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The study was terminated by Sponsor due to patient recruitment challenges.
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This study will test whether daily use of azithromycin will reduce the rate of exacerbations and improve lung ventilation and perfusion assessed by XE-MRI. The sensitivity of XE-MRI to detect COPD progression will be compared with standard clinical assessment measures including standard lung function tests, 6 minute walk test, and patient reported quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A Open-label: azithromycin + SOC therapy | Experimental | Participants will receive azithromycin and SOC theraphy for 52 weeks. |
|
| Arm A Open-label: SOC therapy | Active Comparator | Participants will receive SOC theraphy for 52 weeks. |
|
| Arm B Observational: SOC therapy | Active Comparator | Participants will receive SOC theraphy for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Azithromycin will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 129Xenon (129Xe) Magnetic Resonance Imaging (MRI) Ventilation Defect Percentage (VDP) From Baseline to Week 24 | Hyperpolarized 129Xe gas was administered to the participants at specified timepoints. MRI using hyperpolarized 129Xe was used for 3D mapping of ventilation and gas distribution in the alveolar space and its uptake in interstitial barrier tissues as well as its transfer to red blood cells. Positive change from baseline indicated worse outcomes. | Baseline up to Week 24 |
| Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over 48 Weeks | A moderate COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that led to treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that led to hospitalization or death. | Baseline up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) With Severity Determined According To The World Health Organization (WHO) Toxicity Scale | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptoms, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. The WHO toxicity grading scale was used for assessing adverse event severity. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening; Grade 5: death. There were no participants with grade 5 AEs. Participants were counted once at their highest AE reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genetech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Asthma Allergy and Airway Center | Durham | North Carolina | 27705-2671 | United States | ||
| University of Virginia Health System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A Open-label: Azithromycin + SOC Therapy | Participants received azithromycin and SOC therapy for 52 weeks. |
| FG001 | Arm A Open-label: SOC Therapy | Participants received SOC therapy for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2022 |
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This is a multicenter, open-label, parallel group, randomized controlled trial (RCT).
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| HP xenon (¹²⁹XE) | Other | HP xenon (¹²⁹XE) will be administered at specified timepoints and the total dose bag volume should target 20% of the patient's forced vital capacity followed by a breath hold of up to 15 seconds |
|
| Baseline up to Week 52 |
| Change in 129Xe MRI VDP From Baseline to Week 48 | Hyperpolarized 129Xe gas was administered to the participants at specified timepoints. MRI using hyperpolarized 129Xe was used for 3D mapping of ventilation and gas distribution in the alveolar space and its uptake in interstitial barrier tissues as well as its transfer to red blood cells. Positive change from baseline indicated worse outcomes. | Baseline to Week 48 |
| Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1, Liters) From Baseline to Week 24 and Week 48 | FEV1 is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. Positive change from baseline indicated better outcomes. | Baseline to Week 24 and Week 48 |
| Charlottesville |
| Virginia |
| 22908 |
| United States |
| FG002 | Arm B Observational: SOC Therapy | Participants received SOC therapy for 52 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A Open-label: Azithromycin + SOC Therapy | Participants received azithromycin and SOC therapy for 52 weeks. |
| BG001 | Arm A Open-label: SOC Therapy | Participants received SOC therapy for 52 weeks. |
| BG002 | Arm B Observational: SOC Therapy | Participants received SOC therapy for 52 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in 129Xenon (129Xe) Magnetic Resonance Imaging (MRI) Ventilation Defect Percentage (VDP) From Baseline to Week 24 | Hyperpolarized 129Xe gas was administered to the participants at specified timepoints. MRI using hyperpolarized 129Xe was used for 3D mapping of ventilation and gas distribution in the alveolar space and its uptake in interstitial barrier tissues as well as its transfer to red blood cells. Positive change from baseline indicated worse outcomes. | ITT population. Overall number of participants analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | ventilation defect percentage | Baseline up to Week 24 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AE) With Severity Determined According To The World Health Organization (WHO) Toxicity Scale | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptoms, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. The WHO toxicity grading scale was used for assessing adverse event severity. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening; Grade 5: death. There were no participants with grade 5 AEs. Participants were counted once at their highest AE reported. | Safety population | Posted | Number | Number of Participants | Baseline up to Week 52 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in 129Xe MRI VDP From Baseline to Week 48 | Hyperpolarized 129Xe gas was administered to the participants at specified timepoints. MRI using hyperpolarized 129Xe was used for 3D mapping of ventilation and gas distribution in the alveolar space and its uptake in interstitial barrier tissues as well as its transfer to red blood cells. Positive change from baseline indicated worse outcomes. | ITT Population. Overall number analyzed is the number of participants with data available for analyses. | Posted | Mean | Standard Deviation | ventilation defect percentage | Baseline to Week 48 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1, Liters) From Baseline to Week 24 and Week 48 | FEV1 is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. Positive change from baseline indicated better outcomes. | ITT Population. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints. | Posted | Mean | Standard Deviation | liters | Baseline to Week 24 and Week 48 |
|
| ||||||||||||||||||||||||||||||||
| Primary | Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over 48 Weeks | A moderate COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that led to treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation was defined as new or increased COPD symptoms (e.g., dyspnea, sputum volume, and sputum purulence) for at least 2 consecutive days that led to hospitalization or death. | ITT population | Posted | Mean | Standard Deviation | exacerbations per year | Baseline up to Week 48 |
|
|
Baseline up to Week 48
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A - SOC + Azithromycin | Participants received azithromycin and SOC theraphy for 52 weeks. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Cohort A - SOC | Participants received SOC theraphy for 52 weeks | 0 | 5 | 2 | 5 | 5 | 5 |
| EG002 | Cohort B - SOC | Participants received SOC theraphy for 52 weeks. | 0 | 4 | 2 | 4 | 2 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory syncytial virus infection | Infections and infestations | Medra 26.0 | Non-systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | Medra 26.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | Medra 26.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Medra 26.0 | Non-systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | Medra 26.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | Medra 26.0 | Non-systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | Medra 26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | Medra 26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | Medra 26.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | Medra 26.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra 26.0 | Non-systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Medra 26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | Medra 26.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Medra 26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Medra 26.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Medra 26.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Medra 26.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | Medra 26.0 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Jun 18, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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| Counts |
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| Participants |
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