| Primary | Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry | Within-subject change to absolute FEV1 month 1 vs. 0. FEV1 was measured 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). | | Posted | | Median | Inter-Quartile Range | Liter | | Baseline, month 1 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.04(-0.22 to 0.12)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | t-test, 2 sided | | 0.2030 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | |
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| Primary | Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry | Within-subject change to absolute FEV1 month 5 vs 0. | | Posted | | Median | Inter-Quartile Range | Liter | | Baseline, month 5 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Secondary | Change in FEV1 Off AZLI Therapy | This will be compared to study month 0 (baseline, when obtained as standard of care (SOC). | Partial data for this outcome measure was collected on 4 participants and due to not having complete data set analyzation was not completed. | Posted | | | | | | At Study Months 2 and 4 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Secondary | Change in HRQOL Off AZLI Therapy. | This will be compared to study month 0 (baseline), when obtained at standard of care visit (SOC) | Partial data for this outcome measure was collected on 4 participants and due to not having a complete data set the analyzation was not completed. | Posted | | | | | | At study months 2 or 4 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Secondary | Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid. | Microbiology data was collected when performed for SOC purposes on BAL or sputum samples. Baseline and 1 month value represents the culture final report value (0,1+, 2+, 3+, 4+) of Pseudomonas aeruginosa. A value of zero represents no Pseudomonas aeruginosa sputum or bronchoalveolar fluid. A value of 4 represents high amounts of Pseudomonas aeruginosa sputum or bronchoalveolar fluid. | The statistical analysis was unable to be performed due to insufficient number of paired observations. Only 9 of 30 enrolled had baseline microbiology data, 3 were cultured positive for Pseudomonas Aeruginosa. Only 1 of the 3 had a subsequent SOC BAL sample collected. Therefore, only raw data is entered for the one subject. | Posted | | Number | | culture value of Pseudomonas aeruginosa | | Baseline, month 1 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Secondary | Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC). | The study team is measuring the change in neutrophils AFTER treatment. They will compare a SOC BAL taken after AZLI with the BAL taken within 90 days of AZLI initiation (pre or baseline measure). The post AZLI BAL measurement time range is 15 days after first course of AZLI up to last day of the 3rd and final course of AZLI (over a period of 5 consecutive months). | Participants with paired SOC bronchoalveolar lavage fluid cell differential counts performed within 90 days of AZLI month 1 (baseline timepoint) and >=15 days after AZLI dose 1 through the completion of dose 3 (study month 5) were included in the analysis (n=5). | Posted | | Mean | Standard Deviation | mean percentage of neutrophils | | Baseline - defined as a within 90 days of enrollment and After Treatment (5 months) | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Primary | Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 | The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 1 vs. 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). | subjects with completed SF-36 surveys at month 1 and month 0 (n=28) | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline, month 1 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Primary | Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5. | The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 5 vs 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 and 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). | subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points. | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline, month 5 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Primary | Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 | The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 1 vs. 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in the Total Score. The SGRQ was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). | subjects with completed SF-36 surveys at month 1 and month 0 (n=28) time-points. | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline, month 1 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Primary | Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5. | The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 5 vs 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in theTotal Score. The SGRQ was completed 14-35 days after the start of month 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose). | subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points. | Posted | | Median | Inter-Quartile Range | units on a scale | | Baseline, month 5 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Primary | Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5. | Within-subject change to absolute FEF 25-75 month 5 vs 0. FEF 25-75 was measured 14-35 days after the start of months 5 | | Posted | | Median | Inter-Quartile Range | Liter | | Baseline, month 5 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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| Primary | Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 | Within-subject change to absolute FEF 25-75 month 1 vs. 0. FEF 25-75 was measured 14-35 days after the start of months 1 | | Posted | | Median | Inter-Quartile Range | Liter | | Baseline, month 1 | | | | ID | Title | Description |
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| OG000 | Aztreonam Lysine for Inhalation (AZLI) | Patients to received Aztreonam Lysine(AZLI) Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI) Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care. |
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