A New Modified-Release Tablet Formulation of Prednisone (Lodotra) in Patients with Nocturnal AsthmaAn open-label explorative study - The MONA Study

itec Pharma AG0 个研究点目标入组 30 人开始时间: 2008年3月10日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•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

•Main exclusion criteria
•- Poorly controlled asthma, defined as meeting at least one of the following within the 4 weeks prior to Visit V0:
•ohospital admission for asthma (including treatment in an emergency room),
•oa 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

发起方

itec Pharma AG