| Primary | Number of Participants Reporting Adverse Events (AEs) | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Number | | participants | | Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| | | Title | Denominators | Categories |
|---|
| Number of Participants Reporting at Least One AE | | | | Participants Reporting at least One Related AE | | |
| |
| 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 | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Number | | Participants | | Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Change in Heart Rate (HR) | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | beats/minute | | Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Change in Systolic and Diastolic Blood Pressure (BP) | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Secondary | Change From Baseline in Pseudomonas Aeruginosa (PA) log10 Colony-forming Units (CFU) Per Gram of Sputum | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | Log10 PA CFUs/g | | Baseline, and the end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
|
| Secondary | Number of Participants With Other Pathogens | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Number | | Participants | | Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Secondary | Minimum Inhibitory Concentration (MIC) of Aztreonam | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Number | | µg/mL | | Baseline; end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68); and at Follow-up (Week 72) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Secondary | Percent Change in Pulmonary Function (FEV1, FEV1 Percent Predicted, FVC, FEF25-75) | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | Percent change from baseline | | Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
|
| Secondary | Change in Clinical Symptoms as Assessed by the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Scale (CFQ-R RSS) | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Secondary | Time to First Hospitalization Due to a Respiratory Event | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Median | Full Range | Days | | Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Secondary | Change in Body Weight | Weight was measured at all visits and was reported to the nearest 0.1 kg/lb. Percent change in weight from baseline was calculated. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Error | Percent change from baseline | | Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20), and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Secondary | Missed School/Work Days Due to CF Symptoms | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | Percentage of days missed | | Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Secondary | Time to Intravenous (IV) Antipseudomonal Antibiotics | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Median | 95% Confidence Interval | Days | | Overall study (72 weeks) included nine 28-day courses of study drug alternating with nine 28-day courses off drug | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Change in Temperature | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | degrees Celsius | | Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Change in Respiratory Rate (RR) | 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. | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | breaths/minute | | Baseline, and end of treatment Courses 1 (Week 4), 3 (Week 20) and 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Concentration of White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, and Platelets | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. Results obtained at the end of a 28-day treatment period are presented for selected timepoints. | Posted | | Mean | Standard Deviation | number of cells x10^3/µL | | Baseline and end of Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Percent of Differential for Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | percent of differential | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Number of Red Blood Cells (RBC) | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | number x10^6/µL | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Hematocrit | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | percent | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Hemoglobin | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Mean Corpuscular Volume (MCV) | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | fL | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Mean Corpuscular Hemoglobin (MCH) | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | pg | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Hematology - Mean Corpuscular Hemoglobin Concentration (MCHC) | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Chemistry - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-glutamlytransferase (GGT) | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | U/L | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Chemistry - Concentration of Calcium, Creatinine, Direct Bilirubin, Total Bilirubin, Serum Glucose, and Blood Urea Nitrogen | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Chemistry - Concentration of Chloride, Potassium, and Sodium | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | mEq/L | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |
| Primary | Serum Chemistry - Concentration of Total Protein | | The analysis population consisted of all enrolled participants who received one or more doses of AZLI. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and end of treatment Course 9 (Week 68) | | | | ID | Title | Description |
|---|
| OG000 | 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | | OG001 | 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily |
| |