Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Study with completed results acquired from Horizon in 2024.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The subject must be able to understand the terms of the written informed consent form, and must provide a dated and signed form before the start of any study procedure
At least 18 years old
Patient having a diagnosis of asthma dating back more than 6 months at the time of inclusion
Asthma necessitating a continuous treatment by oral corticoids
A minimum of 3 nocturnal awakenings due to asthma during the last screening week
Stable dose of oral glucocorticoids for at least 4 weeks prior to inclusion into the study
No change in asthma medication during the last 4 weeks prior to V0
Non-smoker or ex-smoker (having stopped smoking more than one year previously and with a smoking history of less than 10 pack years )
Female patients of childbearing potential must be using a medically accepted contraceptive regimen
Able to perform the required study procedures including handling of medication containers and diaries
You may not be if
Poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to Visit V0:
* hospital admission for asthma (including treatment in an emergency room),
* a lower airway infection,
Diagnosis of chronic obstructive pulmonary disease or other relevant lung diseases (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, active tuberculosis, interstitial lung disease)
Clinically significant abnormalities of the hematological or biochemical constants
Pregnancy or breastfeeding
Participation in another clinical study within 30 days preceding Visit V0,
Re-entry of patients previously enrolled in this trial,
Suspected inability or unwillingness to comply with the study procedures
Alcohol or drug abuse
Need to take a non-authorised concomitant treatment (cf. list of medicaments not authorised during the study) in the course of the study
Other disease requiring treatment with corticosteroids
Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Patient with a hospitalisation scheduled during the study period
Any uncontrolled concomitant disease requiring further clinical evaluation (e.g. uncontrolled diabetes, uncontrolled hypertension, etc.)
