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| Name | Class |
|---|---|
| Ida Montini Foundation | OTHER |
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This is a retrospective clinical study on adult patients (18 years or more) with biological therapy for severe asthma at the Helsinki University Central Hospital (HUCH). This is a real-life study with a broader patient population than in a randomized controlled trial. Omalizumab has been used for treatment of asthma in HUCH since January 2009, anti-IL5 therapies starting with mepolizumab since April 2016.
The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-IL5/IL5R-therapy group | Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R |
| |
| anti-IgE-therapy group | Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL5 Antagonist or anti-IL5R-antibody or Omalizumab | Drug | mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Exacerbations of the Participants | Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids. | baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oral Corticosteroid Dose in Milligrams | Change in oral corticosteroid dose in milligrams | The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy" |
| Change in the Number of Courses of Antimicrobics |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Polypectomy, FESS and Ethmoidectomy | Change in number of Polypectomy, FESS and ethmoidectomy | The baseline (before biologicals) and the latest 12 months after initiation of biologicals |
Inclusion Criteria:
Exclusion Criteria:
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Asthma patients that have received biologicals (anti-IL5/IL5R or anti-IgE) for asthma with or without chronic rhinitis and nasal polyps.
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| Name | Affiliation | Role |
|---|---|---|
| Paula Kauppi, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32467765 | Derived | Kotisalmi E, Hakulinen A, Makela M, Toppila-Salmi S, Kauppi P. A comparison of biologicals in the treatment of adults with severe asthma - real-life experiences. Asthma Res Pract. 2020 May 13;6:2. doi: 10.1186/s40733-020-00055-9. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-IL5/IL5R-therapy Group | Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma |
| FG001 | Anti-IgE-therapy Group | Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-IL5/IL5R-therapy Group | Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma |
| BG001 | Anti-IgE-therapy Group |
| 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 | Change in Number of Exacerbations of the Participants | Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids. | Posted | Mean | Standard Deviation | Change in number of courses of oral c | baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals) |
|
Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3).
Adverse events information was collected in the medical records.
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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 | Anti-IL5/IL5R-therapy Group | Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumopleuritis and pericarditis | Cardiac disorders | Non-systematic Assessment | Pneumopleuritis and pericarditis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Paula Kauppi | Helsinki University Hospital | +358504286802 | paula.kauppi@hus.fi |
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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 | Sep 4, 2019 | Feb 28, 2023 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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Change in the number of courses of antimicrobics |
| The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals |
| Change in the Number of Emergency Room Visits of the Participants | Change in the number of emergency room visits of the participants | The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals |
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Change in Oral Corticosteroid Dose in Milligrams | Change in oral corticosteroid dose in milligrams | Posted | Mean | Standard Deviation | Milligrams | The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy" |
|
|
|
| Secondary | Change in the Number of Courses of Antimicrobics | Change in the number of courses of antimicrobics | Posted | Mean | Standard Deviation | Change in antimicrobial courses/year | The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals |
|
|
|
| Secondary | Change in the Number of Emergency Room Visits of the Participants | Change in the number of emergency room visits of the participants | Posted | Mean | Standard Deviation | Change in number of emergency visits | The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals |
|
|
|
| Other Pre-specified | Change in Number of Polypectomy, FESS and Ethmoidectomy | Change in number of Polypectomy, FESS and ethmoidectomy | Posted | Mean | Standard Deviation | Procedures | The baseline (before biologicals) and the latest 12 months after initiation of biologicals |
|
|
|
| 0 |
| 42 |
| 1 |
| 42 |
| 7 |
| 42 |
| EG001 | Anti-IgE-therapy Group | Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma | 0 | 22 | 0 | 22 | 4 | 22 |
|
| Fatique | Nervous system disorders | Non-systematic Assessment |
|
| Fever | Immune system disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rise in transaminases | Gastrointestinal disorders | Non-systematic Assessment |
|
| Limb or joint pain or oedema | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lip swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Ethmoidectomy |
|