 (Week 68)]

Secondary Outcome(s)

Change in Body Weight [Time Frame: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)]

Missed School/Work Days Due to CF Symptoms [Time Frame: Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug]

Minimum Inhibitory Concentration (MIC) of Aztreonam [Time Frame: Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)]

Number of Participants With Other Pathogens [Time Frame: Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)]

Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75) [Time Frame: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)]

Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum [Time Frame: Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)]

Time to First Hospitalization Due to a Respiratory Event [Time Frame: Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug]

Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS) [Time Frame: Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)]

Time to Intravenous (IV) Antipseudomonal Antibiotics [Time Frame: Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug]

Secondary ID(s)

CP-AI-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/03/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00128492