The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.

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.)

Adverse event data were collected from the time the patient gave informed consent until the end of the follow-up visit or 30 days after last study drug administration, whichever occurred later.

Safety was evaluated by:

• recording of Adverse Events (AEs) and concomitant treatments at each visit
• physical examination and vital sign measurements at each visit
• laboratory safety assessments at visits V0 and V4

This was an explorative study to collect data for a subsequent controlled trial and therefore no hypothesis testing was performed. The size of the efficacy population (N=7) is too small to detect any statistically significant changes.