Comparison of Biologicals in Treatment of Severe Asthma (BiSA)

February 28, 2023 updated by: Paula Kauppi, MD, PhD, Helsinki University Central Hospital

Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
anti-IL5/IL5R-therapy group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R
Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
anti-IgE-therapy group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy
Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab
mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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 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 courses of antimicrobics
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Number of Polypectomy, FESS and Ethmoidectomy
Time Frame: The baseline (before biologicals) and the latest 12 months after initiation of biologicals
Change in number of Polypectomy, FESS and ethmoidectomy
The baseline (before biologicals) and the latest 12 months after initiation of biologicals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ida Montini foundation, www.tb-foundation.org

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paula Kauppi, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUS/25/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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