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.
Full Title of Study: “A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2010
- Drug: Lodotra
- 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.
- Drug: Cortancyl
- 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).
Arms, Groups and Cohorts
- Experimental: Lodotra
- After the 4 week run-in period with immediate release prednisone (Cortancyl), patients were switched to the identical dose of modified release prednisone tablets (Lodotra). Study medication for the Lodotra treatment period consisted of Lodotra in 2 dose strengths (5 mg and 1 mg prednisone per tablet). Patients were to take their tablets with or after the evening meal (at 10 pm +/- 30 minutes) for 4 weeks.
- Active Comparator: Cortancyl
- During the 4 week run-in period, patients remained on their respective pre-study dose of prednisone or equivalent. However, patients were standardized to 5 mg and 1 mg tablets of immediate release prednisone (Cortancyl). Patients were to take their tablets with or after the morning meal (at 8am +/- 30 minutes) for 4 weeks.
Clinical Trial Outcome Measures
- Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment
- Time Frame: 4 weeks and 8 weeks
- Variation in the total number of nocturnal awakenings during the last 2 weeks of run-in treatment with Cortancyl and the last 2 weeks of treatment with Lodotra.
Participating in This Clinical Trial
- 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.)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Horizon Pharma Ireland, Ltd., Dublin Ireland
- Provider of Information About this Clinical Study
- Overall Official(s)
- Michel Aubier, Prof. Dr., Principal Investigator, Hôpital Bichat, Paris, France
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