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.
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.)
