chronic airwayinflammation severe asthma
Conditions
Interventions
None listed
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Males and females >
Exclusion criteria
Exclusion criteria: - Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks - Acute asthma exacerbation event treated with increased doses of oral or any dose of intramuscular or intravenous corticosteroids within six weeks prior to baseline - Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline - Alcohol or substance abuse within 12 months prior to baseline - Current smoker defined as having smoked at least one cigarette (or pipe, cigar, or marijuana) per day for >=30 days within the three months prior to baseline - Ex-smokers with >=10 pack-year smoking history - Treatment with omalizumab or any anti- interleukin (IL)-4, anti-IL-5, or anti-IL-13 targeted therapy currently or within six months prior to baseline - Prior treatment with bronchial thermoplasty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The outcome measures for this study are: · Asthma exacerbation defined as: - For patients who are not on maintenance oral corticosteroid therapy: new or increased asthma symptoms (including wheeze, cough, dyspnoea, chest tightness, and/or nocturnal awakening due to these symptoms) that lead to treatment with systemic corticosteroids or to hospitalization. Treatment with systemic corticosteroids is defined as treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids for * 3 days or an emergency department visit with at least one dose of IV or IM corticosteroids. - For patients who are on maintenance oral corticosteroid therapy: new or increased asthma symptoms (including wheeze, cough, dyspnoea, chest tightness, and/or nocturnal awakening due to these symptoms) that lead to intensified treatment with systemic corticosteroids, defined as * 30 mg or 0.5 mg/kg for * 3 consecutive days, or to hospitalization. - Note: hospitalization and systemic corticosteroid treatment criteria must be verified in medical records from the treating institution. Additional details are provided in Appendix 2. · Pre-bronchodilator FEV1 · Time to first asthma exacerbation during the course of the study · TTF where treatment failure is defined as the first occurrence of one of the following events during the course of the study: - Asthma exacerbation - Clinically meaningful change in SoC asthma treatment as reported by the Investigator and confirmed by the SC · Asthma-specific health-related quality of life as assessed by MiniAQLQ overall score · Asthma-specific symptom scores, as assessed by the ACQ-7 and the ACT · SoC treatments (relevant treatments, treatment characteristics, and changes in these considered clinically meaningful by the Investigator with confirmation from the SC) · Asthma-related health care utilization defined by hospitalizations, emergency department visits, and acute care visits due to asthma and asthma-related symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety outcome measures for this study are the nature, frequency and severity of the following: · Study assessment-related AEs · SAEs: defined as any event that is fatal or life-threatening, results in unplanned hospitalization or prolongs an existing hospitalization, results in congenital anomaly/birth defect, or is deemed medically significant by the Investigator · Medical events of special interest: defined as malignancies (e.g. lymphoma); infections including respiratory infections, parasitic infections such as helminthic (e.g. schistosoma infections) and protozoan (e.g. Giardia lamblia), opportunistic infections such as histoplasmosis and coccidioidomycosis, and Listeria monocytogenes infection; newly diagnosed diabetes mellitus; cataracts; bone fractures; dental operations; anaphylaxis, anaphylactoid and hypersensitivity events; and pregnancies Exploratory Outcome Measures The exploratory outcome measures for this study are as follows: · Work and activity impairment as assessed by the WPAI-Asthma · Asthma symptoms as measured by the ASUI | — |
Countries
Netherlands
Outcome results
None listed