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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004420-11 | EudraCT Number | ||
| IWT-TBM 130233 | Other Grant/Funding Number | Agentschap voor Innovatie door Wetenschap en Technologie |
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slow recruitment
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| Name | Class |
|---|---|
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
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This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission. Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment and by restricting the treatment to acute periods with highest risk for treatment failure, benefits may counterbalance potential side effects, which may result in a new treatment strategy for these acute events.
The present study is designed by the services of respiratory medicine of the Leuven and Ghent University hospitals but will run in total in 17 different large hospitals in Belgium, of which 12 are located in Flanders.
In this 9 month, randomized, placebo-controlled, parallel-group, multicenter intervention trial, 500 patients will be randomly assigned (1:1 ratio) to receive either azithromycin or placebo on top of standard therapy in the acute treatment of COPD exacerbations requiring hospitalization. The study drug (azithromycin or placebo) will be initiated and uploaded within 48 hours after hospital admission (500mg once a day for 3 days) and subsequently administered for a prolonged period of 3 months at a lower maintenance dose (250mg every 2 days). An additional follow-up period of 6 months without study drug will be foreseen to study relapse after study drug withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | N = 250
|
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| Placebo | Placebo Comparator | N = 250
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical failure | Clinical failure is a composite endpoint as multiple clinical interventions may indicate that an initiated therapy is failing. Clinical failure is defined as the composite of death, treatment intensification (additional dose of systemic steroids, switch antibiotics for respiratory reasons or new course of systemic steroids and/or antibiotics) and step up in hospital care for respiratory reasons (from ward to ICU during index event, or from home to ward or ICU (new admission) after discharge). Primary outcome measure will also be analysed in following subgroups as an exploratory analysis:
| Will be assessed between day 1 (from 1 hour after first drug intake) till day 90 (24 hours after last study drug intake) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinical failures up to Day 90 (key secondary #1) | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wim Janssens, MD. PhD | KU Leuven - UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Brussel Hoofdstedelijk Gewest | 1090 | Belgium | ||
| St. Pieterziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31665017 | Derived | Vermeersch K, Belmans A, Bogaerts K, Gyselinck I, Cardinaels N, Gabrovska M, Aumann J, Demedts IK, Corhay JL, Marchand E, Slabbynck H, Haenebalcke C, Vermeersch S, Verleden GM, Troosters T, Ninane V, Brusselle GG, Janssens W; BACE trial investigators. Treatment failure and hospital readmissions in severe COPD exacerbations treated with azithromycin versus placebo - a post-hoc analysis of the BACE randomized controlled trial. Respir Res. 2019 Oct 29;20(1):237. doi: 10.1186/s12931-019-1208-6. | |
| 27099485 |
| Label | URL |
|---|---|
| Protocol paper | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Not provided
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 20, 2019 | |
| Reset | Dec 9, 2019 | |
| Release | Apr 7, 2020 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2016 | Dec 8, 2017 |
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| Placebo | Drug |
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|
|
| Will be assessed on day 90 (last day of treatment phase) |
| COPD Assessment Test (CAT) score at Day 90 (key secondary #2) | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) |
| Total days of additional/prolonged systemic steroid use at Day 90 (key secondary #3) | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) |
| Number of clinical failures up to Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 270 (last day of follow-up phase) |
| Time to clinical failure up to Day 90 and up to Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Time to new exacerbation within 90 and within 270 days | A new exacerbation is defined as the composite of new course of systemic steroids and/or antibiotics, and hospitalization for respiratory reasons, all after the index event. Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Number of new exacerbations up to 90 days and up to 270 days | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Total days of hospital days within 90 and within 270 days | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Total days in intensive care within 90 and within 270 days | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Quality of Life - 5 Dimensions (EQ5D) score at Day 90 and at Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| COPD Assessment Test (CAT) score at Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 270 (last day of follow-up phase) |
| Modified Medical Research Council (mMRC) score at Day 90 and Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Speech, Spatial and Qualities of Hearing (SSQ5) score at Day 90 and Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Day 90 and Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Total dose of additional/prolonged systemic steroids at Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 270 (last day of follow-up phase) |
| Total days of additional/prolonged systemic steroid use at Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 270 (last day of follow-up phase) |
| Total days of non-study antibiotic use at Day 90 and Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Number of home physician contacts at Day 90 and Day 270 | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Average cost of hospitalization at Day 90 and Day 270 including the index hospitalization | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Time to death within 90 and within 270 days | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Time to first treatment intensification within 90 and within 270 days | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Time to first step up in hospital care for respiratory reasons within 90 and within 270 days | Secondary outcome measure will also be analysed in following subgroups as exploratory analysis:
| Will be assessed on day 90 (last day of treatment phase) and day 270 (last day of follow-up phase) |
| Brussels |
| Brussels Capital |
| 1000 |
| Belgium |
| ZNA Middelheim | Antwerp | Flanders | 2020 | Belgium |
| St. Augustinus Ziekenhuis | Antwerp | Flanders | 2610 | Belgium |
| Imelda Ziekenhuis | Bonheiden | Flanders | 2820 | Belgium |
| St. Jan Brugge Ziekenhuis | Bruges | Flanders | 8000 | Belgium |
| Maria Middelaresziekenhuis | Ghent | Flanders | 9000 | Belgium |
| UZ Gent | Ghent | Flanders | 9000 | Belgium |
| Jessa Ziekenhuis | Hasselt | Flanders | 3500 | Belgium |
| AZ Groeninge Ziekenhuis | Kortrijk | Flanders | 8500 | Belgium |
| UZ Gasthuisberg | Leuven | Flanders | 3000 | Belgium |
| Heilig Hart Ziekenhuis | Roeselare | Flanders | 8800 | Belgium |
| St. Andriesziekenhuis | Tielt | Flanders | 8700 | Belgium |
| CHU Charleroi | Charleroi | Wallonia | 6110 | Belgium |
| Grand Hôpital de Charleroi | Gilly | Wallonia | 6060 | Belgium |
| CHU Liège | Liège | Wallonia | 4000 | Belgium |
| CHU Mont-Godinne | Yvoir | Wallonia | 5530 | Belgium |
| Onze-Lieve-Vrouwziekenhuis | Aalst | 9300 | Belgium |
| Clinique Reine Astrid | Malmedy | 4960 | Belgium |
| Clinique Sainte-Elisabeth | Namur | 5000 | Belgium |
| Derived |
| Vermeersch K, Gabrovska M, Deslypere G, Demedts IK, Slabbynck H, Aumann J, Ninane V, Verleden GM, Troosters T, Bogaerts K, Brusselle GG, Janssens W. The Belgian trial with azithromycin for acute COPD exacerbations requiring hospitalization: an investigator-initiated study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Mar 31;11:687-96. doi: 10.2147/COPD.S95501. eCollection 2016. |
| Statistical Analysis Plan | View IPD |
| Reset | Apr 17, 2020 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2017 | Dec 11, 2017 | SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 20, 2019 | Dec 9, 2019 | |||
| Apr 7, 2020 | Apr 17, 2020 |
| 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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