A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Lodotra; Cortancyl
Intervention description: Administered with food at approximately 10 pm during the 4 week treatment period; patients received the identical dose of Lodotra as received of IR prednisone during the run-in period.; Administered in the morning with food during the 4 week run-in period; patients remained on their respective pre-study dose of prednisone or equivalent standardized to 5 mg and 1 mg tablets of immediate release (IR) prednisone (Cortancyl).
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: asthma; nocturnal asthma; glucocorticoid dependent persistent asthma; signs and symptoms; lung function; prednisone

Summary:

      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.
    

Eligibility criteria:

        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.)