Predictive factors and magnitude of response to omalizumab and mepolizumab in allergic and eosinophilic severe asthma: PREDICTUMAB, an open-label, controlled, randomized multinational pragmatic trial.

Prior treatment

• Patient already currently/actively enrolled in a clinical therapeutic trial (testing another drug); the concomitant inclusion in a Registry, which may include biosampling, is not an exclusion criterion

Other illness

• 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
• Difficult to treat asthma and others severe respiratory diseases
• Active malignancy or malignancy in remission over less than 5 years

Other

• Protected subjects (sous tutelle or curatelle), patients who are unable to express their consent, subjects who are deprived of liberty, subjects who are hospitalized without consent, subjects who are admitted in a health-care or social institute with another aim than that of the research, inclusion in an emergency situation, patient who is subject to a court order
• Pregnant, post-partum or lactating women
• Known sensitivity to any of the active substances or their excipients to be administered during the study
• Patient not affiliated to a health insurance plan (FR)

• Signed informed consent form (ICF)
• Age >18+ years (18-90 years old) at time of signing ICF
• Able to comply with the study protocol, in the investigator’s judgment
• Documented physician-diagnosed asthma
• Eligible to omalizumab and mepolizumab and who have not yet received any of these therapies