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A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma (MONA)
This study has been completed.

First Received on May 26, 2008.   Last Updated on March 15, 2011   History of Changes
Sponsor: Horizon Pharma, Inc.
Information provided by: Horizon Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00686335
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: modified release tablet formulation of prednisone
Phase II

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma

Resource links provided by NLM:


Further study details as provided by Horizon Pharma, Inc.:

Primary Outcome Measures:
  • Variation in the total number of nocturnal awakenings [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Variation of lung function parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: modified release tablet formulation of prednisone
    individual daily dose
    Other Name: Lodotra®
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686335

Locations
France
Hôpital Bichat
Paris, France, 75018
Sponsors and Collaborators
Horizon Pharma, Inc.
Investigators
Principal Investigator: Michel Aubier, Prof. Dr. Hôpital Bichat, Paris, France
  More Information

No publications provided

Responsible Party: Chief Medical Officier, Horizon Pharma
ClinicalTrials.gov Identifier: NCT00686335     History of Changes
Other Study ID Numbers: NP01-201, EudraCT-Number: 2007-007316-29
Study First Received: May 26, 2008
Last Updated: March 15, 2011
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by Horizon Pharma, Inc.:
asthma
nocturnal asthma
glucocorticoid dependent persistent asthma
signs and symptoms
lung function
prednisone

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012