N/A
N=64
Comparison of Biologicals in Treatment of Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT04158050 ↗Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Dec 2023
Primary outcome: Primary: Change in Number of Exacerbations of the Participants — 2.77; 1.32 Change in number of courses of oral c
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- IL5 Antagonist or anti-IL5R-antibody or Omalizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Helsinki University Central Hospital
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Exacerbations of the Participants |
2.77; 1.32 | — |
| SECONDARY Change in Oral Corticosteroid Dose in Milligrams |
3.0; 2.29 | — |
| SECONDARY Change in the Number of Courses of Antimicrobics |
0.69; 0.23 | — |
| SECONDARY Change in the Number of Emergency Room Visits of the Participants |
0.29; 0.18 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- asthma that remains uncontrolled despite moderate to high dose inhaled corticosteroid and additional therapy with at least one other controller medication and need for continuous per oral corticosteroids (OCS) or contraindications (or clinically significant side effects of OCS) against OCS and/or frequent courses (two or more per year) of OCS
Exclusion Criteria
- patients without asthma
Data sourced from ClinicalTrials.gov (NCT04158050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.