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The purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.
Community-acquired respiratory viral (CARV) infections after lung transplantation are associated with an increased risk for the development of chronic lung allograft dysfunction (CLAD) after lung transplantation. The exact mechanisms whereby CARV infections increase this risk are unknown. We propose that viral infection results in airway epithelial cell injury and the expression of injury-response genes that provide signals that initiate immunologic and non-immunologic pathways that result in the airway remodeling characteristic of obliterative bronchiolitis, the predominant pathology of CLAD. Systemic and inhaled corticosteroids are frequently used as anti-inflammatory agents to treat the peribronchiolar inflammation seen in viral bronchiolitis. Beneficial effects from corticosteroids have been reported, but this has not been demonstrated in lung transplant recipients. The aim of this single center, randomized, double blind, placebo controlled study is to evaluate the short and long term effects of a 6 month course of inhaled beclomethasone on adult lung transplant recipients with CARV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled beclomethasone | Experimental | Inhaled beclomethasone 320 mcg twice daily for 180 days. |
|
| Placebo | Placebo Comparator | Inhaled placebo twice daily for 180 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled beclomethasone | Drug | Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction | 180 days | |
| Death | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Rejection | 180 days | |
| Lymphocytic Bronchiolitis | 180 days | |
| Donor-specific Antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramsey Hachem, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
There is no plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Beclomethasone | Inhaled beclomethasone 320 mcg twice daily for 180 days. Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection |
| FG001 | Placebo | Inhaled placebo twice daily for 180 days. Placebo: Placebo will serve as a control treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Beclomethasone | Inhaled beclomethasone 320 mcg twice daily for 180 days. Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction | Posted | Count of Participants | Participants | 180 days |
|
|
180 days
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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 | Inhaled Beclomethasone | Inhaled beclomethasone 320 mcg twice daily for 180 days. Inhaled beclomethasone: Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Lung Allograft Dysfunction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New Respiratory Viral Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramsey Hachem, MD | Washington University in St. Louis | 3144548766 | rhachem@wustl.edu |
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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 | May 28, 2015 | Jan 17, 2022 | Prot_SAP_000.pdf |
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| Placebo | Drug | Placebo will serve as a control treatment |
|
| 180 days |
| Chronic Lung Allograft Dysfunction | 180 days |
Inhaled placebo twice daily for 180 days.
Placebo: Placebo will serve as a control treatment
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Bronchiolitis Obliterans Syndrome Stage | Number | participants |
|
| Participants |
|
|
| Primary | Death | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Acute Rejection | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Lymphocytic Bronchiolitis | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Donor-specific Antibodies | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Secondary | Chronic Lung Allograft Dysfunction | Posted | Count of Participants | Participants | 180 days |
|
|
|
| 0 |
| 7 |
| 3 |
| 7 |
| 7 |
| 7 |
| EG001 | Placebo | Inhaled placebo twice daily for 180 days. Placebo: Placebo will serve as a control treatment | 0 | 8 | 5 | 8 | 8 | 8 |
| New Respiratory Viral Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lower Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cold Symptoms | General disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Hoarseness | General disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Skin Cancer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic Lung Allograft Dysfunction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
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| Mycobacterial Infection | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | Systematic Assessment |
|
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