A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Treatments: Prednisone

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.)