Trial · NCT04158050

Comparison of Biologicals in Treatment of Severe Asthma

NCT04158050, Completed, Helsinki University Central Hospital; results first posted 2023-12-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Biologicals in Treatment of Severe Asthma. Trials, record NCT04158050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04158050

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Biologicals in Treatment of Severe Asthma
NCT number: NCT04158050
Status: Completed
Enrollment: 64 participants, actual
Lead sponsor: Helsinki University Central Hospital
Conditions: Asthma
Interventions: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
First posted: 2019-11-08
Last updated: 2023-12-04
Results first posted: 2023-12-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Number of Exacerbations of the Participants	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.
Secondary	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 oral corticosteroid dose in milligrams
Secondary	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 courses of antimicrobics
Secondary	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	Change in the number of emergency room visits of the participants
Other	Change in Number of Polypectomy, FESS and Ethmoidectomy	The baseline (before biologicals) and the latest 12 months after initiation of biologicals	Change in number of Polypectomy, FESS and ethmoidectomy

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Number of Exacerbations of the Participants	baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)	Change in number of courses of oral c	MEAN
SECONDARY	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	Milligrams	MEAN
SECONDARY	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 antimicrobial courses/year	MEAN
SECONDARY	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	Change in number of emergency visits	MEAN
OTHER_PRE_SPECIFIED	Change in Number of Polypectomy, FESS and Ethmoidectomy	The baseline (before biologicals) and the latest 12 months after initiation of biologicals	Procedures	MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Number of Exacerbations of the Participants	Anti-IL5/IL5R-therapy Group		2.77	Standard Deviation 7.91	Change in number of courses of oral c
Change in Number of Exacerbations of the Participants	Anti-IgE-therapy Group		1.32	Standard Deviation 2.01	Change in number of courses of oral c
Change in Oral Corticosteroid Dose in Milligrams	Anti-IL5/IL5R-therapy Group		3.0	Standard Deviation 7.91	Milligrams
Change in Oral Corticosteroid Dose in Milligrams	Anti-IgE-therapy Group		2.29	Standard Deviation 5.80	Milligrams
Change in the Number of Courses of Antimicrobics	Anti-IL5/IL5R-therapy Group		0.69	Standard Deviation 2.08	Change in antimicrobial courses/year
Change in the Number of Courses of Antimicrobics	Anti-IgE-therapy Group		0.23	Standard Deviation 1.47	Change in antimicrobial courses/year
Change in the Number of Emergency Room Visits of the Participants	Anti-IL5/IL5R-therapy Group		0.29	Standard Deviation 1.30	Change in number of emergency visits
Change in the Number of Emergency Room Visits of the Participants	Anti-IgE-therapy Group		0.18	Standard Deviation 1.19	Change in number of emergency visits
Change in Number of Polypectomy, FESS and Ethmoidectomy	Anti-IL5/IL5R-therapy Group	Polypectomy	1.24	Standard Deviation 3.03	Procedures
Change in Number of Polypectomy, FESS and Ethmoidectomy	Anti-IgE-therapy Group	Polypectomy	1.41	Standard Deviation 4.69	Procedures

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Anti-IL5/IL5R-therapy Group	42
Overall Study	STARTED	Anti-IgE-therapy Group	22
Overall Study	COMPLETED	Anti-IL5/IL5R-therapy Group	33
Overall Study	COMPLETED	Anti-IgE-therapy Group	17
Overall Study	NOT COMPLETED	Anti-IL5/IL5R-therapy Group	9
Overall Study	NOT COMPLETED	Anti-IgE-therapy Group	5

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Anti-IL5/IL5R-therapy Group	2	42	2
other	Headache	Nervous system disorders	Anti-IgE-therapy Group	1	22	1
other	Fatique	Nervous system disorders	Anti-IL5/IL5R-therapy Group	1	42	1
other	Fatique	Nervous system disorders	Anti-IgE-therapy Group	1	22	1
other	Fever	Immune system disorders	Anti-IL5/IL5R-therapy Group	1	42	1
other	Fever	Immune system disorders	Anti-IgE-therapy Group	0	22	0
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Anti-IL5/IL5R-therapy Group	0	42	0
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Anti-IgE-therapy Group	1	22	1
other	Rise in transaminases	Gastrointestinal disorders	Anti-IL5/IL5R-therapy Group	1	42	1
other	Rise in transaminases	Gastrointestinal disorders	Anti-IgE-therapy Group	0	22	0

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Anti-IL5/IL5R-therapy Group	0	42
Total, all-cause mortality	Anti-IgE-therapy Group	0	22
Total, other adverse events	Anti-IL5/IL5R-therapy Group	7	42
Total, other adverse events	Anti-IgE-therapy Group	4	22
Total, serious adverse events	Anti-IL5/IL5R-therapy Group	1	42
Total, serious adverse events	Anti-IgE-therapy Group	0	22

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32467765	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Anti-IL5/IL5R-therapy Group vs Anti-IgE-therapy Group: deaths from any cause	Trial comparisons
Anti-IL5/IL5R-therapy Group vs Anti-IgE-therapy Group: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT04158050/registered

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