Similarities and Differences of Biological Therapies for Severe Asthma.

Asthma Clinical Trial

Official title:

Similarities and Differences of Biological Therapies for Severe Asthma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665141
• Other study ID #: BIO-ALER-2021-01
• Status: Recruiting
• Start date: April 7, 2021
• Est. completion date: November 2022

Study information

• Verified date: December 2020
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: Marta López de Calle
• Phone: +34948425600
• Email: mlopezdecal[@]unav.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Mepolizumab
Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
• Omalizumab
Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
• Reslizumab
Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
• Benralizumab
Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
• Dupilumab
Dupilumab will be prescribed freely by the treating physician according to real-life conditions.

Locations

Country	Name	City	State
Spain	Hospital Civil-Hospital Regional Universitario de Málaga	Málaga

Sponsors (3)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Hospital Clinic of Barcelona, Hospital Regional de Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment dose scheduling and changes of dose throughout the study.		2 years after inclusion
Primary	Number of treatment discontinuations and causes of interruption throughout the study.		2 years after inclusion
Primary	Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.		2 years after inclusion
Primary	Severity of Treatment-Related Adverse Events recorded throughout the study.		2 years after inclusion
Primary	Change of asthma control during the treatment.	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