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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study ID
NCT03476109
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Randomisation to omalizumab — DRUG
    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.
  • Randomisation to mepolizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 10, 2019
Status verified
Oct 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Omalizumab
    Patients randomized to omalizumab and then prolonged or not (based on their response at 4 months) until the end of the study (22mo). Non responders will be switched to mepolizumab arm.
  • Active Comparator: Mepolizumab
    Patients randomized to mepolizumab and then prolonged or not (based on their response at 6 months) until the end of the study (22mo). Non responders will be switched to omalizumab arm.

Primary Outcome Measure

Efficacy on asthma symptoms [ Time Frame: Up to 22 months ]

Central Contacts

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