A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma

Study with completed results acquired from Horizon in 2024.

Inclusion criteria

• 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

Exclusion criteria

• 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.)