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

Overview

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

• 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

Interventions

• 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

Primary 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

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.)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Horizon Pharma Ireland, Ltd., Dublin Ireland
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Michel Aubier, Prof. Dr., Principal Investigator, Hôpital Bichat, Paris, France