Asthma MedDRA version: 10.1 Level: LLT Classification code 10003553 Term:
Conditions
Interventions
Trade Name: Lodotra®
Product Name: Lodotra®
Product Code: NP01
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Nitec Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria - Written informed consent form - aged 18-65 years - 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 For inclusion in the Lodotra treatment period - Compliance in filling in the patient diary. - Absence of asthma exacerbation during the run-in period (an exacerbation is defined by an increase in the corticoid dose, an emergency consultation or a hospitalisation for asthma) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main exclusion criteria - Poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to Visit V0: o hospital admission for asthma (including treatment in an emergency room), o a lower airway infection, - Diagnosis of chronic obstructive pulmonary disease or other relevant lung diseases - 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 - Patient with a hospitalisation scheduled during the study period - Any uncontrolled concomitant disease requiring further clinical evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate, in subjects suffering from glucocortico-dependent persistent asthma, the efficacy and safety of Lodotra administered by oral route at 10 pm on the nocturnal symptoms of asthma and on respiratory function, compared to the usual administration of the equivalent dose of immediate-release prednisone (administered at 8 am).;Secondary Objective: To investigate the safety and tolerability of the modified-release tablet formulation of prednisone;Primary end point(s): The primary endpoint is the variation in the total number of nocturnal awakenings between the last week of run-in and the last week of treatment by Lodotra. | — |
Countries
France
Outcome results
None listed