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

Phase 2

Completed

Brief 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.

Detailed Description: Study with completed results acquired from Horizon in 2024.

Recruitment & Eligibility

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.)

Arm && Interventions

Group	Intervention	Description
Lodotra	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.
Cortancyl	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.

Primary Outcome Measures

Name	Time	Method
Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment	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.

Secondary Outcome Measures