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| ID | Type | Description | Link |
|---|---|---|---|
| IWT 070709 |
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| Name | Class |
|---|---|
| Agentschap voor Innovatie door Wetenschap en Technologie | OTHER |
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The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards |
|
| placebo | Placebo Comparator | Placebo 1x/day during 5 days 3x/week afterwards |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin 250 mg | Drug | Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Severe Asthma Exacerbations | Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days. | from baseline to week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Using Rescue Medication From Baseline to Week 26 | proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used. This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guy Brusselle, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouw Ziekenhuis Aalst | Aalst | 9300 | Belgium | |||
| ZNA Middelheim |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34807989 | Derived | Undela K, Goldsmith L, Kew KM, Ferrara G. Macrolides versus placebo for chronic asthma. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD002997. doi: 10.1002/14651858.CD002997.pub5. | |
| 23291349 | Derived | Brusselle GG, Vanderstichele C, Jordens P, Deman R, Slabbynck H, Ringoet V, Verleden G, Demedts IK, Verhamme K, Delporte A, Demeyere B, Claeys G, Boelens J, Padalko E, Verschakelen J, Van Maele G, Deschepper E, Joos GF. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. Thorax. 2013 Apr;68(4):322-9. doi: 10.1136/thoraxjnl-2012-202698. Epub 2013 Jan 3. |
| Label | URL |
|---|---|
| Website of the Ghent University Hospital | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo 1x/day during 5 days 3x/week afterwards |
| FG001 | Azithromycin | Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo 1x/day during 5 days 3x/week afterwards |
| BG001 | Azithromycin | Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards |
| 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 |
| 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 | Proportion of Participants With Severe Asthma Exacerbations | Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days. | intention to treat analysis | Posted | Mean | 95% Confidence Interval | proportion of participants | from baseline to week 26 |
|
from randomisation to exit visit (during the whole study period, at least 24 weeks)
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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 | Placebo | Placebo 1x/day during 5 days 3x/week afterwards |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| deep venous trombosis | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr. Brusselle Guy | Ghent University Hospital | 003293322604 | guy.brusselle@uzgent.be |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Placebo | Drug | Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks |
|
| from baseline to week 26 |
| Peakflow Measurements | change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second | from baseline to week 26 |
| Change in Forced Expiratory Volume in 1 Second | from baseline to week 26 |
| Change in Total Score on Asthma Control Questionnaire (ACQ) | A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%) Scores range between 0 (totally controlled) and 6 (severely uncontrolled). | from baseline to week 26 |
| Change in Total Score on the Asthma-related Quality of Life (AQLQ) | A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease 32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired). Scores range 1-7, with higher scores indicating better quality of life. | from baseline to week 26 |
| Antwerp |
| 2020 |
| Belgium |
| AZ Sint-Jan Brugge | Bruges | 8000 | Belgium |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | 3000 | Belgium |
| AZ Heilig Hart Roeselare | Roeselare | 8800 | Belgium |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Proportion of Participants Using Rescue Medication From Baseline to Week 26 | proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used. This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26. | intention to treat analysis | Posted | Mean | Standard Deviation | proportion of participants | from baseline to week 26 |
|
|
|
| Secondary | Peakflow Measurements | change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second | intention to treat analysis | Posted | Mean | Standard Deviation | L/min | from baseline to week 26 |
|
|
|
| Secondary | Change in Forced Expiratory Volume in 1 Second | intention to treat analysis | Posted | Mean | Standard Deviation | percentage of baseline FEV1 | from baseline to week 26 |
|
|
|
| Secondary | Change in Total Score on Asthma Control Questionnaire (ACQ) | A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%) Scores range between 0 (totally controlled) and 6 (severely uncontrolled). | intention to treat analysis | Posted | Mean | Standard Deviation | units on a scale | from baseline to week 26 |
|
|
|
| Secondary | Change in Total Score on the Asthma-related Quality of Life (AQLQ) | A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease 32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items) 7-point Likert scale (7 = not impaired at all - 1 = severely impaired). Scores range 1-7, with higher scores indicating better quality of life. | intention to treat analysis | Posted | Mean | Standard Deviation | units on a scale | from baseline to week 26 |
|
|
|
| 4 |
| 54 |
| 39 |
| 54 |
| EG001 | Azithromycin | Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards | 7 | 55 | 37 | 55 |
| cerebrovascular accident | Blood and lymphatic system disorders | Systematic Assessment |
|
| gastro-enteritis | Gastrointestinal disorders | Systematic Assessment |
|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| acute myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| oesophagitis grade A | Gastrointestinal disorders | Systematic Assessment |
|
| pseudoparalysis right shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| vertigo | Nervous system disorders | Systematic Assessment |
|
| allergic reaction | Immune system disorders | Systematic Assessment |
|
| elevated liver function event | Hepatobiliary disorders | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| leucopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Organic Chemicals |