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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00128492
Registration number
NCT00128492
Ethics application status
Date submitted
8/08/2005
Date registered
10/08/2005
Date last updated
19/05/2011
Titles & IDs
Public title
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
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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)
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Secondary ID [1]
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CP-AI-006
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Universal Trial Number (UTN)
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Trial acronym
AIR-CF3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZLI 75 mg two times a day (BID)/ three times a day (TID)
Treatment: Drugs: AZLI 75 mg two times a day (BID)/ three times a day (TID)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Reporting Adverse Events (AEs)
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Assessment method [1]
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Participants experiencing at least 1 treatment-emergent AE or at least 1 serious adverse event (SAE) were summarized for the study as a whole. A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in hospitalization or death.
Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals throughout the 18-month study period.
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Timepoint [1]
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Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug
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Primary outcome [2]
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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
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Assessment method [2]
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Airway reactivity (percent change in FEV1 from pretreatment to 30 minutes after treatment with AZLI) was assessed at all study visits in which a participant received AZLI treatment. A participant was included in this endpoint if they experienced a decline in FEV1 of =15% at any visit in which they received AZLI.
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Timepoint [2]
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Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug
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Primary outcome [3]
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Change in Heart Rate (HR)
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Assessment method [3]
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HR was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
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Timepoint [3]
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Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)
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Primary outcome [4]
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Change in Systolic and Diastolic Blood Pressure (BP)
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Assessment method [4]
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BP was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
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Timepoint [4]
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Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)
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Primary outcome [5]
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Change in Temperature
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Assessment method [5]
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Temperature was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
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Timepoint [5]
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Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)
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Primary outcome [6]
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Change in Respiratory Rate (RR)
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Assessment method [6]
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RR was recorded at all visits.
Change from baseline at the end of AZLI treatment Courses 1 (Visit 2), 3 (Visit 4), and 9 (Visit 19) was determined.
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Timepoint [6]
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Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68)
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Primary outcome [7]
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Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets
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Assessment method [7]
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Timepoint [7]
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Baseline and end of Course 9 (Week 68)
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Primary outcome [8]
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Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils
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Assessment method [8]
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Timepoint [8]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [9]
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Serum Hematology - Number of Red Blood Cells (RBC)
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Assessment method [9]
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Timepoint [9]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [10]
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Serum Hematology - Hematocrit
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Assessment method [10]
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Timepoint [10]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [11]
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Serum Hematology - Hemoglobin
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Assessment method [11]
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Timepoint [11]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [12]
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Serum Hematology - Mean Corpuscular Volume (MCV)
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Assessment method [12]
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Timepoint [12]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [13]
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Serum Hematology - Mean Corpuscular Hemoglobin (MCH)
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Assessment method [13]
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Timepoint [13]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [14]
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Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC)
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Assessment method [14]
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Timepoint [14]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [15]
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Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT)
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Assessment method [15]
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Timepoint [15]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [16]
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Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen
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Assessment method [16]
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Timepoint [16]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [17]
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Serum Chemistry - Concentration of Chloride, Potassium, and Sodium
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Assessment method [17]
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Timepoint [17]
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Baseline and end of treatment Course 9 (Week 68)
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Primary outcome [18]
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Serum Chemistry - Concentration of Total Protein
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Assessment method [18]
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Timepoint [18]
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Baseline and end of treatment Course 9 (Week 68)
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Secondary outcome [1]
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Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum
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Assessment method [1]
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Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype).
Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.
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Timepoint [1]
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Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)
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Secondary outcome [2]
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Number of Participants With Other Pathogens
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Assessment method [2]
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Sputum samples were collected at all study visits for qualitative and quantitative culture for Burkholderia cepacia complex (BCC), Stenotrophomonas maltophilia, Achromobacter xylosoxidans, Staphylococcus aureus (including methicillin-sensitive [MSSA] and methicillin-resistant [MRSA] S.aureus), and fungal organisms.
Number of participants with other pathogens at baseline and end of AZLI treatment Courses 1, 3, and 9 are reported.
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Timepoint [2]
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Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)
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Secondary outcome [3]
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Minimum Inhibitory Concentration (MIC) of Aztreonam
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Assessment method [3]
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The aztreonam susceptibility of PA isolates from expectorated sputum samples (collected at all visits) was assessed.
MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).
MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).
MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.
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Timepoint [3]
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Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72)
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Secondary outcome [4]
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Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75)
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Assessment method [4]
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Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines.
FEV1 = the volume of air exhaled in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudson equation, based upon participant age, gender, and height. FVC = (forced vital capacity) the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC.
The percent change from baseline is presented for each endpoint.
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Timepoint [4]
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Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)
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Secondary outcome [5]
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Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS)
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Assessment method [5]
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The CFQ-R was administered at baseline and every visit thereafter. The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores: 0-100; higher scores indicate fewer symptoms). The minimal clinically important difference (MCID) corresponds to the smallest change in symptoms that a patient can detect and is a change in score of 4 points.
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Timepoint [5]
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Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)
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Secondary outcome [6]
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Time to First Hospitalization Due to a Respiratory Event
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Assessment method [6]
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Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) electronic case report form (eCRF).
Time to first hospitalization was the number of days from baseline (Visit 1) to the date of first hospitalization or the date of study completion (last visit) /or early withdrawal if censored.
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Timepoint [6]
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Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug
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Secondary outcome [7]
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Change in Body Weight
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Assessment method [7]
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Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated.
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Timepoint [7]
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Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68)
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Secondary outcome [8]
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Missed School/Work Days Due to CF Symptoms
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Assessment method [8]
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Participants were provided with a diary card at each visit to record days of work and/or school missed due to their CF symptoms.
The percentage of school/work days missed was calculated as the total number of school/work days missed divided by the total number of on-study days multiplied by 100 across all participants in a treatment group.
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Timepoint [8]
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Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug
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Secondary outcome [9]
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Time to Intravenous (IV) Antipseudomonal Antibiotics
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Assessment method [9]
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Use of IV antipseudomonal antibiotics was compiled from data recorded on the Concomitant Medications eCRF. The time to first IV antipseudomonal antibiotic use was the number of days from baseline (Visit 1) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit) /or early withdrawal if censored.
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Timepoint [9]
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Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug
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Eligibility
Key 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.
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2009
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Sample size
Target
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Accrual to date
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Final
274
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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- Westmead
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Recruitment hospital [2]
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- Herston
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Recruitment hospital [3]
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- Adelaide
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Recruitment hospital [4]
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- Prahan
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Recruitment hospital [5]
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- Nedlands
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Recruitment hospital [6]
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- Perth
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment postcode(s) [2]
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- Herston
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Prahan
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Recruitment postcode(s) [5]
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- Nedlands
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Recruitment postcode(s) [6]
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- Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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Alaska
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United States of America
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State/province [3]
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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State/province [6]
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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State/province [9]
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Georgia
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United States of America
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Illinois
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United States of America
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State/province [11]
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Indiana
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Country [12]
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United States of America
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State/province [12]
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Kansas
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Country [13]
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United States of America
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State/province [13]
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Louisiana
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Country [14]
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United States of America
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State/province [14]
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Massachusetts
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Country [15]
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United States of America
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State/province [15]
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Michigan
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United States of America
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State/province [16]
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Minnesota
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United States of America
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Missouri
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Country [18]
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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Canada
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Alberta
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Canada
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State/province [32]
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Ontario
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Country [33]
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New Zealand
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State/province [33]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00128492
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bruce Montgomery, MD
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Address
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Gilead Sciences
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00128492
Download to PDF
Show all queries