NCT04158050: BiSA

Comparison of Biologicals in Treatment of Severe Asthma

Completed Results posted Last updated 4 December 2023

What this trial tests

trial testing IL5 Antagonist or anti-IL5R-antibody or Omalizumab in Asthma in 64 participants. Completed in 31 October 2020.

Timeline

1 January 2018

Primary endpoint
31 October 2020

31 October 2020

Quick facts

Lead sponsor	Helsinki University Central Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	64
Start date	1 January 2018
Primary completion	31 October 2020
Estimated completion	31 October 2020
Sites	1 location across Finland

Drugs / interventions tested

• IL5 Antagonist or anti-IL5R-antibody or Omalizumab — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Helsinki University Central Hospital

Who can join

18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Number of Exacerbations of the Participants Primary · baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)

Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.

Group	Value	95% CI
Anti-IL5/IL5R-therapy Group	2.77	± 7.91
Anti-IgE-therapy Group	1.32	± 2.01

Change in Oral Corticosteroid Dose in Milligrams Secondary · 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 oral corticosteroid dose in milligrams

Group	Value	95% CI
Anti-IL5/IL5R-therapy Group	3.0	± 7.91
Anti-IgE-therapy Group	2.29	± 5.80

Change in the Number of Courses of Antimicrobics Secondary · The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals

Change in the number of courses of antimicrobics

Group	Value	95% CI
Anti-IL5/IL5R-therapy Group	0.69	± 2.08
Anti-IgE-therapy Group	0.23	± 1.47

Change in the Number of Emergency Room Visits of the Participants Secondary · 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

Group	Value	95% CI
Anti-IL5/IL5R-therapy Group	0.29	± 1.30
Anti-IgE-therapy Group	0.18	± 1.19

Change in Number of Polypectomy, FESS and Ethmoidectomy Secondary · The baseline (before biologicals) and the latest 12 months after initiation of biologicals

Change in number of Polypectomy, FESS and ethmoidectomy

Polypectomy

Group	Value	95% CI
Anti-IL5/IL5R-therapy Group	1.24	± 3.03
Anti-IgE-therapy Group	1.41	± 4.69

FESS

Group	Value	95% CI
Anti-IL5/IL5R-therapy Group	0.95	± 0.89
Anti-IgE-therapy Group	0.82	± 1.25

Ethmoidectomy

Group	Value	95% CI
Anti-IL5/IL5R-therapy Group	0.71	± 0.94
Anti-IgE-therapy Group	0.12	± 0.68

Adverse events — posted to ClinicalTrials.gov

Time frame: 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).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Anti-IL5/IL5R-therapy Group

Serious: 1/42 (2%)

Deaths: 0/42

Anti-IgE-therapy Group

Serious: 0/22 (0%)

Deaths: 0/22

Serious adverse events (1 terms)

Reaction	System	Anti-IL5/IL5R-therapy Group	Anti-IgE-therapy Group
Pneumopleuritis and pericarditis	Cardiac disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Anti-IL5/IL5R-therapy Group	Anti-IgE-therapy Group
Headache	Nervous system disorders	—	—
Fatique	Nervous system disorders	—	—
Fever	Immune system disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Rise in transaminases	Gastrointestinal disorders	—	—
Limb or joint pain or oedema	Musculoskeletal and connective tissue disorders	—	—
Lip swelling	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Pneumopleuritis and pericarditis.

Data from ClinicalTrials.gov NCT04158050 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A comparison of biologicals in the treatment of adults with severe asthma - real-life experiences.
   Kotisalmi E, Hakulinen A, Mäkelä M, Toppila-Salmi S, et al · · 2020 · cited 18× · PMID 32467765 · DOI 10.1186/s40733-020-00055-9