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

November 27, 2012 updated by: Horizon Pharma Ireland, Ltd., Dublin Ireland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75018
        • Hopital Bichat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • modified release tablet formulation of prednisone
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.
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).
Other Names:
  • immediate release prednisone tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horizon Pharma Ireland, Ltd., Dublin Ireland

Investigators

  • Principal Investigator: Michel Aubier, Prof. Dr., Hôpital Bichat, Paris, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 26, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP01-201
  • EudraCT-Number: 2007-007316-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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