Phase 3
N=274
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00128492 ↗Enrolled (actual)
274
Serious AEs
50.4%
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants Reporting Adverse Events (AEs) — 83; 185; 30; 79 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AZLI 75 mg two times a day (BID)/ three times a day (TID) (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Adverse Events (AEs) |
83; 185; 30; 79; 38; 100 | — |
| PRIMARY 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 |
76; 175; 9; 14 | — |
| PRIMARY Change in Heart Rate (HR) |
1.08; -0.07; -0.53; 0.13; 3.87; -0.06 | — |
| PRIMARY Change in Systolic and Diastolic Blood Pressure (BP) |
0.75; 1.19; -0.67; 0.29; -1.06; -0.33 | — |
| PRIMARY Change in Temperature |
-0.05; 0.00; -0.09; 0.01; 0.04; 0.05 | — |
| PRIMARY Change in Respiratory Rate (RR) |
-0.07; 0.17; -0.03; 0.02; 0.02; 0.33 | — |
| PRIMARY Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets |
9.28; 10.11; 9.47; 9.53; 0.05; 0.06 | — |
| PRIMARY Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils |
0.59; 0.61; 0.59; 0.62; 2.05; 1.95 | — |
| PRIMARY Serum Hematology - Number of Red Blood Cells (RBC) |
5.15; 4.94; 4.93; 4.77 | — |
| PRIMARY Serum Hematology - Hematocrit |
43.43; 42.45; 42.00; 41.63 | — |
| PRIMARY Serum Hematology - Hemoglobin |
14.06; 13.70; 13.89; 13.71 | — |
| PRIMARY Serum Hematology - Mean Corpuscular Volume (MCV) |
84.33; 86.08; 85.38; 87.72 | — |
| PRIMARY Serum Hematology - Mean Corpuscular Hemoglobin (MCH) |
27.43; 27.84; 28.35; 28.89 | — |
| PRIMARY Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC) |
32.41; 32.34; 33.13; 32.99 | — |
| PRIMARY Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT) |
31.21; 26.65; 30.78; 27.81; 27.83; 25.77 | — |
| PRIMARY Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen |
9.67; 9.56; 9.43; 9.47; 0.80; 0.81 | — |
| PRIMARY Serum Chemistry - Concentration of Chloride, Potassium, and Sodium |
102.17; 102.22; 101.81; 102.16; 4.20; 4.29 | — |
| PRIMARY Serum Chemistry - Concentration of Total Protein |
7.63; 7.58; 7.47; 7.53 | — |
| SECONDARY Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum |
-0.20; -0.81; -0.43; -0.53; -0.47; -0.60 | — |
| SECONDARY Number of Participants With Other Pathogens |
33; 65; 34; 66; 41; 68 | — |
| SECONDARY Minimum Inhibitory Concentration (MIC) of Aztreonam |
4; 4; 4; 8; 8; 8 | — |
| SECONDARY Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75) |
4.87; 7.98; 3.55; 6.04; 1.31; 3.98 | — |
| SECONDARY Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS) |
3.53; 6.83; 0.37; 7.34; 0.30; 6.01 | — |
| SECONDARY Time to First Hospitalization Due to a Respiratory Event |
359; 417 | — |
| SECONDARY Change in Body Weight |
0.58; 0.85; 1.31; 1.38; 3.24; 3.55 | — |
| SECONDARY Missed School/Work Days Due to CF Symptoms |
2.00; 3.19 | — |
| SECONDARY Time to Intravenous (IV) Antipseudomonal Antibiotics |
276; 232 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00128492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.