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

Asthma Clinical Trial

— MONA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686335
• Other study ID #: NP01-201
• Secondary ID: EudraCT-Number:
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2008
• Last updated: November 27, 2012
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2012
• Source: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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).

Locations

Country	Name	City	State
France	Hôpital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Pharma Ireland, Ltd., Dublin Ireland

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Nocturnal Awakenings During the Last 2 Weeks of Treatment	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.	4 weeks and 8 weeks	No