Asthma
Conditions
Brief summary
Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.
Interventions
DRUGFP
ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.
DRUGLABA
LABA will be administered as per investigator discretion.
DRUGLTRA
LTRA will be administered as per investigator discretion.
DRUGLAMA
LAMA will be administered as per investigator discretion.
DRUGTheophylline
Theophylline will be administered as per investigator discretion.
Oral corticosteroids will be administered as per investigator discretion.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Asthma diagnosed by a respiratory physician greater than or equal to (\>/=) 12 months prior to study enrolment * Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1 * Documented bronchodilator response defined as \>/=12% relative improvement in FEV1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (\<) 8 milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline * Current treatment with a total daily dose of \>/= 500 micrograms (mcg) of fluticasone propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the following controller medications: long-acting Beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/Visit 1
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 prior to participant eligibility * Acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to study * 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/Visit 1 * Ex-smokers with \>/=10 pack-year smoking history * Prior treatment with bronchial thermoplasty * Participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/Visit 1 or during the study * Pregnancy prior to participation or during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin | Baseline up to Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits | Weeks 13, 26, 39, 52 |
| Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee | Baseline up to Week 52 |
| Serum Periostin Levels During the Study | Baseline, Weeks 26, 52 |
| Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels | Baseline, Weeks 26, 52 |
| Blood Eosinophil Levels During the Study | Baseline, Weeks 26, 52 |
| Serum Immunoglobulin E (IgE) Levels During the Study | Baseline, Weeks 26, 52 |
| Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations | Weeks 13, 26, 39, 52 |
| Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits | Weeks 13, 26, 39, 52 |
| Time to Treatment Failure | Baseline up to Week 52 |
| Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points | Baseline, Weeks 13, 26, 39, 52 |
| Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points | Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) |
| Change From Baseline in Asthma Control Test (ACT) at Specified Time Points | Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) |
| Percentage of Participants With Asthma Exacerbations | Baseline up to Week 52 |
| Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points | Baseline, Weeks 26, 52 |
| Time Taken for the Occurrence of First Asthma Exacerbation | Baseline up to Week 52 |
Countries
Belgium, Bulgaria, Canada, Denmark, France, Germany, Hungary, Italy, Latvia, Netherlands, Portugal, Russia, Spain, United Kingdom, United States
Outcome results
None listed