Study of Magnitude and Prediction of Response to Omalizumab and Mepolizumab in Adult Severe Asthma.

Summary

Pragmatic trial to define the magnitude and the predictive factors of the response to omalizumab and mepolizumab in adult patients with severe refractory asthma and eligible to both therapies.

Conditions

• Severe Asthma

Interventions

DRUG

Randomisation to omalizumab

The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate.

DRUG

Randomisation to mepolizumab

The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate.

Sponsors & Collaborators

• University Hospital, Ghent

  collaborator OTHER

• University of Liege

  collaborator OTHER

• CHU de Charleroi

  collaborator OTHER

• Erasme University Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire UCLouvain Namur

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Brugmann University Hospital

  collaborator OTHER

• Grand Hôpital de Charleroi

  collaborator OTHER

• AZ Delta

  collaborator OTHER

• Centre Hospitalier Universitaire Saint Pierre

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  lead OTHER

Principal Investigators

• Charles Pilette · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-10

Primary Completion

2023-12-31

Completion

2024-12-31

Countries

• Belgium

Study Locations