NCT03476109

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2019

Longer than P75 for phase_4

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

4.6 years

First QC Date

October 17, 2017

Last Update Submit

October 26, 2022

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (3)

  • Efficacy on asthma symptoms

    Asthma Control Test: 5 items of score 1 to 5 about symptoms, with result of 20 or above indicates good control; 15 to 19 indicates no good control and below 15 indicates no control at all, and a change of 3 points considered as clinically significant.

    Up to 22 months

  • Efficacy on lung function

    Lung function measured as forced expiratory volume in one sec (FEV1), % predicted value (normal value of 80% predicted or above, and change of 100 mL considered as clinically significant).

    Up to 22 months

  • Efficacy on severe exacerbations

    Number of exacerbation(s) per period of time (corrected per year) requiring systemic corticosteroid treatment for at least 3 days, and/or emergency visit or hospitalization for acute asthma.

    Up to 22 months

Secondary Outcomes (1)

  • Predictive factors of therapeutic response

    Baseline features (and according to response at 22 months)

Study Arms (2)

Omalizumab

ACTIVE COMPARATOR

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.

Drug: Randomisation to mepolizumab

Mepolizumab

ACTIVE COMPARATOR

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.

Drug: Randomisation to omalizumab

Interventions

Randomisation to omalizumabDRUG

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.

Also known as: Active-controlled
Mepolizumab
Randomisation to mepolizumabDRUG

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.

Also known as: Active-controlled
Omalizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18+ years at time of signing ICF,
  • Able to comply with the study protocol, in the investigator's judgment,
  • Documented physician-diagnosed asthma ,
  • Patients with severe disease and eligible to omalizumab and mepolizumab, and who have not yet received any of these therapies.

You may not qualify if:

  • History of evidence of drug/substance abuse that would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or affect the patient's ability to participate in the study, in the opinion of the investigator
  • Treatment with any investigational therapy within 6 months or 5 drug half-lives prior to enrolment.
  • Known sensitivity to any of the active substances or their excipients to be administered during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

NOT YET RECRUITING

CHU de Charleroi

Charleroi, Hainaut, 6000, Belgium

NOT YET RECRUITING

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6000, Belgium

NOT YET RECRUITING

Katholieke Universiteit Leuven

Leuven, Vlaams Brabant, 3000, Belgium

NOT YET RECRUITING

AZ Delta Roeselare

Roeselare, West-vlaanderen, 8800, Belgium

NOT YET RECRUITING

Centre Hospitalier Universitaire Saint Pierre

Brussels, 1000, Belgium

NOT YET RECRUITING

Brugmann University Hospital

Brussels, 1020, Belgium

NOT YET RECRUITING

Erasme University Hospital

Brussels, 1070, Belgium

NOT YET RECRUITING

Cliniques universitaires St-Luc

Brussels, 1200, Belgium

RECRUITING

University Hospital, Ghent

Ghent, 9000, Belgium

NOT YET RECRUITING

University Hospital of Liege

Liège, 4000, Belgium

NOT YET RECRUITING

CHR Namur

Namur, 5000, Belgium

NOT YET RECRUITING

Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

Namur, 5530, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Charles Pilette

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Pilette, MD PhD

CONTACT

003227642866charles.pilette@uclouvain.be

Irina KAIDALINA-MAMBOUR, Inf

CONTACT

003227642813irina.kaidalina-mambour@uclouvain.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The analysis of the response rate and magnitude, as well as of biomakers predicting the response, will be performed by an independent assessor and a biostatistician.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Severe asthma patients who are eligible to both anti-IgE (omalizumab) and anti-IL-5 (mepolizumab) therapies, will be randomized to decide the first treatment to start. Patients will then be prolonged or switched to the other according to the clinical response. There will be 5 possibilities: oma(lizumab) group, mepo(lizumab) group, oma-mepo switch, mepo-oma switch, and oma/mepo failure.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

March 23, 2018

Study Start

May 10, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(13)