Similarities and Differences of Biological Therapies for Severe Asthma.

April 23, 2021 updated by: Clinica Universidad de Navarra, Universidad de Navarra
This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma.

In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

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

Study Contact

Study Locations

  • Spain
      • Málaga, Spain, 29009
        • Recruiting
        • Hospital Civil-Hospital Regional Universitario de Málaga
        • Contact:
          • Mª José Torres

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

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients, adults and children, with a diagnosis of severe asthma in the participating centers.

Description

Inclusion Criteria:

  • Individuals of any age: adults and children.
  • Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased.
  • Being treated or not (control group) with biological drugs.
  • Signed Informed Consent.

Exclusion Criteria:

  • None.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of care
Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids.
Biological therapies
Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab.
Biological: Mepolizumab
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
Other Names:
  • Nucala®
Biological: Omalizumab
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
Other Names:
  • Xolair®
Biological: Reslizumab
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
Other Names:
  • Cinqair®
Biological: Benralizumab
Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
Other Names:
  • Fasenra®
Biological: Dupilumab
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.
Other Names:
  • Dupixent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment dose scheduling and changes of dose throughout the study.
Time Frame: 2 years after inclusion
2 years after inclusion
Number of treatment discontinuations and causes of interruption throughout the study.
Time Frame: 2 years after inclusion
2 years after inclusion
Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.
Time Frame: 2 years after inclusion
2 years after inclusion
Severity of Treatment-Related Adverse Events recorded throughout the study.
Time Frame: 2 years after inclusion
2 years after inclusion
Change of asthma control during the treatment.
Time Frame: 2 years after inclusion
Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids.
2 years after inclusion

Collaborators and Investigators

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

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Hospital Clinic of Barcelona
Hospital Regional de Malaga

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)

April 7, 2021

Primary Completion (ANTICIPATED)

November 1, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-ALER-2021-01

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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