AsthmaBiSANCT04158050

Comparison of Biologicals in Treatment of Severe Asthma

An observational study of Asthma, run by Helsinki University Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
How many people: 64 participants
Where: 1 siteFinland
Study dates: 1 Jan 2018to 31 Oct 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

Study population: Asthma patients that have received biologicals (anti-IL5/IL5R or anti-IgE) for asthma with or without chronic rhinitis and nasal polyps.

Who may be able to join

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

Who cannot join

patients without asthma

Trial locations and contacts

1 site in 1 country.

Finland1 site

Helsinki University Central Hospital
Helsinki, 00029

Other trials in Finland

About this study

Official title: Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences

Read the detailed description

The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.

Conditions: Asthma
Being tested: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IL5 Antagonist or anti-IL5R-antibody or OmalizumabDrug
mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

Study groups in NCT04158050
Study group	Role	What they receive
anti-IL5/IL5R-therapy group		Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R Receives: Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
anti-IgE-therapy group		Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy Receives: Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Number of Exacerbations of the Participants
Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids.
Measured: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)

Secondary outcomes (3)

Change in Oral Corticosteroid Dose in Milligrams
Change in oral corticosteroid dose in milligrams
Measured: 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 the Number of Courses of Antimicrobics
Change in the number of courses of antimicrobics
Measured: 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
Change in the number of emergency room visits of the participants
Measured: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201831 Oct 2020

First posted8 Nov 2019
Study start1 Jan 2018
Primary completion31 Oct 2020
Study completion31 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04158050
Sponsor's protocol ID: HUS/25/2019
Acronym: BiSA
Status last verified: Feb 2023
First submitted: 3 Nov 2019
Last updated: 4 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Kotisalmi E, Hakulinen A, Makela M, Toppila-Salmi S, Kauppi P. A comparison of biologicals in the treatment of adults with severe asthma - real-life experiences. Asthma Res Pract. 2020 May 13;6:2. doi: 10.1186/s40733-020-00055-9. eCollection 2020.
PubMed 32467765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences
ClinicalTrials.gov ID: NCT04158050
Acronym / sponsor ID: BiSA / HUS/25/2019
Conditions: Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Helsinki University Central HospitalUniversity, hospital or other
Collaborators: Ida Montini Foundation
Study start: 1 Jan 2018 (actual)
Primary completion: 31 Oct 2020 (actual)
Study completion: 31 Oct 2020 (actual)
First posted: 8 Nov 2019 (actual)
Results: Posted 4 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
anti-IL5/IL5R-therapy group	–	Drug: IL5 Antagonist or anti-IL5R-antibody or OmalizumabAsthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R
anti-IgE-therapy group	–	Drug: IL5 Antagonist or anti-IL5R-antibody or OmalizumabAsthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Asthma patients that have received biologicals (anti-IL5/IL5R or anti-IgE) for asthma with or without chronic rhinitis and nasal polyps.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

patients without asthma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IL5 Antagonist or anti-IL5R-antibody or Omalizumabmepolizumab, reslizumab, benralizumab and omalizumab in severe asthma	Drug	anti-IL5/IL5R-therapy group, anti-IgE-therapy group

Primary outcome

Change in Number of Exacerbations of the Participants
Time frame: 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.

3 secondary outcomes

Change in Oral Corticosteroid Dose in Milligrams
Time frame: 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 the Number of Courses of Antimicrobics
Time frame: 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
Time frame: The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals

Results and safety

Results posted to the registry on 4 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anti-IL5/IL5R-therapy Group	42	33
Anti-IgE-therapy Group	22	17

Primary outcome: Change in Number of Exacerbations of the Participants

Time frame: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals). Mean (Standard Deviation). Unit: Change in number of courses of oral c

Measure	Anti-IL5/IL5R-therapy Group n = 42	Anti-IgE-therapy Group n = 22
Value	2.77 (7.91)	1.32 (2.01)

3 secondary outcomes are reported in the full results.

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anti-IL5/IL5R-therapy Group	1 of 42 (2.4%)	7 of 42 (16.7%)	0 of 42
Anti-IgE-therapy Group	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32467765Kotisalmi E, Hakulinen A, Makela M, Toppila-Salmi S, Kauppi P. A comparison of biologicals in the treatment of adults with severe asthma - real-life experiences. Asthma Res Pract. 2020 May 13;6:2. doi: 10.1186/s40733-020-00055-9. eCollection 2020.
Individual participant dataSharing planned: Undecided

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paula Kauppi, MD, PhD principal investigator

Helsinki University Central Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Helsinki University Central Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Exacerbations of the Participants (time frame: baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04158050, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.